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The European Commission has granted a standard marketing authorization for FAMPYRA or prolonged-release fampridine tablets for walking improvement in people with multiple sclerosis or MS, Biogen (BIIB) announced today. The approval is based on the results of the Phase 3 ENHANCE study, which confirm the...
Merck (MRK) said that the U.S. Food and Drug Administration has approved a new indication for KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H)...
The U.S. Food and Drug Administration expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. Giant cell arteritis is a form of vasculitis, a group of...
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Pharma-052417.jpg Today's Daily Dose brings you news about FDA approval of Merck's Keytruda for yet another indication; Neurocrine's disappointing phase II study of Ingrezza in Tourette syndrome; Spring Bank's results from phase 2a segment of its ACHIEVE trial and Syndax' public offering.
pharma-051917.jpg Today's Daily Dose brings you news about the spike in Puma's shares ahead of FDA panel review; FDA approval of expanded indication of Roche's subcutaneous Actemra; FDA approval of Sanofi's Kevzara; upcoming catalyst of Spring Bank Pharma and secondary offering of GlycoMimetics.
GlycoMimetics-051917.jpg Shares of GlycoMimetics Inc. (GLYC) have exploded higher by more than 170% in the last 5 trading days in sharp contrast to the iShares NASDAQ Biotechnology Index (ETF), which is down 1.22% during the same period.
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Dynamic Technical Formulations LLC announced the voluntarily recall of all lots of Tri-Ton. The FDA's lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances. Use...

Smallbatch Pets Inc. of Portland, Oregon announced voluntarily recall of two lots of frozen 2lbs. chicken blend for dogs and cats, brand name Smallbatch, citing potential contamination of Salmonella. No pet or consumer illnesses from this product have been reported to date. This recall was initiated...

McCain Foods USA, Inc. announced voluntary recall of retail, frozen hash brown products that may be contaminated with extraneous golf ball materials, that may have been inadvertently harvested with potatoes used to make this product. Consumption of these products may pose a choking hazard or other...

Hummingbird Wholesale of Eugene, Oregon announced the recall of 5lbs of Organic Cocoa-Dusted Chocolate Ginger, because it may contain undeclared hazelnut. No illnesses have been reported to date. The recall was initiated after it was discovered that product containing Hazelnut was distributed in packaging...

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Date Company Name Ticker Drug Event Outcome Details
11/16/2017 Ultragenyx Pharmaceutical Inc RARE Recombinant human beta-glucuronidase (BLA) FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
10/30/2017 Eagle Pharmaceuticals Inc EGRX Pemetrexed Injection (NDA) FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
10/24/2017 PTC Therapeutics Inc. PTCT Translarna (NDA) FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/20/2017 Antares Pharma Inc. ATRS QuickShot Testosterone (NDA) FDA decision on QST as treatment for low testosterone associated with hypogonadism
10/12/2017 AcelRx Pharmaceuticals Inc. ACRX DSUVIA (NDA) FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
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Results Date Company Name Ticker Event Indication Outcome
2H 2017 ReGeneRx Biopharmaceuticals Inc RGRX.OB Topline data from U.S. Phase 3 trial of RGN-259 Neurotrophic keratopathy
Q3 2017 Versartis Inc. VSAR Topline data from Phase 3 Study of VRS-317 (VELOCITY) Growth Hormone Deficiency in children
2H 2017 Momenta Pharmaceuticals Inc MNTA Topline data from phase 2 study of M402 in combination with nab-Paclitaxel and Gemcitabine Metastatic Pancreatic Cancer Enrollment discontinued as interim futility analysis did not show a sufficient level of efficacy to warrant continued enrollment
2H 2017 Otonomy Inc. OTIC Results from phase 3 trial of OTO-104 (AVERTS-1) Ménière’s disease
2H 2017 Otonomy Inc. OTIC Results from phase 3 trial of OTO-104 (AVERTS-2) Ménière’s disease
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