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.
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.
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.
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.
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.
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.
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.
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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.
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.
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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