Biotechnology News

Biopharmaceutical company NPS Pharmaceuticals Inc. (NPSP) announced that the U.S. Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara, a bioengineered replica of human...
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corp. (CELG), announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel)...
The Medicines Co. (MDCO) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued positive opinions recommending marketing authorization for three of its pipeline development candidates - Kengrexal (cangrelor), Orbactiv (oritavancin), and...
Pharma-012315.jpg Novo Nordisk A/S (NVO) has received positive opinion from the European regulatory authorities for Saxenda for the treatment of obesity as an adjunct to a reduced-calorie diet and increased physical activity.
Pharma-012215.jpg InspireMD Inc. (NSPR) has been issued a notice of delisting by the NYSE MKT LLC for failure to satisfy continued listing standards of the Exchange.
Pharma-011615.jpg PharmAthene Inc. has been awarded $194.6 million plus a post-judgment interest of $30,663.89 per day by the Delaware Court of Chancery in the company's litigation against SIGA Technologies Inc.


Innovative specialty food manufacturer Inventure Foods Inc. (SNAK) is recalling its Rader Farms Fresh Start Blends because of a potential to be contaminated with the deadly bacterium Listeria monocytogenes.

Full Tilt Ice Cream of Seattle, Washington is recalling all dairy based ice cream products except non-dairy frozen desserts because of possible contamination with the deadly bacterium Listeria monocytogenes.


Farm Country Cheese House, located in Lakeview, Michigan, is recalling 1136.53 pounds of Raw Milk Cheddar because of possible contamination with the deadly bacterium Listeria monocytogenes.


The FDA is warning consumers not to eat commercially-produced, prepackaged whole caramel apples until more specific guidance can be provided on the investigation of an outbreak of listeriosis linked to the product.

Date Company Name Ticker Drug Event Outcome Details
04/17/2015 Pharmacyclics Inc. PCYC IMBRUVICA (sNDA) FDA decision on IMBRUVICA as a treatment for patients with Waldenstrom's macroglobulinemia
04/13/2015 Pfizer Inc. PFE IBRANCE (NDA) FDA decision on IBRANCE for treatment of advanced breast cancer
04/13/2015 Pfizer Inc. PFE Palbociclib (NDA) FDA decision on Palbociclib as a first-line therapy in combination with Letrozole for ER+, HER2- advanced breast cancer
03/30/2015 Regeneron Pharmaceuticals REGN EYLEA (sBLA) FDA decision on EYLEA for diabetic retinopathy in patients with DME
03/17/2015 Vertex Pharmaceuticals Inc. VRTX Ivacaftor (NDA) FDA decision on Ivacaftor in children with CF ages 2 to 5 who have G551D or one of the 8 addnl.gating mutations
Submission Date Company Name Ticker Device Category Outcome Details
07/25/2014 Guided Therapeutics, Inc. GTHP.OB LuViva Advanced Cervical Scan. PMA (Amended)
04/07/2014 Myriad Genetics Inc. MYGN BRACAnalysis as a companion test PMA (First module)
04/01/2014 STEREOTAXIS INC STXS Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator 510(k)
02/18/2013 EXACT Sciences Corp. EXAS Second module for stool DNA colorectal cancer screening test PMA
12/07/2012 EXACT Sciences Corp. EXAS First module for stool DNA colorectal cancer screening test PMA
Intrexon Corp. (XON) is selling 3.75 million shares of its common stock to the public at a price of $27.00 each. The underwriters have a 30-day option to purchase up to an additional 562,500 shares of common stock offered in the public offering.
Keryx Biopharmaceuticals Inc. (KERX) has offered to sell 9.16 million shares of its common stock to the public at a price of $12.00 each.
Everyone knows that diet and exercise are essential to keeping a healthy body. Sometimes, though, dangerous obesity requires cultural or medical intervention. Here are 3 other recent events that are helping the fight against obesity.
Prostate cancer is one of the most dreaded forms of the disease - a major problem in men's health and in the medical community generally. Recent study results released by Medivation Inc. (MDVN) and Astellas Pharma showed that a mid-stage trial of an experimental drug showed some progress. Here a few advancements (and one step back) in the battle to alleviate prostate cancer.