Biotechnology News

The U.S. Food and Drug Administration said that it approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach,...
Bristol-Myers Squibb Co (BMY) on Friday said the U.S. Food and Drug Administration has approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. According to the company, Daklinza is the first drug that has demonstrated safety and efficacy to...
Sanofi (SNY) and Regeneron Pharmaceuticals Inc (REGN) on Friday said the U.S. Food and Drug Administration has approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Praluent...
Pharma0-072815.jpg Shares of AtriCure Inc. (ATRC) were up more than 5% in extended trading on Tuesday after the company, which reported solid results for the second quarter, boosted its revenue outlook for 2015.
Pharma-072315.jpg Eagle Pharmaceuticals Inc.'s (EGRX) New Drug Application for its novel ready-to-use Bivalirudin product ("RTU Bivalirudin") filed under 505(b)(2) regulatory pathway has been accepted for review by the FDA.
Biotechnology0-072815.jpg Shares of XOMA Corp. (XOMA) plunged more than 77% on Wednesday following the failure of a phase III study of Gevokizumab in patients with Behçet's disease uveitis, run by its partner Servier, to meet the primary endpoint.

Maya Overseas Foods Inc. of Maspeth, New York, is recalling roughly 8000 lbs. of Cashew Split due to potential Salmonella contamination.


Arthur Schuman Inc. of Fairfield, New Jersey is recalling 30,200 lbs. of Bella Rosa Grated Parmesan Cheese as it may contain undeclared egg allergen.


Walgreen Co. of Deerfield, Illinois is recalling Nice! Powdered Sugar Mini Donuts after consumer complaints alleging that mold was observed on some products.


Best Cash & Carry is voluntarily recalling its BEST BRAND GREEN RAISIN (Sunderkhani) as the product may contain undeclared sulfites. Packed in an un-coded, 7 oz. plastic bag, the recalled product was sold in New York, Connecticut and New Jersey.

Date Company Name Ticker Drug Event Outcome Details
10/27/2015 Amgen Inc. AMGN Talimogene laherparepvec (NDA) FDA decision on Talimogene laherparepvec for advanced melanoma
10/24/2015 MERRIMACK PHARMACEUTICALS, INC. MACK MM-398 (NDA) FDA decision on MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
10/21/2015 Relypsa Inc RLYP Patiromer for Oral Suspension (NDA) FDA decision on Patiromer for the treatment of hyperkalemia
10/02/2015 Merck & Co Inc. MRK Keytruda (sBLA) FDA decision on Keytruda for the treatment of patients with advanced non-small cell lung cancer
09/08/2015 Synageva BioPharma Corp. GEVA Kanuma (BLA) FDA decision on Kanuma for the treatment of lysosomal acid lipase deficiency
Results Date Company Name Ticker Event Indication Outcome
Mid 2015 Vical Inc. VICL Efficacy data from phase 1/2 trial of Vaxfectin(R)-formulated therapeutic vaccine Herpes simplex virus type 2 (HSV-2)
Mid 2015 Fate Therapeutics, Inc FATE Full data on primary efficacy endpoint from phase II study of PROHEMA Hematologic malignancies
Mid 2015 Celldex Therapeutics Inc. CLDX First interim analysis of phase III 3 Study of Rindopepimut Frontline Glioblastoma
Mid 2015 Fate Therapeutics, Inc FATE Full data on primary efficacy endpoint from phase II study of PROHEMA Hematologic malignancies in adult subjects undergoing double umbilical cord blood transplantation
Mid 2015 Trevena, Inc. TRVN Data from Phase 2b Study of TRV130 Acute Postoperative Pain
Biopharmaceutical company Ultragenyx Pharmaceutical, Inc. (RARE) announced the pricing of its underwritten public offering of 2.2 million shares of its common stock at a price to the public of $120 per share, before underwriting discounts. The company has also granted the underwriters of the offering...
According to a new study, many new mothers receive no advice from healthcare professionals at the hospital on how to place their infants for sleep, the best options for sleeping arrangements or breastfeeding. The study, published in the Journal of the American Academy of Pediatrics, showed about 20 percent of mothers got no advice from doctors on breastfeeding or how to position their baby.
High blood sugar associated with prediabetes may increase the risk for Alzheimer's disease, a new study suggests. The study, published online in JAMA Neurology, involved researchers conducting memory tests on 150 adults with no mental impairments, at average age of 61. The researchers also measured insulin resistance and had the participants undergo a PET brain scan.
Fiat Chrysler Automobiles (FCAU) on Friday has recalled about 1.4 million vehicles equipped with certain radios to update software after researchers were able to remotely hack into a Jeep. The company is already distributing software that insulates connected vehicles from remote manipulation, which,...