Biotechnology News

Incyte Corp. (INCY) announced the U.S. FDA has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease. Ruxolitinib is a JAK1/JAK2 inhibitor approved by the U.S. FDA as Jakafi (ruxolitinib), for treatment of people with polycythemia...
OPKO Health Inc. (OPK) announced that the U.S. Food and Drug Administration has approved RAYALDEE (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism or SHPT in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less...
Hologic, Inc. (HOLX) and Grifols (GRFS) said that the U.S. Food and Drug Administration or FDA has approved use of the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) study protocol. Prominent U.S. blood centers will use the...
Pharma-061016.jpg Shares of Pluristem Therapeutics Inc. (PSTI) rose over 11% on Wednesday, following positive data from the company's preclinical studies of PLX-PAD cells in the treatment of Duchenne muscular dystrophy.
Pharma-062216.jpg Shares of Prima BioMed Ltd. (PBMD) were up over 10% in extended trading on Tuesday, following encouraging initial safety data from the first cohort of patients in its phase IIb clinical study of IMP321.
Pharma-062116.jpg Shares of ChromaDex Corp. (CDXC) plunged over 42% on Monday, following a report by short seller Bleecker Street Research, which details allegations of stock promotion and fraud.


Greenland Trading Corp. of Paterson, New Jersey is recalling AI Rasheed Sardine in seven states namely California, Florida, Massachusetts, New Jersey, New York, Pennsylvania and Tennessee, due to concerns over botulism.


Marin Foods Specialties Inc. is recalling packaged raw macadamia nuts sold at Whole Foods Market Stores in California, Nevada, Oregon and Washington due to possible contamination with the deadly Salmonella bacteria.


Let's Do Lunch Inc., dba Integrated Food Service, is voluntarily recalling certain ready-to-eat sandwiches due to contamination with the deadly bacterium Listeria monocytogenes.


Atkins Et Frères Inc. has recalled Smoked Maple Syrup Salmon from the marketplace due to possible contamination with the deadly bacteria Listeria monocytogenes. The recalled product was sold in retail store located in Mont-Louis, Quebec between June 6 and June 12, 2016.

Date Company Name Ticker Drug Event Outcome Details
12/15/2016 Dynavax Technologies Corp DVAX HEPLISAV-B (BLA) FDA decision on HEPLISAV-B for immunization of adults against hepatitis B infection
12/11/2016 Spectrum Pharmaceuticals Inc SPPI EOquin (NDA) FDA decision on EOquin for the treatment of non-invasive bladder cancer
11/30/2016 Lexicon Pharmaceuticals Inc. LXRX Telotristat Etiprate (NDA) FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
11/16/2016 Valeant Pharmaceuticals International VRX, VRX.TO Brodalumab (BLA) FDA decision on Brodalumab for treatment of patients with moderate-to-severe plaque psoriasis.
11/12/2016 Gilead Sciences Inc. GILD Tenofovir Alafenamide (TAF) (NDA) FDA decision on TAF for treatment of chronic hepatitis B
Results Date Company Name Ticker Event Indication Outcome
Late Sep 2016 GALECTIN THERAPEUTICS INC GALT Top-line data from Phase 2 trial with GR-MD-02 Non-alcoholic steatohepatitis (NASH) with advanced fibrosis
Late 2016 RedHill Biopharma Ltd. RDHL Top-line data Phase 3 study of Bekinda (GUARD study) Acute gastroenteritis and gastritis
Late 2016 ISIS Pharmaceuticals Inc ISIS Topline data from phase 3 study of ISIS-SMN Rx (ENDEAR) Spinal muscular atrophy in infants
Late 2016 ISIS Pharmaceuticals Inc ISIS Top line data from the second phase 3 study of ISIS-SMNRx (CHERISH) Spinal muscular atrophy in children
Late 2016 Biomarin Pharmaceutical Inc. BMRN Results from phase 2 study of Talazoparib (BMN 673) (ABRAZO study) Locally advanced and/or metastatic breast cancer with germline BRCA mutations
Spark Therapeutics Inc. (ONCE) is offering to sell 3.5 million shares of its common stock to the public at a price of $45.00 each. The net proceeds to the company from this offering will be approximately $105.8 million. As of March 31, 2016, Spark had cash and cash equivalents of $275.0 million.
Living near an airport could cause a spike in your blood pressure, according to a new study. The study, presented at the European Society of Cardiology meeting in Sophia Antipolis, France, included 201 people between the ages of 40 and 66. Approximately half lived in an area with high levels of aircraft noise for more than three years.
Damage caused by walking or running could promote melanoma on the soles of the feet, a new study shows. The study, published in the New England Journal of Medicine, reviewed the medical data between January 1990 and December 2014 revealed 123 patients at Shinshu University Hospital of people who had been diagnosed with melanoma on the soles of their feet.