Tag: FDA
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Hemophilia Therapy Candidate Given Breakthrough Status
4 September 2015. A synthetic antibody designed to prevent bleeding episodes among people with the most common type of hemophilia received a breakthrough therapy designation from the U.S. Food and Drug Administration. The pharmaceutical company Roche says FDA assigned the designation its biologic therapy code-named ACE910, now being tested in clinical trials. Hemophilia is an inherited…
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Preventive Drugs Found to Stop New HIV Infections
2 September 2015. A large-scale study of preexposure prophylaxis or PrEP, the use of antiviral drugs to prevent HIV infection, found the practice prevented new HIV infections among Kaiser Permanente clients in San Francisco over a 32-month period. Results of the study led by Kaiser Permanente epidemiologist Jonathan Volk, appear in yesterday’s issue of the…
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FDA Proposes Guidance, Rule on Biosimilar Naming
28 August 2015. The U.S. Food and Drug Administration proposed new guidance yesterday to provide a common, nonproprietary naming system for generic forms of biologic treatments, known as biosimilars. The agency also proposed a rule applying the system to six biologics and biosimilars already approved, announced with the guidance in a blog post on the…
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Peanut Allergy Therapy Company Raises $160 Million in IPO
6 August 2015. Aimmune Therapeutics Inc., a developer of treatments for peanut and other food allergies, raised $160 million from its initial public stock offering, pricing its 10 million shares at $16.00. Shares in the Brisbane, California company trade on the Nasdaq exchange under the symbol AIMT. Shares closed today (6 August), priced at $24.10…
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Pharma Licenses University Antibiotic Enhancements
5 August 2015. Technologies that remove side-effect causing toxicity from gentamicin, a powerful antibiotic drug, are being licensed from two universities by La Jolla Pharmaceutical Company. Financial terms of the agreements between the San Diego biopharmaceutical developer and University of Alabama in Birmingham and University of Indiana were not disclosed. Gentamicin is one of a…
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Opioid Overdose Nasal Spray Cleared for FDA Review
29 July 2015. Indivior plc, a pharmaceutical company in the U.K. specializing in addiction therapies, received notice that the U.S. Food and Drug Administration accepted the company’s new drug application and is beginning review of Indivior’s opioid overdose treatment formulated as a nasal spray. The FDA also granted Indivior, in Slough, U.K., priority review status…
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FDA Clears Trial of Fibrosis Drug for Muscular Dystrophy
24 July 2015. Biotechnology company Fibrogen Inc. says the U.S. Food and Drug Administration approved an application to test its fibrosis drug candidate in patients with Duchenne muscular dystrophy. The company says FDA’s approval was part of a new drug application for its candidate, code-named FG-3019, already in intermediate-stage clinical trials as a therapy for…
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Cancer Specialists Offer Plan to Reduce Drug Prices
23 July 2015. A group of 118 cancer specialists proposed steps to reduce the cost of drugs to cancer patients, calling the current system of drug pricing “unsustainable and not affordable for many patients.” Their recommendations appear today in a commentary published in the journal Mayo Clinic Proceedings. Pharmaceutical industry representatives, however, say drugs play…
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Cough Diagnostics Mobile App in Clinical Trial
22 July 2015. A smartphone app designed to diagnose the nature of a cough by the sound it makes is now being tested in a clinical trial in Australia. The app, developed in the lab of engineering professor Udantha Abeyratne at University of Queensland in Brisbane, Australia was licensed to a spin-off company from the…
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FDA Clears Biotech Cancer Therapies for Early Trials
13 July 2015. Biotechnology company Blueprint Medicines says U.S. Food and Drug Administration accepted new drug applications on its two lead products, clearing the way for trials with humans. The Cambridge, Massachusetts enterprise is developing cancer therapies, with its lead products targeting liver and gastrointestinal tumors. Blueprint develops cancer therapies that limit the actions of…