Biotechnology News

Mylan (MYL) announced the U.S. launch of Amlodipine and Valsartan Tablets, 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg, which is the generic version of Novartis' Exforge Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application...
Novartis (NVS) announced that the US Food and Drug Administration (FDA) has approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and...
French drug maker Sanofi's (SNY) unit Genzyme announced that the Ministry of Health, Labor and Welfare (MHLW) of Japan has granted marketing approval for Cerdelga (eliglustat) as the only oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. The MHLW approval was based on...
HPTX-ASPX-033115.jpg It was a "Merger Monday" for the biotech sector yesterday, with two blockbuster acquisitions being announced.
Pharma-033015.jpg It was a Merger Monday for the Biotech sector - with two deals being announced. Horizon Pharma plc (HZNP) is all set to acquire Hyperion Therapeutics Inc. (HPTX) for $46.00 per share or $1.1 billion in cash. Another deal of the day is the acquisition of Auspex Pharmaceuticals, Inc. (ASPX) by Teva Pharmaceutical Industries Ltd. (TEVA) for $101.00 per share in cash.
Pharma-032915.jpg Shares of Adamis Pharmaceuticals Corp. (ADMP) were down more than 34% in extended trading on Friday after the company's New Drug Application for Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe product for the emergency treatment of acute anaphylaxis was sent back to the drawing board by the FDA. Anaphylaxis is a potentially life-threatening allergic reaction.


Blue Bell Ice Cream of Brenham, Texas, is recalling three flavors of ice cream cups because they have the potential to be contaminated with the deadly bacterium Listeria monocytogenes.


Wegmans Food Markets Inc. is recalling about 12,540 packages of "Wegmans Organic Food You Feel Good About Just Picked Frozen Spinach" due to possible contamination with the deadly bacterium Listeria monocytogenes.


First Source LLC of Buffalo, New York is recalling 3,276 six-ounce plastic tubs of Wegmans Organic Walnut Halves & Pieces as they may have been contaminated with Salmonella, a bacterial organism that can lead to fever, diarrhea and vomiting.

Kraft Foods Group (KRFT) on Tuesday said it is recalling about 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner, as some boxes may contain small metal pieces. Kraft said the voluntary recall is limited to the 7.25-oz. size of the...

Date Company Name Ticker Drug Event Outcome Details
06/22/2015 Bristol-Myers Squibb Co. BMY Opdivo (BLA) FDA decision on Opdivo for the treatment of patients with advanced squamous non-small cell lung cancer after prior therapy
05/27/2015 Salix Pharmaceuticals Ltd SLXP XIFAXAN 550 mg tablets (sNDA) FDA decision on XIFAXAN for treatment of irritable bowel syndrome with diarrhea
05/27/2015 Salix Pharmaceuticals Ltd SLXP XIFAXAN (sNDA) FDA decision on XIFAXAN he treatment of irritable bowel syndrome with diarrhea or IBS-D
05/13/2015 KYTHERA BIOPHARMACEUTICALS INC KYTH ATX-101 (NDA) FDA decision on ATX-101 for improvement in the appearance of moderate to severe submental fullness
04/30/2015 Vernalis plc VNLPY.PK Tuzistra (NDA) FDA decision on Tuzistra for the treatment of cough and cold
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
ZS Pharma Inc. (ZSPH) has now offered to sell 4.02 million shares of common stock to the public at a price of $46.25 each.
Retrophin Inc. (RTRX) is offering to sell 6.84 million shares of its common stock to the public at a price of $19.00 each.
The overall fast food consumption of U.S. kids may be decreasing, according to a new study from researchers at Tufts University in Medford, Massachusetts. For the study the researchers compared data collected as part of the National Health and Nutrition Examination Surveys. They found that in the 2003 survey, roughly 39 percent of kids in the U.S. reported eating fast food at least once a day.
There may be a link between the family income of a household and the brain structure of its children, according to a new study from researchers at the Children's Hospital Los Angeles and the University of Southern California Keck School of Medicine. For the study the researchers used MRIs to examine the brain structure of 1,100 children and also reviewed financial records from each child's home.
Scientist have unearthed fossil remains of monster salamanders that is said to have roamed the earth about 230 million years ago. The salamander, known as metoposaurus algvarnesis, is an animal that has a head like a toilet seat with hundreds of sharp teeth and the size of a car. The fossils of the...