Industry News

CTD Holdings, Inc., a biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced its filing of a Clinical Trial Application with Sweden's Medical Products Agency. "This is another milestone step for our company as we continue to build our international clinical trial program of Trappsol ® Cyclo™ for the treatment of Niemann-Pick Type C disease," said N. Scott Fine, Chairman and CEO of CTD. ""/>
CTD Holdings Files Clinical Trial Application With Swedish Medical Products Agency to Continue Advancing Its Drug Development Program
MacroGenics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, and Takeda Pharmaceutical Company Limited today announced the conclusion of their License and Option Agreement for MGD010. MacroGenics has regained the worldwide rights to..."/>
Takeda and MacroGenics Announce the Conclusion of their MGD010 License and Option Agreement
West Pharmaceutical Services, Inc. today announced that the Company's Board of Directors elected Paolo Pucci to fill the vacancy following the retirement of Anthony Welters. Pucci, 54, is Chief Executive Officer of ArQule, Inc., a biopharmaceutical company engaged in the research and development of targeted therapeutics. Prior to his joining ArQule in 2008, Mr."/>
West Elects New Director and Announces Increase to Quarterly Dividend
ProMIS Neurosciences, Inc. today announced that the company will present at the 18 th Annual Rodman& Renshaw Global Investment Conference, sponsored by H.C. The conference is being held September 11-13, 2016, at Lotte New York Palace Hotel in New York City. Gene Williams, Executive Chairman of ProMIS, will provide a corporate overview and review product portfolio progress and development plans during the live presentation and will be available to..."/>
ProMIS Neurosciences to Present at Rodman & Renshaw 18th Annual Global Investment Conference
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, and SciClone Pharmaceuticals, Inc., a US-based China-focused specialty pharmaceutical company, announced today that the companies have entered into an exclusive license agreement granting rights to SciClone to develop, promote, market,..."/>
Soligenix and SciClone Establish Regional Licensing Agreement for SGX942, a Novel Product Candidate for Oral Mucositis
Novogen's lead development candidate, and is being developed as an intraperitoneal therapy for patients with ovarian cancer Investigational New Drug application is the key regulatory filing to initiate clinical trials in the United States First-in-human phase I study remains on track for initiation in 4 Q 2016, as per previous guidance. Australian oncology-focused biotechnology company Novogen Ltd today announced that it..."/>
US FDA Approves Investigational New Drug (IND) Application for Cantrixil(TM) (TRX-E-002-1) in Ovarian Cancer
Terumo Cardiovascular Group, a global leader in medical devices for cardiac and vascular surgery and subsidiary of Japan-based Terumo Corporation, and CytoSorbents Corporation, manufacturer of the CytoSorb ® extracorporeal blood purification adsorber that reduces excessive levels of inflammatory mediators in critically-ill and cardiac surgery patients, announced today that they have entered into a..."/>
Terumo Cardiovascular Group and CytoSorbents Announce CytoSorb Cardiac Surgery Partnership
Foamix Pharmaceuticals Ltd.,, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced the topline results of its Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. Statistically significant differences were demonstrated for improvement in the primary and..."/>
Foamix Announces Positive Topline Results from Phase 2 Trial Evaluating FMX-103 Topical Minocycline Foam for Moderate-to-Severe Papulopustular Rosacea
Summit Therapeutics plc, the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection, today launches www.utrophintrials.com as an online resource for the DMD community. This website is dedicated to providing up to date information on utrophin and Summit’ s utrophin modulator clinical trials.. Utrophin modulation has the potential to treat all patients with DMD,..."/>
Summit Launches Online Resource on Utrophin Modulation for the Duchenne Muscular Dystrophy Community
AxoGen, Inc., a global leader in innovative surgical solutions for peripheral nerve injuries, today announced its participation at the American Association of Oral and Maxillofacial Surgeons 98th Annual Meeting taking place in Las Vegas, Nevada from September 18-23, 2016.. The meeting will feature an AxoGen supported lecture and lab session, with additional sessions and poster presentations regarding the use of AxoGen products."/>
AxoGen, Inc. to Participate at the American Association of Oral and Maxillofacial Surgeons 98th Annual Meeting
Resverlogix Corp. is pleased to announce its participation in the following industry conferences in the month of September. Rodman& Renshaw 18th Annual Global Investment Conference. BioPharm America 9 th Annual International Partnering Conference."/>
Resverlogix Announces Participation in Upcoming Conferences
Resverlogix Corp. is pleased to announce its participation in the following industry conferences in the month of September. Rodman& Renshaw 18th Annual Global Investment Conference. BioPharm America 9 th Annual International Partnering Conference."/>
Resverlogix Announces Participation in Upcoming Conferences
Perrigo Company plc, making it one of the Company's largest shareholders. Starboard also announced that it has delivered a letter to Perrigo's Chief Executive Officer, John Hendrickson, and the Company's Board of Directors. The full text of the letter follows and may also be viewed by clicking the following link:..."/>
Starboard Discloses 4.6% Ownership in Perrigo and Delivers Letter to the CEO and Board of Directors
Athersys, Inc. announced today the successful completion of Japan’ s Pharmaceutical and Medical Devices Agency review of the Clinical Trial Notification, allowing the commencement by HEALIOS K.K. of a confirmatory clinical trial evaluating the safety and efficacy of administration of MultiStem ®, Athersys’ novel cell therapy product, for the treatment of ischemic stroke in Japan. In accordance with the regulatory system in Japan, a CTN is equivalent..."/>
Athersys Announces Acceptance by PMDA of Clinical Trial Notification in Japan for Treatment of Ischemic Stroke With MultiStem®
Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions today announced top-line results from a pharmacokinetic study demonstrating bioequivalence of OXAYDO ® tablets CII 15 mg to Roxicodone ® 15 mg dose. The full data will be submitted to the U.S. Food and Drug Administration as a supplemental new drug..."/>
Egalet Announces OXAYDO® Demonstrates Bioequivalence at 15 mg Dose
Sunesis Pharmaceuticals, Inc. today announced results from the Company’ s Phase 1 A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic and pharmacodynamic profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’ s 2nd International Conference on New Concepts in B-Cell..."/>
Sunesis Presents Dose Escalation Results from the Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK inhibitor SNS-062
ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, today announced that it has taken a major step forward in its pursuit of a potentially curative combination therapy for chronic hepatitis B. The Company presented new preclinical data profiling the robust anti-HBV activity of its potentially best-in-class cyclophilin inhibitor CRV431,..."/>
ContraVir Reports New CRV431 Data Highlighting Synergistic Activity with CMX157 Against Hepatitis B
Opthea Limited, a developer of novel biologic therapies for the treatment of eye diseases, today announced that data from its Phase 1 clinical trial of OPT-302 was presented at the European Society of Retina Specialists Congress on Saturday, 10th September 2016, in Copenhagen, Denmark. OPT-302 is Opthea's lead program, a novel VEGF-C/D' Trap' therapy for wet age-related macular degeneration. The presentation titled "A first-in-human Phase 1/ 2 a..."/>
Opthea's Phase 1 Data From Wet AMD Clinical Trial Presented at EURETINA Congress 2016
Amarin Corporation plc announced that, as expected, the independent data monitoring committee has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175- patient outcomes study is evaluating whether treatment with Vascepa ® reduces cardiovascular events in..."/>
Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee
Cancer Genetics, Inc., a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced that it has entered into definitive agreements with institutional investors for an offering of 2.75 million shares of common stock with gross proceeds of approximately $5.5 million in a registered direct offering. Concurrently in a private placement, for each share of common stock purchased by an investor, such investor will..."/>
Cancer Genetics Announces $5.5 Million Registered Direct Offering
AmpliPhi Biosciences Corporation, a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, announced the publication of data from a preclinical study conducted by its collaborators at the University of Leicester demonstrating the therapeutic and prophylactic efficacy of AmpliPhi’ s proprietary phage cocktail, in vitro and in vivo, for the treatment and prevention of Clostridium difficile..."/>
AmpliPhi Biosciences’ Bacteriophage Cocktail Shown to Prevent C. difficile Biofilm Formation and Reduce Colonization

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