Biotechnology News

The U.S. Food and Drug Administration said it approved Ocrevus or ocrelizumab to treat adult patients with relapsing forms of multiple sclerosis or MS and primary progressive multiple sclerosis or PPMS. Ocrevus is an intravenous infusion given by a health care professional. The FDA granted approval of...
NuVasive, Inc. (NUVA) announced U.S. FDA 510(k) clearance of the CoRoent Small Interbody System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. The company said this marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels....
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced that the U.S. Food and Drug Administration approved DUPIXENT or dupilumab Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis or AD whose disease is not adequately controlled...
Pharma-033017.jpg Roche's subcutaneous Rituximab co-formulated with Halozyme Therapeutics' Enhanze Technology has been unanimously recommended for approval by an FDA panel.
Pharma-032917.jpg The FDA has approved Roche's OCREVUS for relapsing and primary progressive forms of multiple sclerosis.
Pharma-032817.jpg The FDA has approved TESARO Inc.'s ZEJULA for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. The drug is expected to be launched in the U.S. in late April.


Envy Me announced the recall of LaBri's Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The FDA found it to contain the undeclared ingredient sibutramine, which is a controlled substance that was removed from the market in October 2010 for safety reason. FDA reports one adverse event reported in June 2016.

Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration approved OCREVUS or ocrelizumab as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive...


Pro Sports Club of Bellevue, WA announced the recall of 36,957 Yogurt Peanut Crunch bars because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). The company noted that no illnesses related to the consumption of the Yogurt Peanut Crunch Bars have been reported to date. E. coli O157:H7 causes a diarrheal illness often with bloody stools.


EuroCan Manufacturing announced the recall of Lot Number 84 consisting of its individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms, HoundsTooth and Mac's Choice Pig Ears as they have the potential to be contaminated with Salmonella. The company noted that the potential...

Date Company Name Ticker Drug Event Outcome Details
09/25/2017 Intellipharmaceutics International IPCI Rexista (NDA under 505(b)(2)) FDA decision on Rexista Rexista™, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation
09/03/2017 Mylan N.V. MYL MYL-1401O (BLA) FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
08/30/2017 Teva Pharmaceutical Industries Limited TEVA SD-809 (NDA) FDA decision on SD-809 for the treatment of tardive dyskinesia
08/30/2017 Celgene Corporation CELG Enasidenib (NDA) FDA decision on Enasidenib for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation
08/27/2017 Pfizer Inc. PFE Avelumab (BLA) FDA decision on Avelumab for treatment of metastatic urothelial carcinoma
Results Date Company Name Ticker Event Indication Outcome
Summer 2017 Recro Pharma Inc. REPH File NDA for IV Meloxicam Treatment of acute postoperative pain.
Jun 2017 Nektar Therapeutics NKTR Topline data from Amikacin Inhale Phase 3 Program gram-negative pneumonia
Jun 2017 Gemphire Therapeutics Inc. GEMP Topline results from phase 2b trial of Gemcabene (COBALT -1) homozygous familial hypercholesterolemia
Jun 2017 bluebird bio Inc. BLUE Early data from phase 3 trial of LentiGlobin drug product (HGB-207) Transfusion-Dependent Beta-Thalassemia
Mid 2017 AVEO Pharmaceuticals, Inc. AVEO Pre-planned futility analysis of phase 3 trial of Tivozanib (TIVO-3) Advanced renal cell carcinoma
REGENXBIO Inc. (RGNX) announced the pricing of an underwritten public offering of 3.70 million shares of its common stock at $20.50 per share. This offering is expected to close on March 27, 2017. The company expects gross proceeds from this offering to be approximately $75.85 million and has granted...
Aurinia Pharmaceuticals Inc. (AUPH) has offered to sell 22.30 million common shares to the public at a price of $6.75 per share.