FDA fast-tracks treatment for Alzheimer's from AstraZeneca, Lilly | Supernus' sNDA for Trokendi XR gains tentative FDA approval | BARDA to fund development of Regeneron's MERS treatment
August 23, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
FDA fast-tracks treatment for Alzheimer's from AstraZeneca, Lilly
The FDA has granted fast-track designation to Eli Lilly and Co. and AstraZeneca's AZD3293, an early Alzheimer's disease treatment that inhibits an enzyme involved in the accumulation of beta-amyloid, which causes the disease. The results of a Phase II/III study on the drug are expected by August 2019, and a second late-stage study will begin this quarter.
The Wall Street Journal (tiered subscription model) (8/22),  Seeking Alpha (free registration) (8/22) 
Supernus' sNDA for Trokendi XR gains tentative FDA approval
The FDA has granted tentative approval to Supernus' supplemental new drug application to expand the label for its epilepsy drug Trokendi XR, or topiramate extended-release capsules, to include migraine prophylaxis in adults. The final approval will be effective only after the drug's pediatric exclusivity ends on March 28, 2017.
eMPR.com (8/22) 
BARDA to fund development of Regeneron's MERS treatment
The Biomedical Advanced Research and Development Authority entered into an agreement with Regeneron Pharmaceuticals, which will study and manufacture two potential antibody therapies to prevent and treat Middle East respiratory syndrome. Under the terms of the deal, BARDA will provide as much as $8.9 million for packaging and labeling of the antibodies, regulatory submission and a clinical trial conducted by the NIH.
Genetic Engineering & Biotechnology News (8/22) 
AstraZeneca gives recommendations on PDUFA VI implementation plan
In a meeting between industry stakeholders and the FDA to discuss PDUFA VI performance and procedural goals, AstraZeneca executive Howard Hutchinson recommended that the agency conduct real-time and face-to-face interaction with drugmakers during pre-IND Type B and Type C meetings. Huchinson also suggested faster issuance of new and updated FDA guidelines regarding the review of combination products.
Regulatory Focus (8/22) 
How To Successfully Select An ERP System in Eight Simple Steps
If you're looking for your first ERP system or looking to upgrade from an existing system, the evaluation, selection and implementation process is a long-term strategic decision for your organization. To help you through the process, here are eight simple steps for a successful ERP system selection. Download the free white paper now.
Global Focus
EU approves Gilead's HIV PrEP treatment
The European Commission has granted marketing approval to Gilead Sciences' once-daily Truvada, or emtricitabine/tenofovir disoproxil, as pre-exposure prophylaxis for HIV-1 infection in adults for use along with safer-sex practices. The approval was based on positive results from two placebo-controlled trials.
Bidness Etc. (8/22) 
Puma's marketing application for breast cancer drug under EMA review
The European Medicines Agency has accepted for review Puma Biotechnology's marketing authorization application for PB272, or neratinib, as an extended adjunct treatment for HER2-positive early-stage breast cancer in patients who received Herceptin, or trastuzumab, as prior therapy. The drug was submitted for FDA approval in July.
BioCentury (8/22) 
Food & Dietary Supplements
Scallops linked to hepatitis A outbreak recalled in 3 states
Sea Port Products voluntarily recalled scallops that were produced Nov. 23-24, 2015, and distributed to restaurants and commercial groups in Hawaii, Nevada and California because they were linked to a hepatitis A outbreak that sickened at least 206 people. The FDA and CDC are assisting the Hawaii Department of Health, which discovered the outbreak, with the investigation.
CNN (8/22) 
Medical Devices
MRI-conditional implant from Cochlear wins FDA nod
The FDA has given Cochlear approval for its Nucleus implants for use in MRI fields of up to 3.0 tesla without the implants' magnets. The implants, with the use of the Cochlear Nucleus Implant Bandage and Splint Kit, are also approved for 1.5-tesla MRI with the magnets inside.
AuntMinnie.com (free registration) (8/22) 
FDA permits ImPACT to market devices for post-concussion cognitive testing
ImPACT Applications has obtained permission from the FDA to market its Immediate Post-Concussion Assessment and Cognitive Testing system and ImPACT Pediatric, which are intended for use in assessing cognitive function and symptoms after a head injury. The ImPACT system is designed for use in patients ages 12 to 59 years and runs on a laptop or desktop, while the ImPACT Pediatric is intended for patients ages 5 to 11 years and works on an iPad.
Medscape (free registration) (8/22),  eMPR.com (8/22) 
EU awards Dune Medical $3.4M grant for biopsy device development
The European Commission has given Dune Medical a grant worth about $3.4 million to develop a biopsy device that is based on radio frequency spectroscopy, a technology used in developing the company's MarginProbe for breast cancer detection after tumor removal. The company intends to use the grant to initially commercialize the device, which has a finished design, in Europe and then in the US.
MedCityNews.com (8/22) 
FDLI Items
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