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Eli Lilly and Co. (LLY) and Incyte Corporation (INCY) said that the U.S. Food and Drug Administration's Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis or RA for adult...
Pfizer Inc. (PFE) said that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration or FDA for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children aged 1 through 9 years. Pfizer...
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...
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pharma-042318.jpg Today's Daily Dose brings you news about Prothena pulling the plug on its AL amyloidosis drug candidate NEOD001; FDA panel thumbs up for lower dose of Baricitinib; imposition of FDA's partial hold on Epizyme's Tazemetostat program and FDA striking down Pfizer's Herceptin biosimilar.
pharma-daily-041918.jpg Today's Daily Dose brings you news about Fresenius Kabi walking out of the Akorn deal; settlement of the long-running trade secret misappropriation suit between Alnylam) and Dicerna, and Abeona's gene therapy program ABO-202 for the treatment of Batten Disease securing Orphan Drug Designation in the European Union.
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.
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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
10/20/2018 Regeneron Pharmaceuticals REGN DUPIXENT (sBLA) FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018 Sanofi SNYNF, SNY DUPIXENT (sBLA) FDA decision on DUPIXENT for moderate-to-severe asthma
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
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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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