Johnson & Johnson unit Janssen Biotech's Tremfya, or guselkumab, has been granted approval by the FDA as a treatment for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Mylan's trastuzumab, a generic version of Roche Holding's Herceptin indicated for treatment of breast cancer, has been unanimously recommended for approval by an FDA advisory committee. Regulatory authorities in Europe, Australia and Canada are also reviewing the drug.
Amgen's late-stage study to evaluate Kyprolis, or carfilzomib, in combination with lenalidomide and dexamethasone as a treatment for patients with relapsed multiple myeloma met its primary endpoint, extending survival by 7.9 months. Participants receiving Kyprolis experienced a decrease of 21% in mortality risk compared with patients treated only with lenalidomide and dexamethasone.
Two in-vivo gene-editing product candidates from Sangamo Therapeutics -- SB-318, intended to treat patients with mucopolysaccharidosis type I and SB-913, for the treatment of MPS II -- have been granted fast-track designations by the FDA. The company is recruiting patients for Phase I/II studies.
The House Energy and Commerce Health Subcommittee held a hearing on draft bills that would provide clarification on the information that can be included by medical device and drug makers in pre-FDA approval product communication and govern the discussion of off-label use. Subcommittee Chairman Rep. Michael Burgess, R-Texas, said the measures would provide "a targeted approach to addressing the problems presented by our outdated regulatory framework for medical product communication."
Germany said it will apply to have Bonn become host of the London-based European Medicines Agency following Brexit, adding that the city has "concentrated expertise and strong national partners [the EMA] can rely on." Germany joins the Netherlands, Spain, France, Finland and Denmark in competing to be the home of the EMA once Britain exits the European Union in 2019.
Follow-on offerings raised a total of $525 million for Amicus Therapeutics, Alder BioPharmaceuticals and Arena Pharmaceuticals. Amicus is on its way to submit a new-drug application for Fabry's disease drug migalastat, while Arena's pulmonary arterial hypertension drug ralinepag has met its primary endpoint in a midstage study.
Learn more about key policy issues affecting biotechnology in Washington, D.C., and state capitals around the country. With the unpredictability of the federal level coupled with the increasingly hostile state legislatures, it is vital that the biotechnology industry amplify its voice on the federal, state and local levels. Become an advocate for biotechnology by joining BIO Action today. Now, more than ever, we need your voice! Text BIO to 52886 or visit BIO's website.
BIO and other industry groups urged the USDA to revise a number of provisions proposed by the Animal and Plant Health Inspection Service, which assess biotech organisms to identify if they pose plant pest or noxious weed risks. BIO said APHIS' proposed ruling "would create two parallel regulatory systems to evaluate the same risk, under the same statutory authority, in potentially inconsistent ways."
Scientists from Rutgers University-New Brunswick and Michigan State University have developed ways to genetically engineer enzyme surfaces that bind less to cornstalks and other cellulosic biomass, which lowers enzyme costs in biofuels production. "The challenge is breaking down cellulose [plant] material, using enzymes, into sugars that can be fermented into ethanol," said researcher Shishir P. S. Chundawat.
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.
I am tomorrow, or some future day, what I establish today. I am today what I established yesterday -- or some previous day.
Harvey Spencer Lewis, writer
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