FDA approves clinical trials of Alzheimer's/schizophrenia drug | Merck's Keytruda given FDA priority review for lung cancer | FDA fast-tracks Epizyme's lymphoma drug
November 29, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
FDA approves clinical trials of Alzheimer's/schizophrenia drug
clinical trial
(Indranil Mukherjee/AFP/Getty Images)
The FDA approved clinical trials of a compound for Alzheimer's disease and schizophrenia by the Vanderbilt Center for Neuroscience Drug Discovery. The academic center is taking a new step into clinical studies as pharmaceutical companies are reducing their backing of neuroscience research.
Chemical & Engineering News (11/28) 
Merck's Keytruda given FDA priority review for lung cancer
The FDA granted Merck & Co. priority review status for Keytruda as a first-line treatment for advanced non-small cell lung cancer with tumors that express PD-L1. Keytruda is approved to treat melanoma and is under study against more than 30 forms of cancer.
Investopedia (11/28) 
FDA fast-tracks Epizyme's lymphoma drug
Epizyme's tazemetostat has been granted fast-track designation by the FDA as a treatment for relapsed or refractory diffuse large B-cell lymphoma in patients with an EZH2-activating mutation. The drug is also being developed as a treatment for non-Hodgkin lymphoma and some genetically defined solid tumors.
Seeking Alpha (free registration) (11/28) 
FDA: Lupin may resume Goa drug production for US market
Lupin received an FDA establishment inspection report allowing it to resume drug production for the US market at its Goa, India, plant. The notification confirmed the resolution of issues raised by FDA inspectors in March.
InPharm.com (11/28) 
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Global Focus
GSK seeks EMA approval for shingles vaccine
A marketing authorization application has been submitted to the European Medicines Agency by GlaxoSmithKline for its shingles vaccine Shingrix. The filing was backed by late-stage study data that demonstrated the drug's ability to reduce the overall incidence of postherpetic neuralgia in addition to reducing the incidence of shingles.
PharmaTimes (U.K.) (11/28),  PharmaBiz.com (India) (11/28) 
Janssen files MAA to EMA for plaque psoriasis treatment
Janssen has filed a marketing authorization application with the European Medicines Agency for guselkumab as a treatment for moderate to severe plaque psoriasis in adults. The submission was supported by data from four studies that evaluated the safety and efficacy of the drug when administered by subcutaneous injection.
PharmaBiz.com (India) (11/28) 
EU grants conditional approval to Takeda's multiple myeloma treatment
Takeda Pharmaceutical's Ninlaro, or ixazomib, has received conditional approval from the European Commission for use along with lenalidomide and dexamethasone as a treatment for multiple myeloma in adult patients who have received at least one previous therapy. Late-stage study data showed the combination treatment improved median progression-free survival compared with only dexamethasone or lenalidomide.
OncLive (11/28) 
Food & Dietary Supplements
Calbee recalls snap pea crisps due to mislabeling, undeclared allergen
A total of 3,588 cases of Harvest Snap Black Pepper snap pea crisps are being recalled by Calbee because they may actually contain Harvest Snap Wasabi Ranch snap pea crisps that contain milk not declared on the label. The products being recalled are packed in 3.3-ounce bags, have the lot number MAR 31 17 0141 S and were sold Oct. 3-4 in Florida's Publix Super Market stores.
Food Poisoning Bulletin (11/28) 
Medical Devices
FDA OKs breast biopsy accessory from Dilon, GE Healthcare
The FDA has given Dilon Diagnostics and GE Healthcare approval for a molecular breast imaging localization accessory for breast biopsy, which is intended to complement GE's Discovery NM750b system. The accessory, designed to provide guidance for interventional applications, uses information from stereotactic pairs of two-dimensional images to precisely locate breast lesions in three dimensions.
Medical Devices Business Review (U.K.) (11/28) 
Medtronic issues safety notice on hemodialysis machines
An urgent field safety notice has been issued by Medtronic concerning three fires connected to its Formula hemodialysis machines, two of which were caused by issues with the device's battery charge board. The company said it is developing a permanent solution to correct the issue and recommended in the meantime that the battery charge board be disconnected.
MassDevice.com (Boston) (11/28) 
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