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Alkermes plc (ALKS) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461. FDA's target action date for the ALKS 5461 NDA is January 31, 2019. ALKS 5461 is a novel, once-daily, oral investigational medicine for the adjunctive...
The U.S. Food and Drug Administration cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the...
fda-approved-march2018-040218.jpg Only two novel drugs were approved by the FDA in March compared to seven drug approvals in the same month last year. Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before. Trogarzo received green signal from the FDA on March 6, 2018, while Ilumya was approved by the FDA on March 20, 2018.
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pharma-april23to29-042018.jpg The biotech sector witnessed a couple of hurrahs and heartaches this week. Now, let's take a look at the pharma/biotech stocks and upcoming events to keep an ear out for in the coming week.
pharma-daily-041918.jpg Today's Daily Dose brings you news about Rigel Pharma's stock offering; FDA panel support for GW Pharma's New Drug Application for Epidiolex; FDA approval of expanded use of AstraZeneca's TAGRISSO and Argos' decision to pull the plug on its ADAPT phase III trial.
pharma-041318.jpg Today's Daily Dose brings you news about an agreement between Pfenex and China NT Pharma; Bristol-Myers' near-term regulatory catalyst; Eloxx Pharma's progress with cystic fibrosis drug candidate and FDA clearance of Cantel Medical's ADVANTAGE PLUS Pass-Thru automated endoscope reprocessor.
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NutriZone, LLC of Houston, Texas is recalling 4 different dietary supplements due to potential Salmonella contamination. FDA's routine sampling and testing by the FDA revealed the presence of Salmonella. The products subject to recall were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida,...

Target Corp. (TGT) is recalling an undetermined amount of frozen ready-to-eat and not-ready-to-eat meat and poultry products sold at a single Target store on Oahu located at 1450 Ala Moana Blvd., Honolulu, Hawaii. The products subject to recall were not held at an appropriate temperature and may be...

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that Sheboygan Falls, Wis. establishment Johnsonville, LLC is recalling approximately 109,603 pounds of smoked pork sausage products due to possible contamination with extraneous materials. This problem was discovered...

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that SMI Holdings, Inc., doing business as Stampede Meat, Inc., is recalling approximately 484,800 pounds of beef products due to potential Salmonella contamination. There have been no confirmed reports of adverse...

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Date Company Name Ticker Drug Event Outcome Details
10/05/2018 Verastem, Inc. VSTM Duvelisib (NDA) FDA decision on Duvelisib for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
09/29/2018 Antares Pharma Inc. ATRS XYOSTED injection(Resubmitted NDA) FDA decision on XYOSTED injection for adult men with testosterone deficiency
09/03/2018 Adamis Pharmaceuticals Corp ADMP Symjepi (sNDA) FDA decision on low dose Symjepi (0.15mg) for the emergency treatment of anaphylaxis
08/30/2018 Akcea Therapeutics Inc. AKCA Volanesorsen (NDA) FDA decision on Volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
08/28/2018 Tetraphase Pharmaceuticals TTPH Eravacycline (NDA) FDA decision on Eravacycline for the treatment of complicated intra-abdominal infections
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Results Date Company Name Ticker Event Indication Outcome
Q3 2018 Strongbridge Biopharma plc SBBP Topline data from Phase 3 study of COR-003 (LOGICS) endogenous Cushing's syndrome
2H 2018 BioLineRx Ltd. BLRX Topline results from phase 2a study of BL-8040 with Keytruda pancreatic cancer
2H 2018 ALDER BIOPHARMACEUTICALS INC ALDR Filing of a BLA with the FDA for Eptinezumab (formerly ALD 403) prevention of migraine
2H 2018 Conatus Pharmaceuticals Inc CNAT Results from Phase 2b trial of Emricasan (ENCORE-PH) Liver cirrhosis caused by nonalcoholic steatohepatitis
2H 2018 Endocyte, Inc. ECYT Updated results from Peter MacCallum Cancer Center-sponsored 177Lu-PSMA-617 trial Metastatic castration-resistant prostate cancer
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Shares of SIGA Technologies Inc. (SIGA) are up nearly 30 percent year-to-date while the iShares NASDAQ Biotechnology Index (ETF)(IBB) has returned a mere 0.5% during the same period.
Shares of Apellis Pharmaceuticals Inc. (APLS), which touched a new high of $29.34 on Wednesday, are up nearly 26% year-to-date while the iShares NASDAQ Biotechnology Index (ETF)(IBB) is down 1.3% for the same period.
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