Category: Health and wellness News Commentary

According to a recent report published by Forbes & Brightfield Group, the data projects that the global cannabis market was worth USD 7.7 Billion in the end of 2017, and is expected to reach USD 31.4 Billion by 2021. The United States accounts for about 90% of the whole market. However, the U.S. domination of the market is likely to decrease to approximately 57%, due to the legalization of cannabis products in other nations. California”s new recreational cannabis laws went into effect on January 1st, 2018. While California is the largest market, Canada is projected to show strong sales as well. Data by Deloitte report estimates the Canadian market will be worth at least USD 5 Billion in sales in 2018. CLS Holdings USA Inc. (OTC: CLSH), Supreme Cannabis Company Inc. (OTC: SPRWF), Emerald Health Therapeutics Inc. (OTC: EMHTF), Terra Tech Corp. (OTC: TRTC), iAnthus Capital Holdings Inc. (OTC: ITHUF)

In the U.S., the potential financial benefits from legalization are important economically and politically. In a report by Benzinga, Viridian Capital President, Scott Greiper, points out that the cannabis market received USD 1.23 Billion in investments in the first five weeks of 2018, up from USD 178 Million a year earlier. Viridian Capital Advisors” Vice President, Harrison Phillips, explained, ‘Investments in cultivation and retail this year have been driven predominantly by the Canadian player. This has been happening pretty consistently from late 2016 through 2017. This reflects the necessity to scale cannabis businesses, to get some kind of advantage, and to explore strategic opportunities, both through acquisitions and international expansion.’

CLS Holdings USA Inc. (OTCQB: CLSH) on June 28th, announced breaking news that, ‘the successful closing of its acquisition of Oasis Cannabis. CLS is now active in the legalized cannabis market in Las Vegas, NV, generating USD 850,000 in gross monthly revenue.

Oasis Cannabis is a fully integrated cannabis operation in Las Vegas, Nevada. Since 2017, Oasis has been involved in growing, extraction, conversion, processing and operating a dispensary. Its grow, extraction, conversion and processing facility had its best month ever last month in generating USD 200,000 in gross revenues. Due to increased demand and the additional capital that was just raised, CLS plans to triple the grow production capacity over the remainder of 2018. On the retail dispensary side, Oasis has steadily witnessed increased traffic over the past few months, is now up to 400 daily visitors, and is currently generating USD 650,000 of gross monthly revenue.

Oasis”s City Trees wholesale product line recently more than doubled its number of product SKUs offered to retail dispensary customers and now covers a variety of concentrates, vape pens, and capsules, and tinctures including high CBD versions. The City Trees product line is now being sold in over 20 dispensaries in the Las Vegas and Reno markets.’

CLS Chief Executive, Jeff Binder, commented, ‘We are thrilled to have successfully completed the acquisition of Oasis Cannabis. We are thankful to our existing long-term shareholders for their patience and our new investors who share our enthusiasm and excitement for the Nevada market with Oasis and additional expansion opportunities as they evolve. We look forward to building out a significant and diversified cannabis operation with multiple locations. We believe this is just the beginning for CLS and anticipate great things to come.’

Ben Sillitoe, Co-Founder of Oasis Cannabis, commented, ‘This is an exciting time for the entire Oasis team. The closing of this transaction is a major milestone for our strategic growth plans. As we add new locations and expand our product manufacturing and cultivation facilities there will be more jobs created and additional opportunities for our existing team to advance in their careers. I”m personally honored by all of this. This is such a unique time in our country”s history and I”m very proud to be a part of the movement to end cannabis prohibition. Now that our entire Nevada operation is a wholly owned subsidiary of a publicly-traded company there is more opportunity for people to be a part of it.’

Supreme Cannabis Company Inc. (OTC: SPRWF) is a Canadian publicly traded company committed to becoming a leading cultivator and distributor of sun grown cannabis through its wholly-owned subsidiary 7ACRES. Earlier this month, the Company announced that it has entered into a definitive agreement pursuant to which Supreme Cannabis will complete a CAD 10,000,000 strategic equity investment in Medigrow. Upon completion of the Investment, Supreme Cannabis will hold an approximate 10% ownership interest in Medigrow. Supreme Cannabis expects strong demand to exceed supply for medical cannabis oil globally and believes Lesotho is well suited to produce quality cannabis oil and Medigrow possesses the expertise to meet the highest quality standards. Concurrent with the completion of the Investment, Supreme Cannabis and Medigrow have agreed to enter into a long-term global distribution partnership for medical cannabis oil. The cannabis oil will be produced by Medigrow in Lesotho and subject to all government, and international regulatory approvals, the oil will be exported to Canada and other international markets.

Emerald Health Therapeutics Inc. (OTCQX: EMHTF) is a Licensed Producer under Canada”s Access to Cannabis for Medical Purposes Regulations and produces and sells dried cannabis and cannabis oil for medical purposes. Recently, the Company and Village Farms International, Inc., announced that their 50/50 joint venture for large-scale, low-cost, high-quality cannabis production, Pure Sunfarms, received an amendment to its cultivation license for its Delta 3 greenhouse in Delta, BC, from Health Canada. This amendment permits Pure Sunfarms to substantially expand its cannabis production to 225,000 sq. ft. of the 1.1-Million sq. ft. Delta 3 production facility. In mid-May, Pure Sunfarms initiated commercial-scale production on 130,000 sq. ft. at the Delta 3 greenhouse, which is now fully utilized, with harvesting expected to begin in August. Planting in the newly-licensed area will commence this week and is expected to be completed by the end of July. Pure Sunfarms expects to have the full 1.1 Million sq. ft. Delta 3 facility, one of the single largest cannabis growing facilities in the world, converted to cannabis production by year end.

Terra Tech Corp. (OTCQX: TRTC) is a vertically integrated cannabis-focused agriculture company. Earlier in June, the Company announced that it has commenced cultivation at its new Sparks facility, following approval from the State of Nevada. Utilizing Terra Tech”s proven practices and procedures, the team has successfully begun cultivation of its first cannabis crop, planting the first seeds in early June. Terra Tech expects to distribute and sell cannabis grown at the Sparks facility from its first harvest throughout Nevada by the fourth quarter of 2018. Construction of the 30,000 sq. ft. cultivation facility was completed during the first quarter of 2018, in conjunction with NuLeaf Sparks. The Sparks facility was built out using LED lights to increase efficiencies and reduce the cost of production. Terra Tech”s proprietary IVXX cannabis products will be grown and harvested at the Sparks facility under the safest and most beneficial conditions.

iAnthus Capital Holdings Inc. (OTCQB: ITHUF) owns and operates best-in-class licensed cannabis cultivation, processing and dispensary facilities throughout the United States, providing investors diversified exposure to the U.S. regulated cannabis industry. On June 12, 2018, the Company announced that Mayflower Medicinals Inc., has signed a Host Community Agreement with the City of Lowell, Massachusetts, to operate a Medical Marijuana Treatment Center located at 450 Chelmsford Street. Lowell, Massachusetts. Mayflower intends to diligently pursue a Special Permit at the site.  If granted, the dispensary is expected to be one of only two operating dispensaries within the Lowell city limits. Mayflower is a non-profit Massachusetts corporation that has received two provisional licenses to operate Registered Marijuana Dispensaries in Massachusetts, with a third RMD application pending before the Massachusetts Department of Public Health.

Subscribe Now! Watch us report LIVE

Follow us on Twitter for real time Financial News Updates:

Follow and talk to us on Instagram:

Facebook Like Us to receive live feeds:

About, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, creates 100% unique original content. also provides financial news PR dissemination, branding, marketing and advertising for third parties for corporate news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.

Please Note: is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on (the ”Site”) is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content),, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. receives fees for producing and presenting high quality and sophisticated content on along with other financial news PR media services. does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. For CLS Holdings USA, Inc. financial news dissemination and PR services, has been compensated five thousand dollars by the company. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. will always disclose any compensation in securities or cash payments for financial news PR advertising. does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security., members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use, please visit: .

For further information:
Media Contact:


NEW YORK, July 5, 2018 /PRNewswire/ —

Read Full Article News Commentary 

As the Canadian recreational cannabis market approaches its birth with legalization quickly approaching, leaders in the industry are preparing for the inevitable consumer demand through ramped up measures to add strategic locations as well as well as a growing number of mergers and acquisitions. As a whole, Canadians spent north of $5 billion on cannabis in 2017 according to data released by Statistics Canada. That number is projected to increase when recreational cannabis becomes readily available. One of the big reasons that marijuana is no longer being viewed as taboo was publish in an article published by Deloitte, titled ‘Recreational Marijuana Insights and Opportunities,’ as it found that the typical recreational marijuana consumers were not looking for a quick high but instead use marijuana for medical needs such as a sleep aid or stress reducer. Active companies in the industry making moves to ready that include: Choom™ Holdings Inc. (CSE:CHOO) (OTC:CHOOF), Hiku Brands Company Ltd. (OTC:DJACF) (CSE:HIKU), Medmen Enterprises Inc. (OTC:MMNFF) (CSE:MMEN), Newstrike Resources Ltd. (OTC:NWKRF) (TSX-V:HIP), Namaste Technologies Inc.”s (OTC:NXTFF) (TSX-V:N).

Choom™ Holdings Inc. (CSE: CHOO) (OTCQB: CHOOF) BREAKING NEWS: Choom™, an emerging, fully-integrated cannabis company, is pleased to announce that it has advanced the build-out of its cannabis retail store network in Alberta and British Columbia.

Choom™ has secured the rights to an additional 7 retail locations in Alberta. Choom has 25 leases in highly strategic and secure locations in Alberta with 24 applications submitted. Choom has also secured 3 additional B.C retail leases, combined with the existing 7, for a total of 10 retail opportunities in B.C. In all cases, the retail opportunities are subject to all necessary governmental and municipal approvals being granted. This number is expected to grow over the coming months as the Company is currently negotiating additional leases with the intention of submitting applications for retail licenses. The following link will bring you to our retail opportunity map:

‘This is a significant step towards establishing Choom”s strategy to be a leading private cannabis retailer in Canada,’ states Choom”s President and CEO, Chris Bogart, he also adds, ‘Market share and customer acquisition in the upcoming recreational landscape will be very difficult to come by, these applications are key to Choom”s retail strategy. Choom”s brand was created exclusively for the recreational market, core to our values is cultivating a great experience for the consumer and part of this strategy is retail distribution. We are committed to pursuing retail licensing opportunities across the country and remain focused on cultivating ”Good Time with Good Friends”.’ Read this and more news for Choom™ at: 

Additional industry related developments from around the markets:

Hiku Brands Company Ltd. (OTCPK:DJACF) (CSE:HIKU.CN) and WeedMD Inc. (WDDMF) recently announced that WeedMD has obtained an interim order from the Ontario Superior Court of Justice authorizing the holding of an annual and special meeting (the ‘WeedMD Meeting’) of WeedMD shareholders (‘WeedMD Shareholders’) to consider the previously announced merger (the ‘Merger Transaction’ or the ‘Arrangement’) between Hiku and WeedMD. As described in the joint Hiku and WeedMD press release dated April 19, 2018, WeedMD will be seeking WeedMD Shareholder approval for the Arrangement under the Business Corporations Act (Ontario) (the ‘Arrangement Resolution’). The WeedMD Meeting to consider the Arrangement Resolution will be held on Wednesday, July 11, 2018 at 10:00 a.m. (Toronto time) at Fogler, Rubinoff LLP, located at TD Centre North Tower, Suite 3000, 77 King Street, Toronto, Ontario.

Medmen Enterprises Inc. (OTCQB:MMNFF) (CSE:MMEN.CN) recently announced that the Company opened its newest store on Venice”s Abbot Kinney Boulevard on Saturday. With banks of news media cameras surrounding the storefront, Medmen co-founders Adam Bierman and Andrew Modlin cut the ribbon. They were flanked by U.S. congressman Ted Lieu, California state senator Ben Allen, assembly member Reggie Jones-Sawyer and celebrity Rosario Dawson. Lines of customers waited to enter the store. Mr. Lieu, whose district includes Abbot Kinney, welcomed customers and greeted the press. It marked the first known time an active U.S. congressman was featured in the grand opening of a marijuana dispensary. It underscored how mainstream marijuana has become, and how California is leading the way.

Newstrike Resources Ltd. (OTCPK:NWKRF) (TSX-V:HIP.V) recently announced its wholly owned subsidiary and licensed producer, Up Cannabis Inc., has joined the newly formed Global Cannabis Partnership as a founding member, and will contribute to its mandate of creating a worldwide social responsibility standard for the safe and responsible production, distribution, and consumption of legal adult-use cannabis. The partnership, announced earlier today at the World Cannabis Congress in Saint John, N.B., includes a wide range of stakeholders including government agencies, licensed producers and affiliate organizations that will focus on the legalized cannabis industry.

On June 18, further to Namaste Technologies Inc.”s (OTCQB:NXTFF) (TSX-V:N.V) Jan. 18, 2018, letter of intent that the company has signed a subscription agreement to acquire 10 per cent of the issued share capital of Israeli licensed producer of medical cannabis, Cannbit Ltd., for 2.5 million Israel new shekels or approximately $908,000, which includes a combination of both cash and shares. Subsequently, Cannbit has also signed a binding agreement to complete a merger with a company listed on the Tel Aviv Stock Exchange, whereby Cannbit will retain 85-per-cent ownership of the combined public entity, the company believes that its investment will be immediately accretive in nature based on the valuation metrics of the transaction which consequently valued Cannbit significantly higher than what Namaste acquired its 10-per-cent equity stake for. In anticipation of closing this transaction, Namaste has established a supply arrangement with Cannbit to export cannabis to the Canadian market (subject to approval by Health Canada and the Israeli government), and will also engage with Cannbit to expand the company”s Israeli-based vaporizer sales platform.

DISCLAIMER: (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU”s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers.  Investors are cautioned that they may lose all or a portion of their investment when investing in stocks.  For current services performed MNU has been compensated forty five hundred dollars for news coverage of the current press release issued above by Choom™ Holdings Inc. by a non affiliated third party. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains ‘forward-looking statements’ within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. ‘Forward-looking statements’ describe future expectations, plans, results, or strategies and are generally preceded by words such as ‘may’, ‘future’, ‘plan’ or ‘planned’, ‘will’ or ‘should’, ‘expected,’ ‘anticipates’, ‘draft’, ‘eventually’ or ‘projected’. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company”s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

Contact Information:
Media Contact
Phone – +1(561)325-8757

PALM BEACH, Florida, June 19, 2018 /PRNewswire/ —

Read Full Article

Purpose: To firstly study the anti-leukemic activity of the CLL1-CD33 compound CAR in vitro and in vivo and consequently offer opportunities to the treatment for refractory and relapsed AML patients.

     (Logo: )

Methods: We generated a cCAR targeting both CLL1 and CD33, then we evaluated the anti-leukemic activity by killing assays with multiple cell lines and in mouse models, next we study the depletion of CAR T cells in mouse body, finally we completed the first case of phase I clinical trial in a refractory AML patient.

Results: We successfully generated a cCAR that contains two independent complete units targeting CD33 that for a bulky leukemia and CLL1 for leukemic stem cells. In vitro assays indicated that CLL1-CD33 cCAR had specific anti-tumor activity against cell lines engineered expressing CLL1 or CD33, as well as leukemia samples from AML patients. In mouse models generated by cell lines engineered expressing CLL1 or CD33 and AML cell line U937 cells, the cCAR T cells significantly reduced tumor burden and prolonged survival. CD52 specific antibody CAMPATH could be used as a safety-switch to rapidly terminate cCAR therapy in mouse models. In the first-in-human phase 1 clinical trial, CLL1-CD33 cCAR T therapy was safe and well tolerated, and achieved complete response (CR).

Conclusion: Our preclinical study has shown that our CLL-1-CD33 cCAR possesses consistent, specific, and potent anti-tumor activity against CLL-1+ and/or CD33+ leukemia cells in vitro and in vivo. cCAR may have advantages over single-CAR therapy in terms of reduction of disease relapse by targeting LSC and bulky AML population. Phase 1 trial for CLL-1-CD33 cCAR are underway.

Presenter: Dr Fang Liu
Affiliation: Department of Hematology, Chengdu Military General Hospital, Chengdu, Sichuan, P.R. China

Abstract S149 will be presented by Fang Liu on Friday, June 15, 15:45-16:00 in Room A1.

Please note that our embargo policy applies to all selected abstracts in the Press Briefings. For more information check our Congress Media Guidelines here.


STOCKHOLM, June 15, 2018 /PRNewswire/ —

Read Full Article News Commentary 

Clinical trial data is an important catalyst as well as trial results or any positive updates on the clinical studies are often received well these days in the pharma and biotech market. The industry as whole has bounced back in the past month as it rose 6.8%, better than the S&P 500”s increase of 2.9% making it one of the best-performing industries in the U.S. stock market. On the bright side of things, indications are the demand for drugs is rising worldwide due to increasing ailing and elderly population, frequent approval of new drugs as well as line extensions of already marketed drugs and increased healthcare spending. In addition another positive indication for the biotech industry is the U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. Active companies in the markets today include: Moleculin Biotech, Inc. (NASDAQ:MBRX), Aptose Biosciences Inc. (NASDAQ:APTO), Cardiome Pharma Corp. (NASDAQ:CORV), Pfizer Inc. (NYSE:PFE), Endocyte Inc. (NASDAQ:ECYT).

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it has entered into an agreement with the Jagiellonian University in Krakow, Poland, for the development of its STAT3 inhibitor, WP1732, for the treatment of ocular tumors.

‘Today there are very limited options for the treatment of ocular tumors,’ commented Walter Klemp, Chairman and CEO of Moleculin. ‘And, these tumors are believed to involve a significant upregulation of the activated form of STAT3. It is important to note that, in addition to the ability of WP1732 to inhibit the proliferation and survival of cancer cells in preclinical studies, as STAT3 inhibitor, it is designed to potently block cancer stem cells and induce immune system function to overcome tumor-induced immune tolerance. This could make WP1732 an ideal candidate for targeting these unique and highly metastatic tumors.’

Mr. Klemp continued: ‘we remain committed to targeting accelerated approval pathways for WP1732 by focusing on significant unmet needs. This includes niche indications like ocular tumors and AML, as well as high-profile indications like pancreatic cancer.’ Read this and more news for Moleculin Biotech at:

In other pharma and biotech developments in the markets: 

Aptose Biosciences Inc. (NASDAQ:APTO) came to a close up 6.39% on Monday at $4.33 trading over 1 million shares by the market close. The company also recently annnounced the publication of preclinical data elucidating the mechanism of action of APTO-253, the company”s clinical stage anticancer product candidate. The data are published in two separate articles in the June 2018 issue (Volume 17, Number 6) of Molecular Cancer Therapeutics, a peer-reviewed journal of the American Association for Cancer Research (AACR). The first publication, entitled ‘APTO-253 stabilizes G-quadruplex DNA, inhibits MYC expression and induces DNA damage in acute myeloid leukemia cells,’ demonstrates that the APTO-253 small molecule anticancer agent inhibits expression of the MYC oncogene and depletes cells of the MYC protein, triggers the DNA repair and stress response pathways, and promotes programmed cell death (apoptosis) in acute myeloid leukemia (AML) cell lines and fresh bone marrow samples derived from patients with AML and other hematologic malignancies that often depend on MYC upregulation.

Cardiome Pharma Corp. (NASDAQ:CORV) closed up 48.08% on Monday at $3.08 trading oved 5.7 million shares by the market The company also announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path forward in the US for BRINAVESS® (vernakalant hydrochloride, IV), Correvio”s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its written reply, the FDA informed Correvio that it would be permissible to resubmit the BRINAVESS New Drug Application (NDA) and agreed that the Company may schedule a Pre-NDA meeting. Correvio currently expects that the Pre-NDA meeting with the FDA will take place in the fourth quarter of 2018. ‘In our most recent communication with the FDA, we asked the Agency if the Division of Cardiovascular and Renal Products would be willing to meet to discuss a regulatory path forward for Brinavess,’ said William Hunter, MD, CEO and President of Correvio. ‘We are pleased that the Agency has agreed to discuss Brinavess in a pre-NDA meeting, which we will seek to have in the fourth quarter.’

Pfizer Inc. (NYSE:PFE) recently announced that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company”s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population. ‘Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,’ said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development.

Endocyte Inc. (NASDAQ:ECYT) last week announced the enrollment of the first patient in its global phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr. Luke Nordquist at Urology Cancer Center in Omaha, NE, a member of Precision Cancer Research. The international, prospective, open-label, multicenter, randomized phase 3 study is evaluating patients with progressive prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), who have received at least one novel androgen axis drug (abiraterone or enzalutamide) and at least one taxane regimen. ‘We are pleased to announce the initiation of this important clinical trial so quickly following our end-of-phase 2 meeting with the FDA. This speed of execution is a result of the enthusiasm of participating physicians and the focus and urgency of our clinical operations team,’ said Mike Sherman, president and CEO of Endocyte. ‘Having collaborated with several of the key opinion leaders in prostate cancer around the world, we are confident in the robustness of the VISION trial design and eager to complete enrollment.’

DISCLAIMER: (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU”s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers.  Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated forty four hundred dollars for news coverage of the current press release issued by Moleculin Biotech, Inc. by the company. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains ‘forward-looking statements’ within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. ‘Forward-looking statements’ describe future expectations, plans, results, or strategies and are generally preceded by words such as ‘may’, ‘future’, ‘plan’ or ‘planned’, ‘will’ or ‘should’, ‘expected,’ ‘anticipates’, ‘draft’, ‘eventually’ or ‘projected’. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company”s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

Contact Information:

PALM BEACH, Florida, June 12, 2018 /PRNewswire/ —

Read Full Article

Envirotainer, the global market leader in secure cold chain solutions for the pharmaceutical supply chain, announced today that Swiss WorldCargo now has 36 QEP accredited stations, comprised of QEP Basic, Advanced and Expert levels. With 31 stations receiving the QEP Advanced accreditation, Swiss WorldCargo has the highest number of stations with this distinction within the industry. Alongside this, the airline”s Zurich hub has recently been recognized as a QEP Expert station, based on its GDP compliance and CEIV certification.

Bourji Mourad, Head of Global Partner Management at Envirotainer, said, ‘Swiss WorldCargo demonstrates their commitment to providing best-in-class services to their customers, and the pharmaceutical industry by promoting best practices and industry standards, such as the Qualified Envirotainer Provider (QEP) program. The commitment by teams on both sides is very encouraging and we expect such announcements to continue.’  

‘This is another very important milestone for Swiss WorldCargo on our pharma road-map,’ said Susanne Wellauer, Head of Vertical Industry Pharmaceutical and Healthcare. ‘It clearly shows the expertise of our teams and our ability to handle Envirotainer shipments in accordance with the industry standard Goods Distribution Practice. The QEP expert level of our Zurich hub is a clear evidence of our premium SWISS quality that extends through the whole Swiss WorldCargo network of 31 QEP advanced stations.’

Envirotainer launched the award-winning QEP program over 10 years ago to promote the safe handling of pharmaceuticals. QEP has led the way for other pharmaceutical handling certification programs and has, with approximately 40 participating companies, educated tens of thousands of individuals at more than 730 participating stations across the world. The effect has been to promote strong distribution practices and standardize the safe handling of Envirotainer containers.

‘The QEP program and its participants serve to protect the safe delivery of Pharmaceuticals for the benefit of the patient,’ said Chris Fore, Compliance Manager at Envirotainer. ‘QEP is both a benchmark and a means by which we engage our partners to provide consistent service and fulfill Good Distribution Practice requirements from Pharmaceutical companies. It helps pharmaceutical companies identify potential hazards and control the subsequent risks.’

Swiss WorldCargo is the airfreight division of Swiss International Air Lines (SWISS). Headquartered at Zurich Airport, Swiss WorldCargo offers a comprehensive range of logistics solutions for transporting high-value and care-intensive consignments to some 130 destinations in over 84 countries. The extensive Swiss WorldCargo network of airfreight services is further supplemented by daily truck connections between key business centers. 

As a reliable and innovative service provider within the Lufthansa Group, Swiss WorldCargo is consistently committed to delivering Swiss quality to its airfreight customers, and makes a substantial contribution to SWISS”s overall profitability.

Contact information SwissCargo:
Alexandra Dahl 
Senior Manager
Head of Cargo Marketing and Communications
Phone +41-44-564-42-58

Fabian Mettler
Cargo Communications Executive
Phone +41-44-564-47-54 

Contact information Envirotainer:
Bourji Mourad
Head of Global Partner Management,

Mattias Isaksson
Head of Marketing & Communications
Envirotainer AB

This information was brought to you by Cision,c2541616

The following files are available for download:


WASHINGTON, June 7, 2018 /PRNewswire/ —

Read Full Article

The Epitomee Capsule is designed to induce weight loss and improve glycemic control in overweight and obese patients

The Epitomee concept for weight loss and glycemic control was presented by the company”s CEO, Dr. Dan Hashimshony at the Mixii BioMed 2018 conference in Tel Aviv.  

‘The Epitomee shapeshifting™ capsule was designed with particular focus on the high prevalence of overweight and obese people. Our self-administered capsule can be used by the billions of people around the world who need assistance in their weight loss and and glycemic control efforts. Any solution that requires significant medical intervention such as a surgical or endoscopic procedure may be effective for some patients, but is not practical for the huge number of patients around the world in need of treatment,’ said Hashimshony. ‘Our shapeshifting capsule concept is different; it is self-administered, can be taken at home and triggers early satiety signals assisting in earlier termination of each meal, weight loss and better glycemic control.’

‘Preliminary clinical results from the Epitomee Capsule are very promising,’ said Prof. Shirin, the director of the Institute of Gastroenterology, Liver Diseases and Nutrition at the Assaf Harofeh Medical Center in Israel. ‘This self-administered concept of the Epitomee capsule could represent a new direction in the way we treat overweight and obesity.’

Dr. Shimon Eckhouse, Epitomee co-founder and chairman of the board said: ‘Our Shapeshaping™ capsule represents a new and very practical approach to the global over weight and obesity epidemic. Our clinical work indicates a great combination of a very simple, at home administration, a high degree of safety and very good effectiveness.’

About Epitomee Medical  

Epitomee was cofounded by Dr. Shimon Eckhouse with the goal of developing ingestible devices to treat some of today”s most prevalent underlying chronic diseases in a self-managed, safe, and effective way. Epitomee”s product is a drug-free, self-administered capsule that helps to improve glycemic control and addresses excess weight and obesity co-morbidities by promoting weight loss and establishing a healthier lifestyle.

The company is privately held with offices in Caesarea, Israel. For more information, please visit

CAESAREA, Israel, May 29, 2018 /PRNewswire/ —

Read Full Article

  • The studies carried out with tivanisiran showed an improvement in the inflammatory ocular parameters, tear quality, and a reduction in ocular pain, that is associated with dry eye syndrome[i]

Sylentis, Pharmaceutical Company belonging to the PharmaMar Group, has presented results from the clinical studies carried out with tivanisiran for the treatment of dry eye syndrome and that has enabled the start-up of the Phase III ‘Helix’ clinical trial. The presentation has taken place within the framework of the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) that has been held from the 29th of April to the 3rd of May in Honolulu, Hawaii.

     (Logo: )

The purpose if this meeting is to share the latest breakthroughs in research in the area of ophthalmology, to contribute to the progress in basic science and also in cutting-edge clinical research. In this context, Sylentis has participated at this event presenting the pre-clinical and clinical results of various compounds that are being developed for the treatment of ocular disorders. Among these, the abstract Tivanisiran a new treatment for Dry Eye Disease, that improved signs and symptoms in clinical trials (Posterboard number: 925 – B0103) is highlighted, the compound improving the ocular inflammatory parameters, tear quality and a reduction in ocular pain associated with dry eye disease is also underlined[1].    

The novel mechanism of action of tivanisiran, based on genetic silencing through RNA interference (RNAi), is targeted at the treatment of the signs and symptoms of this pathology, making it a firm candidate for the treatment of dry eye disease.

According to Ana Isabel Jiménez, Director of R&D at Sylentis, ‘We trust in our technology, innovative in this field, and we hope that tivanisiran will soon become a real alternative for the treatment of millions of people that suffer dry eye disease around the world.

In this respect, Jiménez points out that, ‘This is a significant step forward in the development of innovative drugs in different therapeutic areas through a novel technology of genetic silencing based on the RNA.

Sylentis is a pioneer in RNAi research, and is one of the few in Europe that applies this technology to the field of ophthalmology. It also continues with its research on new therapies for ophthalmological and inflammatory illnesses.

It must be empathized that this pathology affects more than five million in Spain, between 10% and 20% of the population, mostly women, and almost 100% of these being elderly[ii],[iii]. In this context, the phase III ‘Helix’ study is being carried out in more than 30 hospitals in Spain, Germany, Estonia, Portugal, Slovakia and Italy, in 300 patients to evaluate the efficacy of this compound in the treatment of the sign and symptoms of dry eye syndrome[iv].

About RNA interference

About tivanisiran (SYL1001)  

Tivanisiran is a drug based on RNAi that is administered as preservative-free eye drops; it selectively inhibits production of the transient receptor potential cation channel (TRPV1). These receptors are ion channels that mediate the transmission of ocular pain. Tivanisiran is a small synthetic double-stranded RNA oligonucleotide (siRNA) with a novel and highly selective mechanism of action. Non-clinical studies conducted by Sylentis with SYL1001 have demonstrated it has high ability to inhibit this specific target and block the perception of ocular pain in animals[3].

Tivanisiran is a product under development for the treatment of signs and symptoms related to dry eye syndrome and has the potential to be developed for other pathologies that cause ocular pain (corneal lesions, refractive surgery, etc.)[v],[vi],[vii].

About RNA interference (RNAi) 

RNA interference (RNAi) is a natural cellular process that regulates the expression of certain genes, providing a role in innate defense and development in animals and plants. This process is used to specifically silence genetic transcripts that encode protein-causing diseases. The therapeutic application of targeted siRNAs is booming given the specificity of gene silencing for a particular protein in a given tissue and the lack of side effects. This new approach to drug discovery is a promising technology that is rapidly moving in the translational research space[viii],[ix].

About dry eye syndrome 

Dry eye syndrome is a multifactorial disease of the tear film and ocular surface that produces symptoms of ocular discomfort, eyesight disorders, and tear film instability with potential damage to the ocular surface. Dry eye syndrome is accompanied by such symptoms as ocular pain, itching, stinging, and irritation of the eye tissues. It is a characteristic disease of developed countries, associated with pollution, air conditioning, the use of contact lenses, refractive surgery and continued use of computers. Moreover, the amount and quality of tears decrease with age. Prevalence is between 10% and 20% among people aged 50 or over, and it is more frequent in women[i],[ii].

Dry eye can be treated with cyclosporin drops or autologous serum, but there is as yet no specific product for chronic treatment of the ocular pain related to dry eye syndrome; oral analgesics or anaesthetics are used in general. However, the main treatment consists of artificial tears, in the form of drops, gel or creams. Preservative-free eye drops have generally been found to offer the best long-term response.

About Sylentis 
Sylentis, a company of PharmaMar (MCE: PHM), is a biotechnology company fully owned that develops innovative therapies harnessing the technology of post-transcriptional gene silencing or RNA interference (RNAi). Sylentis has developed an approach to efficiently design RNAi-based therapeutics that can be used to silence numerous disease-causing genes. We currently have a robust therapeutic program in ophthalmology with two candidates under development in Phase II  and III studies for glaucoma (bamosiran)[x] and ocular pain (SYL1001)[xi], respectively. Sylentis is also developing new products for the treatment of several eye diseases such as ocular allergies and retina diseases. To know more about us, please visit us at

i. April, 2018

ii. (April, 2018)

iii. Craig, J.P., et al., Tear Film & Ocular Surface Society [ ]. International Dry Eye WorkShop DEWS II Definition and Classification Report. Ocul Surf, 2017: p. 269-649.

iv. Benítez-Del Castillo JM, Protocol No.: SYL1001_IV. EUDRACT No: 2016-003903-79. A double-masked study of SYL1001 in patients with moderate to severe dry eye disease (DED). HELIX Study (Phase III). Version 1.1: December 14th, 2016. Sylentis SAU-Pharma Mar Group

v. Martinez-Garcia C, Martinez T, Pañeda C, Gallego P, Jimenez AI, Merayo J. Differential expression and localization of transient receptor potential vanilloid 1 in rabbit and human eyes. Histol Histopathol, 2013, 28(11):1507-16

vi. Martinez T, Gonzalez MV, Vargas B, Jimenez AI, Pañeda C. Preclinical Development of RNAi-Inducing Oligonucleotide Therapeutics for Eye Diseases. In RNA interference. ISBN: 978-953-51-4614-8. Ed. Intech. 2015

vii. Benitez-Del-Castillo JM, Moreno-Montañés J, Jimenez-Alfaro I, Muñoz-Negrete FJ, Turman K, Palumaa k, Sádaba B, Gonzalez MV, Ruz V, Vargas B, Pañeda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering for the treatment of Drye Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454

viii. Elbashir SM1, Harborth J, Lendeckel W, Yalcin A, Weber K, Tuschl T. Duplexes of 21-nucleotide RNAs mediate RNA interference in cultured mammalian cells. Nature. 2001 May 24;411(6836):494-8

ix. Soutschek J1, Akinc A, Bramlage B, Charisse K, Constien R, Donoghue M, Elbashir S, Geick A, Hadwiger P, Harborth J, John M, Kesavan V, Lavine G, Pandey RK, Racie T, Rajeev KG, Röhl J, Toudjarska I, Wang G, Wuschko S, Bumcrot D, Koteliansky V, Limmer S, Manoharan M, Vornlocher HP. Therapeutic silencing of an endogenous gene by systemic administration of modified siRNAs. Nature. 2004 Nov 11;432(7014):173-8

x. Moreno-Montañes J, Sádaba B, Ruz V, Gomez-Guiu A, Zarranz J, Gonzalez MV, Pañeda C, Jimenez AI. Phase I Clinical Trial of SYL040012, A Small Interfering RNA Targeting β-Adrenergic Receptor 2, for Lowering Intraocular Pressure. Mol Ther. 2014, 22(1):226-32

xi. (April, 2018)

Media Relations (+34-638-79-62-15) and Investor Relations (+34-914-444-500)

MADRID, May 3, 2018 /PRNewswire/ —

Read Full Article

INSPIRING study results contribute to the extensive body of evidence for dolutegravir, the leading integrase strand transfer inhibitor, in diverse and hard to treat patient populations

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced interim (Week 24) study results from INSPIRING, a phase IIIb study evaluating the safety and efficacy of dolutegravir in antiretroviral treatment-naive (ART-naïve) adults with HIV, co-infected with tuberculosis (TB). Results presented today at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, show that dolutegravir when administered at 50mg twice-daily with dual nucleoside reverse transcriptase inhibitors (NRTI), was effective and well-tolerated in HIV/TB co-infected adults receiving rifampin-based TB therapy.[1]

     (Logo: )

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, said, ‘Tuberculosis remains the leading cause of death among people living with HIV, accounting for around one in three AIDS-related deaths. Concurrent treatment of TB and HIV remains a challenge as it is compounded by drug interactions, overlapping toxicities and immune reconstitution inflammatory syndrome. This is why the INSPIRING study is so important, as we look to provide this underserved population with as many effective treatment options as possible. The INSPIRING results add to the breadth and depth of data available for dolutegravir and support its use in the treatment of people living with HIV co-infected with TB.’

INSPIRING is a phase IIIb, non-comparative, active control, randomised, open-label study in HIV-1 infected ART-naive adults with drug-sensitive TB. Of the 113 enrolled participants on a rifampin-based TB treatment for up to 8 weeks, 69 were randomised to receive dolutegravir (50mg twice-daily during and for two weeks after TB therapy followed by 50mg once-daily) with two NRTIs and 44 to receive efavirenz (600mg once-daily) with two NRTIs. The primary endpoint of the study is the proportion of dolutegravir patients with HIV-1 RNA <50 copies per mL at week 48.[1] The study, being conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa and Thailand, was not powered to show a difference between study arms and no formal statistical hypothesis was tested.

An interim analysis conducted at 24 weeks showed that the proportion of patients who maintained viral suppression (HIV-1 RNA less than 50 copies per ml) in the dolutegravir arm was 56/69 (81%) (95% confidence interval CI: 72%, 90%).[1] In the efavirenz arm, 39/44 patients (89%) (95% CI: 79%, 98%) maintained viral suppression. No patients in the dolutegravir arm and two patients in the efavirenz arm discontinued due to adverse events, while five participants (7%) in the dolutegravir arm and none in the efavirenz arm discontinued due to non-treatment related reasons (loss to follow-up/protocol deviations).[1] TB-associated immune reconstitution inflammatory syndrome (IRIS) rates were low in both arms (dolutegravir, n=4; efavirenz n=4) with no patients discontinuing due to IRIS or liver events.[1] The INSPIRING study is ongoing and 48-week data will be presented at a future scientific meeting.

In 2016, there were an estimated 10.4 million cases of TB globally, including 1.2 million (11%) among people living with HIV (PLHIV).[2] Although TB-related deaths among PLHIV have been steadily declining (33% decrease between 2005 and 2015), almost 60% of TB cases among PLHIV were not diagnosed or treated, resulting in 390,000 tuberculosis-related deaths among PLHIV in 2015.[2]

Notes to editors 

About HIV 

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.  

HIV has largely become a chronic treatable disease, with improved access to antiretroviral treatment leading to a 22% drop in global HIV mortality between 2009 and 2013, but more can be done for the estimated 36.7 million people living with HIV and 1.8 million individuals newly infected each year worldwide.[3]


INSPIRING is a phase IIIb, randomised, open-label, multicentre, parallel-group study to assess the antiviral activity of dolutegravir or efavirenz-containing regimens in HIV/TB co-infected patients undergoing rifampin-based TB therapy. The study includes a screening period, a randomised phase (Day 1 to 48 weeks plus a 4-week extension) and a dolutegravir open-label extension. During the dolutegravir open-label extension, patients were provided with dolutegravir until it is locally approved and commercially available, the patient no longer derives clinical benefit, or the patient meets a protocol-defined reason for discontinuation, whichever comes first.

The primary endpoint is the proportion of dolutegravir patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary endpoints include the proportion of efavirenz patients with plasma HIV-1 RNA <50 c/mL at Week 48 and evaluation of both study arms at Week 24. Additional secondary endpoints include evaluation of the development of viral resistance, measurements of safety, tolerability and changes from baseline CD4+ counts.

About Tivicay (dolutegravir)  

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

TIVICAY (dolutegravir) tablets  

Professional Indication(s) and Important Safety Information 

Indications and Usage 

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with:

  • other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg
  • rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies per mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent

Important Safety Information 


TIVICAY is contraindicated in patients:

  • with previous hypersensitivity reaction to dolutegravir
  • receiving dofetilide (antiarrhythmic)


Hypersensitivity Reactions: 

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY in Phase 3 clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected


  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Cases of hepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure, have also been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine)
  • Monitoring for hepatotoxicity is recommended

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: 

The concomitant use of TIVICAY and other drugs may result in known or potentially significant drug interactions (see Contraindications or Drug Interactions).

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.


The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment-naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%), fatigue (2%), and headache (2%).  


  • Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY
  • Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food
  • Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments



There are insufficient human data on the use of TIVICAY during pregnancy to inform a drug-associated risk of birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.


Breastfeeding is not recommended due to the potential for HIV transmission and developing viral resistance in HIV-positive infants.

Paediatric Use:  

Safety and efficacy of TIVICAY have not been established in paediatric patients weighing less than 30 kg or in any paediatric patients who are INSTI-experienced.

About ViiV Healthcare 

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company”s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit

About GSK 

GSK – one of the world”s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ”Principal risks and uncertainties” in the company”s Annual Report on Form 20-F for 2016.


1. Dooley KE, et al. Safety and efficacy of dolutegravir-based ART in TB/HIV co-infected adults at week 24. Presented at the Conference on Retroviruses and Opportunistic Infections, 2018. Boston, MA 

2. World Health Organization. Global Tuberculosis Report. 2017 

3. World Health Organization. HIV/AIDS Fact Sheet. Available at: . Last accessed November 2017.

LONDON, March 5, 2018 /PRNewswire/ —

Read Full Article