FDA, EMA, PMDA agree on antibiotic trial guidelines | Alembic's hypertension drug gets FDA approval | Epizyme's soft tissue sarcoma drug wins FDA orphan status
June 23, 2017
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FDA, EMA, PMDA agree on antibiotic trial guidelines
FDA, EMA, PMDA agree on antibiotic trial guidelines
(Joe Raedle/Getty Images)
The FDA, the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency agreed to align their requirements for antibiotic trials to help stimulate the development of new treatments.
In-Pharma Technologist (6/20) 
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Health Care & Policy
Alembic's hypertension drug gets FDA approval
Alembic Pharmaceuticals' abbreviated new drug application to market its Candesartan Cilexetil tablets, 32 mg, as a treatment for hypertension in children and adults as well as heart failure was approved by the FDA.
India Infoline (6/21) 
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Epizyme's soft tissue sarcoma drug wins FDA orphan status
Epizyme's tazemetostat has gained orphan drug status from the FDA to treat soft tissue sarcoma. Tazemetostat was previously developed as a treatment for patients with non-Hodgkin lymphoma as well as certain genetically defined solid tumors.
Seeking Alpha (free registration) (6/21) 
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Roche's user-friendly version of blood cancer drug Rituxan gains FDA approval
A new formulation of Roche Holding's blockbuster cancer drug Rituxan called Rituxan Hycela can now be given as a subcutaneous injection within a five- to seven-minute period, unlike previous versions of the drug, which require infusion. Rituxan Hycela was approved for the treatment of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and will be available to US patients in one to two weeks, according to Roche.
Reuters (6/22) 
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NSCLC combo drug from Novartis wins FDA approval
The FDA has approved Novartis' Tafinlar + Mekinist combination drug as a treatment for patients with BRAF V600E mutant metastatic non-small cell lung cancer.
Reuters (6/22) 
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FDA commissioner aims to speed orphan reviews, nix REMS abuse
FDA Commissioner Scott Gottlieb told a Senate panel that he intends to eliminate the backlog of requests for orphan-drug designations within 90 days, set a 90-day review target for new requests and issue guidance for designing adaptive clinical trials, among other goals. Gottlieb also said he wants to set consistent policy for preventing abuse of the risk evaluation and mitigation strategy program.
Regulatory Focus (6/20) 
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Company & Financial News
Sarepta, Genethon to research muscular dystrophy treatment
Sarepta Therapeutics and Genethon have agreed to conduct joint gene-therapy research into Duchenne muscular dystrophy, combining Sarepta's experience in Duchenne drug development with Genethon's expertise in gene therapy, according to Sarepta CEO Edward Kaye.
Rare Disease Report (6/21) 
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Biotech firm's IPO aims to raise funds for thrombocytopenia lead candidate
Dova Pharmaceuticals is ready for its initial public offering of approximately 4.1 million shares of common stock to fund development of its lead product candidate, avatrombopag, a platelet production stimulant for the treatment of thrombocytopenia. Dova intends to submit a US marketing application next quarter with the FDA.
Seeking Alpha (free registration) (6/21) 
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The Latest From BIO ...
Take action on key policy issues affecting biotechnology in Washington, D.C., and state capitals around the country. Become a biotechnology advocate by joining BIO Action. Now, more than ever, we need your voice! Text BIO to 52886 or visit the website.
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Food & Agriculture
First insect-resistant biotech RNAi crops win EPA approval
Four new corn rootworm-resistant biotech products that contain a plant-incorporated protectant named SmartStax PRO have been approved by the Environmental Protection Agency. Scientists harnessed the ribonucleic acid interference technology found in SmartStax PRO, which silences the activity of a gene crucial to the survival of corn rootworms.
Genetic Literacy Project (6/21) 
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Industrial & Environmental
Trump puts biofuel, agriculture in spotlight during Iowa visit
President Donald Trump discussed the future of agriculture and renewable fuels that will empower America's farmers during his visit to Iowa. "The president clearly understands the benefits of a healthy and robust ethanol industry, and recognizes the importance of both first-generation corn ethanol and emerging advanced biofuel technologies," said Renewable Fuels Association President and CEO Bob Dinneen.
AgWired (6/22) 
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News From BIO
Registration for BIO 2017 World Congress now open
The Biotechnology Innovation Organization (BIO) announced registration and housing are now open for the 2017 World Congress on Industrial Biotechnology. The conference will be held July 23-26, 2017, at the Palais des congres de Montreal in Montreal. Register now.
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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