Biotechnology News

Shares of Sensorion SA were gaining around 5 percent in Paris trading after the French biotech company focused on inner ear diseases, Tuesday said that the U.S. Food and Drug Administration has granted orphan drug designation to SENS-401. The company noted that SENS-401 is a therapy in development...
AstraZeneca and Merck & Co., Inc., (MRK) announced that the US Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA or olaparib, as follows: New use of LYNPARZA tablets as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube or...
Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration has approved Besponsa(inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia or ALL. BESPONSA was reviewed and approved under the FDA's Breakthrough Therapy designation...
Pharma-082317.jpg Today's Daily Dose brings you news about InspireMD's listing deficiency; MabVax's exploration of strategic alternatives; Novogen's progress in developing GDC-008 in glioblastoma; Psychemedics' launch of Synthetic Cannabinoids test and disappointing results from Ultragenyx's GNE Myopathy trial.
Pharma-082217.jpg Today's Daily Dose brings you news about European approval of Alexion's Soliris for an additional indication; Alkermes' New Drug Application for a major depressive disorder drug; Astellas' MORPHO trial progress; Axovant's move to NASDAQ from the Big Board; Cardiome's disappointing update related to its antiarrhythmic drug and FDA approval of Ironwood's gout drug.
anipharma-081817.jpg In today's Spotlight column, the company we are featuring is ANI Pharmaceuticals Inc. (ANIP).


The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Fair Oaks Farms, LLC is recalling approximately 1,134 pounds of pork sausage patties due to possible Listeria contamination. There have been no confirmed reports of adverse reactions due to consumption of these products.


The U.S. Food and Drug Administration issued warning to consumers on Longjack Coffee, in addition to other instant coffee products that have been recalled recently - Kopi Jantan Tradisional Natural Herbs Coffee, CaverFlo Coffee, and AMPT Coffee. These products, which are made in Malaysia, are promoted and sold online for sexual enhancement.


St Louis-based Dierbergs Markets announced recall of two Deli Products with multiple use by dates in all 25 retail stores due to the presence of undeclared fish (bonito, cod), undeclared lobster, crab, and shrimp in scampi butter and undeclared soy and wheat in cabernet grille butter. No illnesses have been reported to date in connection with this problem.


The distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Florida due to possible product contamination.

Date Company Name Ticker Drug Event Outcome Details
01/24/2018 Synergy Pharmaceuticals, Inc. SGYP TRULANCE (sNDA) FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
01/12/2018 Ligand Pharmaceuticals Inc LGND LUXTURNA (BLA) FDA decision on LUXTURNA for inherited retinal disease
01/10/2018 Eli Lilly And Co. LLY Abemaciclib (NDA) FDA decision on Abemaciclib for the treatment of advanced breast cancer
01/07/2018 Intersect ENT Inc XENT SINUVA implant (NDA) FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
12/30/2017 AEterna Zentaris Inc AEZ.TO, AEZS Macrilen (NDA resubmission) FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
Results Date Company Name Ticker Event Indication Outcome
Q4 2017 Vical Inc. VICL Topline data from phase 3 trial of ASP0113 CMV Vaccine Prevent cytomegalovirus in subjects undergoing allogeneic hematopoietic stem cell transplant
Q4 2017 StemCells Inc STEM Results from phase 2 study of HuCNS-SC (Pathway Study) Cervical spinal cord injury (cSCI) Terminates study; Co. to begin Orderly Wind Down of Operations
Q4 2017 EYEGATE PHARMACEUTICALS INC EYEG Topline data from confirmatory Phase 3 trial of EGP-437 combination product Non-infectious anterior uveitis;
Q4 2017 Aquinox Pharmaceuticals, Inc. AQXP Top-line data from first Phase 3 trial of AQX-1125 Interstitial cystitis/bladder pain syndrome
Q4 2017 Arena Pharmaceutical Inc. ARNA Data from phase 2 study of Etrasimod ulcerative colitis
MyoKardia, Inc. (MYOK) has offered to sell 3.50 million shares of its common stock to the public at a price of $35.50 each. The underwriters have a 30-day option to purchase up to an additional 525,000 shares of common stock in connection with the public offering. MyoKardia expects to use this offering...