Silvergate gets FDA nod for pediatric pJIA, ALL drug | Flex's IND for ALS drug wins FDA nod | Novartis, Amgen modify migraine drug collaboration
April 27, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Silvergate gets FDA nod for pediatric pJIA, ALL drug
The FDA has approved Silvergate's Xatmep, or methotrexate, oral solution indicated for treatment of acute lymphoblastic leukemia as part of multiphase combination chemotherapy maintenance in pediatric patients. Xatmep is also approved for the management of polyarticular juvenile idiopathic arthritis in patients who cannot use first-line therapies because they did not respond adequately to or cannot tolerate the treatment. (4/26) 
Flex's IND for ALS drug wins FDA nod
Flex Pharma's investigational new drug application for FLX-787 has received FDA approval for a midstage trial involving patients with amyotrophic lateral sclerosis. The company is also exploring use of the drug for treatment of the Charcot-Marie-Tooth group of neuropathies.
Seeking Alpha (free registration) (4/26) 
Novartis, Amgen modify migraine drug collaboration
Under a revised collaboration, Novartis will exclusively commercialize the migraine drug erenumab, or AMG 334, in Canada and in partnership with Amgen in the US. The human monoclonal antibody is thought to be the most developed of an emerging class of drugs targeting a receptor associated with migraine pain.
Genetic Engineering & Biotechnology News (4/26) 
FDA OKs Medicines Co., Alnylam's late-stage trial for inclisiran
Alnylam Pharmaceuticals and The Medicines Co. announced the FDA approved a late-stage clinical trial for inclisiran that will include patients with familial hypercholesterolemia and atherosclerotic cardiovascular disease. The filing of a new-drug application is anticipated by the end of 2019.
Reuters (4/26),  Seeking Alpha (free registration) (4/26) 
Real-world data support early treatment with MS drugs, Biogen reports
New real-world data presented by Biogen at the American Academy of Neurology meeting suggests early treatment with Tysabri, or natalizumab, and Tecfidera, or dimethyl fumarate, may benefit people with relapsing multiple sclerosis. (India) (4/26) 
Reimagine the life science patient experience
The life science industry is undergoing rapid transformation, driven by consumer empowerment, clinical innovation and outcomes-driven health care policy. In this changing landscape, medical device and pharmaceutical companies are striving to connect with patients and deliver the best possible experience before, during and after therapy. Learn more.
Global Focus
Shire's hypoparathyroidism treatment gets EU approval
Conditional marketing authorization has been granted by the European Commission to Shire's Natpar, or rhPTH[1-84], a full-length recombinant human parathyroid hormone used as an adjunctive treatment for chronic hypoparathyroidism in adults whose serum calcium levels are insufficiently managed with calcium and vitamin D. The approval was based on late-stage trial data.
Genetic Engineering & Biotechnology News (4/26) 
EMA grants PRIME status to uniQure's hemophilia B drug
The European Medicines Agency has granted priority medicines designation to uniQure's AMT-060, an investigational gene therapy for patients with hemophilia B. The designation was based on early-stage trial data showing patients with severe disease were nearly cured of spontaneous bleeding episodes with up to a year of follow-up, and they experienced significantly increased levels of Factor IX and substantially reduced need for Factor IX replacement.
PharmaTimes (U.K.) (4/26) 
Food & Dietary Supplements
Ready-to-eat ham products recalled over listeria risk
A voluntary recall has been issued by Fineberg Packing involving 8,822 pounds of its ready-to-eat ham products after inspectors found they might be contaminated with Listeria monocytogenes. The recalled items are FINEBERG'S Finest Danish Brand BBQ Flavored Ham and Holly Brand hickory smoked fully cooked HAM, both bearing the establishment number EST. 428; the products were shipped to distributors in Tennessee, Arkansas and Mississippi.
Food Safety News (4/26),  WMC-TV (Memphis,Tenn.)/The Associated Press (4/26) 
Medical Devices
Bill would ease regulatory processes for device accessories, backers say
The Risk-Based Classification of Accessories Act was introduced in the House to streamline regulatory reviews of medical device accessories by enabling companies to recommend a product classification and authorizing the agency to efficiently reclassify existing accessories, among other provisions. "A tailored review approach for device accessories would improve FDA's efficiency and save the agency resources while ensuring patients continue to benefit from safe and effective medical technologies," AdvaMed President and CEO Scott Whitaker.
Modern Healthcare (tiered subscription model) (4/26) 
EU OKs Intuitive Surgical's da Vinci X system
European regulators have given Intuitive Surgical CE mark approval for its da Vinci X robotic-assisted surgical system, which enables focused-quadrant surgery and a lower price point than other da Vinci systems, the company said. The system comes with 3D digital optics and flexible port placement, as well as advanced tools from the company's Xi system. (Boston) (4/26) 
Food and Drug Law Institute Highlights
One week away: 2017 Annual Conference, May 4-5, Washington, D.C.
The Annual Conference provides a space where the food and drug law industry can network and learn from their peers in a relaxed environment conducive to making connections. Explore different viewpoints, shape policy, and advance understanding with more than 700 seasoned legal, regulatory, compliance, marketing, and management professionals. View the agenda.
New release available for pre-order! How to Comply with Drug CGMPs, 2nd edition
Current Good Manufacturing Practices (CGMPs) require complex compliance efforts throughout the product cycle. The risks associated with noncompliance are substantial. How to Comply with Drug CGMPs helps you master the governing principles and compliance standards for CGMPs. Pre-order now.
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