Biotechnology News

Valeant Pharmaceuticals International (VRX, VRX.TO) announced the U.S. FDA has approved the Biologics License Application for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis. Valeant expects...
The U.S. Food and Drug Administration approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is marketed by Bridgewater, New Jersey-based Valeant Pharmaceuticals (VRX, VRX.TO). Siliq is intended for patients who are candidates...
The U.S. Food and Drug Administration approved Emflaza or deflazacort tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy or DMD, a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works...
Pulsebioscience-021717.jpg Shares of development-stage medical technology company Pulse Biosciences Inc. (PLSE) have gained nearly 30% so far this week.
pharma-021617.jpg Ardelyx Inc.'s (ARDX) phase III clinical trial of Tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis has met its primary endpoint and was generally well-tolerated.
pharma-021517.jpg Axsome Therapeutics Inc.'s (AXSM) drug candidate AXS-05 has received Fast Track status from the FDA for treatment resistant depression.


San Diego, CA-based Synergy Rx Pharmacy is voluntarily recalling the following non-sterile products; Sublingual Tablets, HCG and HCG with resveratrol Human Chorionic Gonadoptropin), Non Sterile Dermatology creams all strengths (retinoic acid creams, hydroquinine creams, bleaching creams), Numbing Creams,...


Dutch Valley Food Distributors, Schlabach branch issued a recall on various Cheeses and cheese containing items due to the potential for Listeria monocytogenes contamination. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others...

Veggie Noodle Co. of Austin, Texas is voluntarily recalling a limited quantity of Butternut Spirals due to possible contamination with Listeria monocytogenes. There are no reported illnesses associated with this recall to date. Listeria monocytogenes is an organism which can cause serious and sometimes...


NSE Products, Inc., a wholly owned subsidiary of Nu Skin Enterprises, Inc. (NUS), is recalling all ageLOC TR90 Protein Boost as it contains milk in the formula, which is not declared on the label. The recall was initiated after Nu Skin discovered that the flavoring used in the product contains buttermilk, which constitutes approximately 0.1 percent of the overall product formulation.

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 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
06/30/2017 Array BioPharma Inc. ARRY Binimetinib (NDA) FDA decision on Binimetinib for patients with NRAS-mutant melanoma.
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
Mid 2017 Karyopharm Therapeutics Inc. KPTI Topline data from phase 2 portion of phase 2/3 clinical trial with oral Selinexor (SEAL) Advanced unresectable dedifferentiated liposarcoma
Mid 2017 Tokai Pharmaceuticals Inc. TKAI Topline data from phase 3 registration clinical of Galeterone (ARMOR3-SV) Metastatic castration-resistant prostate cancer (mCRPC) Study discontinued as it is unlikely to meet endpoint; Stock down over 78% on Jul.26, 2016
Mid 2017 Karyopharm Therapeutics Inc. KPTI Top-line data from Phase 2 study of Selinexor (SOPRA study) Older patients with relapsed/refractory acute myeloid leukemia (AML)
Mid 2017 Supernus Pharmaceuticals, Inc. SUPN Data from phase 3 study of SPN-810 Impulsive Aggression in patients who have ADHD
Mid 2017 Cytori Therapeutics Inc. CYTX Data from phase 3 study of Cytori Cell Therapy (STAR) Impaired hand function from scleroderma
Neos Therapeutics, Inc. (NEOS) announced that it has priced the public offering of 5 million shares of its common stock at $5.00 per share for $25 million. The company expects this offering to close on February 8, 2017. In addition, Neos has granted the underwriters a 30-day option to purchase up...