Biotechnology News

Sandoz, a Novartis company (NVS), announced the US approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. Glatopa, developed in collaboration with Momenta and produced entirely in the US, is indicated for...
Alcon, the global leader in eye care and a division of Novartis (NVS), said that it has received approval from the US Food and Drug Administration or FDA for its AcrySof IQ ReSTOR +2.5 Diopter or D Intraocular Lens or IOL for patients undergoing cataract eye surgery who choose to address their near,...
AbbVie (ABBV) said Wednesday that the Japanese Ministry of Health, Labour and Welfare or MHLW has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. This all-oral treatment is interferon or IFN and ribavirin or (RBV-free and...
Pharma-041615.jpg Shares of MediciNova Inc. (MNOV) surged more than 41% on Thursday, following receipt of FDA's Fast Track designation for the company's phase II-ready compound - MN-001 - for the treatment of patients with nonalcoholic steatohepatitis with fibrosis.
Pharma-041515.jpg Shares of Celsion Corp. (CLSN) rose more than 18% on Wednesday following positive interim data from the company's ongoing open-label phase 2 trial of ThermoDox in recurrent chest wall breast cancer.
Pharma-041315.jpg Galena Biopharma Inc. (GALE) has completed enrollment in its phase III trial of NeuVax, a first-in-class, HER2-directed cancer immunotherapy, under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.


Henry's Farm Inc. of Woodford is recalling all packages of soybean sprouts because they may be contaminated with the deadly bacterium Listeria monocytogenes. This is the second recall in less than 5 months by Henry's Farm as the company had issued a similar recall of soybean sprouts citing the same reason last November.


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.

Date Company Name Ticker Drug Event Outcome Details
07/05/2015 Vertex Pharmaceuticals Inc. VRTX Lumacaftor / Ivacaftor combo FDA decision on Lumacaftor / Ivacaftor combo in people with CF ages 12 and older who have two copies of the F508del mutation
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 FDA approved Opdivo on Mar.4, 2015
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 Amgen Inc. AMGN Corlanor (NDA) FDA decision on Corlanor to treat heart failure FDA approved Corlanor on April 15, 2015
05/27/2015 Salix Pharmaceuticals Ltd SLXP XIFAXAN (sNDA) FDA decision on XIFAXAN he treatment of irritable bowel syndrome with diarrhea or IBS-D
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
SAGE Therapeutics Inc. (SAGE) has offered to sell 2.28 million shares of its common stock to the public at a price of $52.50 each. The underwriters have a 30-day option to purchase up to an additional 342,857 shares of common stock on the same terms and conditions.
uniQure N.V. (QURE) has priced its follow-on public offering of 3 million ordinary shares at $29.50 each. The net proceeds of the follow-on public offering, which is scheduled to close on or about April 15, 2015, are expected to be approximately $82.4 million (EURO76.5 million).
A new study ties antidepressants to a higher risk for first-time seizures in people being treated for depression. The study, presented at the European Psychiatric Association (EPA) 23rd Congress, says that the kinds connected to the worse odds of having a first seizure were SSRIs, or selective serotonin reuptake inhibitors, SNRIs, or serotonin-norepinephrine reuptake inhibitors and others.
A marijuana extract may help reduce the frequency and strength of seizures in people with severe epilepsy, a new study has found. The study, which took place over twelve weeks at New York University's Langone Comprehensive Epilepsy Center, examined 137 people (aged toddler to adult) who had severe epilepsy.
It is a universally accepted fact that no tobacco product is safe, and this warning message is made mandatory on all tobacco products. But Swedish Match AB, the largest manufacturer of chewing tobacco, which claims that its "Snus" presents substantially lower risks to health than cigarettes, has been seeking to revise the warning label on the product.