Biotechnology News

pharma-cancer-012417.jpg Consuming starchy foods that are cooked for long periods at high temperatures increases the risk of cancer, warns the Food Standards Agency in the UK.
Gilead Sciences, Inc. (GILD) announced Friday that the European Medicines Agency has validated its Marketing Authorization Application or MAA for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). The MAA for the investigational, once-daily, single tablet...
Synergy Pharmaceuticals Inc. (SGYP) said that the U.S. Food and Drug Administration has approved Trulance or plecanatide for the treatment of adults with chronic idiopathic constipation or CIC. Trulance will be available in the U.S. later this quarter. SGYP closed Thursday's regular trading at $6.41,...
Pharma-012017.jpg Shares of Synergy Pharmaceuticals Inc. (SGYP) were up over 5% in extended trading on Thursday, following FDA approval of TRULANCE for the treatment of adults with chronic idiopathic constipation.
pharma-011717.jpg Dermira Inc.'s (DERM) third and final phase III trial of Cimzia in adult patients with moderate-to-severe chronic plaque psoriasis has also met the key goals.
pharma-011817.jpg Alcobra Ltd.'s (ADHD) second phase III clinical trial of its investigational product Metadoxine Extended Release for the treatment of attention deficit hyperactivity disorder in adult patients has failed to meet the primary endpoint.


Tupperware U.S. Inc. of Orlando, Florida, is voluntarily recalling Southwest Chipotle Seasoning due to potential contamination with the deadly Salmonella bacteria. The recall has been initiated after the FDA found traces of Salmonella at a third party's facility where buttermilk powder, one ingredient in the seasoning mix, was manufactured.


Ultimate Body-Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules, marketed as dietary supplement for weight loss, as they contain undeclared Sibutramine.

Date Company Name Ticker Drug Event Outcome Details
07/21/2017 Puma Biotechnology Inc. PBYI PB272 (Neratinib) (NDA) FDA decision on PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer
07/19/2017 Amgen Inc. AMGN Romosozumab (BLA) FDA decision on Romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture
06/30/2017 Array BioPharma Inc. ARRY Binimetinib (NDA) FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
06/30/2017 Tesaro Inc. TSRO Niraparib (NDA) FDA decision on Niraparib a treatment for patients with recurrent epithelial ovarian for treatment of fallopian tube, or primary peritoneal cancer
06/24/2017 Portola Pharmaceuticals Inc. PTLA Betrixaban (NDA) FDA decision on Betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Results Date Company Name Ticker Event Indication Outcome
Q2 2017 ARCA biopharma, Inc. ABIO Interim analysis of phase 2b efficacy data of Gencaro (GENETIC-AF) Atrial Fibrillation
Q2 2017 CAPRICOR THERAPEUTICS, INC. CAPR 6-month topline data from Phase I/II trial of CAP-1002 (HOPE) Duchenne muscular dystrophy
Q2 2017 Paratek Pharmaceuticals, Inc. PRTK Top-line data of Phase 3 study of Omadacycline Community Acquired Bacterial Pneumonia (CABP)
Q2 2017 Aerie Pharmaceuticals, Inc. AERI Topline 90-day efficacy data from 2nd phase 3 trial of Roclatan (Mercury 2) To lower intraocular pressure in patients with glaucoma
Q2 2017 Galapagos NV.. GLPG Topline data from phase 2a study of GLPG1690 (FLORA) Idiopathic pulmonary fibrosis
Zynerba Pharmaceuticals, Inc. (ZYNE) has offered to sell 2.8 million shares of its common stock at $18.00 per share, with expected gross proceeds of $50.4 million. Zynerba also granted the underwriters a 30-day option to purchase up to 420,000 additional common shares. The offering is expected to close...
Mirati Therapeutics Inc. (MRTX) has offered to sell 4.35 million shares of its common stock to the public at a price of $5.60 each. The gross proceeds from the offering are expected to be about $65.0 million, and is scheduled to close on or about January 11, 2017.