Biotechnology News

Gilead Sciences, Inc. (GILD) announced that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company's Type II variation application for once-daily Truvada (emtricitabine 200 mg/tenofovir...
Shares of Nicox S.A. (NICXF.PK) declined around 7 percent in the morning trading in Paris after the French ophthalmic company announced Friday that its partner Bausch + Lomb has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration, concerning latanoprostene bunod. Earlier...
Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) and Progenics Pharmaceuticals Inc. (PGNX) announced that the U.S. Food and Drug Administration has approved RELISTOR (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation or OIC. Valeant expects to commence sales of...
Pharma-072016.jpg Shares of Puma Biotechnology Inc. (PBYI) were up over 20% in extended trading on Thursday, following encouraging interim 5-year invasive disease free survival results from the company's phase III trial of PB272 (Neratinib) in extended adjuvant HER2-positive early stage breast cancer.
Pharma-072016.jpg Shares of AveXis Inc. (AVXS) jumped over 12% on Wednesday on news that the company's experimental drug AVXS-101 for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients has been granted Breakthrough Therapy Designation by the FDA.
Pharma-071916.jpg Shares of Zafgen Inc. (ZFGN) plunged over 40% in extended trading on Tuesday, after the company announced that it is suspending the development of its drug candidate Beloranib in Prader-Willi syndrome.


Agave Dream of Palos Verdes Peninsula, California is recalling 389 cases Cappuccino Ice Cream with Best By date 07/04/17 and UPC 899349002048 due to potential contamination with the deadly Listeria monocytogenes bacteria.


Monogram Appetizers of Plover, Wisconsin is recalling roughly 5,000 cases of Poppers Brand Mozzarella Cheese Sticks because it may contain egg, which is not declared on the label.


International Commissary Corp. is voluntarily recalling Marie Callender's 7oz & 14oz Cheese Biscuit Mix due to possible contamination with E. coli O121.


General Mills is expanding its previously announced flour recall to include two flavors of Betty Crocker cake mix sold in the U.S. and one flavor sold in Canada due to potential E. coli contamination.

Date Company Name Ticker Drug Event Outcome Details
01/07/2017 Anacor Pharmaceuticals, Inc. ANAC Crisaborole topical ointment, 2% (NDA) FDA decision on Crisaborole for treatment of mild-to-moderate atopic dermatitis in children and adults.
01/03/2017 Vericel Corporation VCEL MACI (BLA) FDA decision on MACI for the treatment of symptomatic cartilage defects of the knee in adult patients
12/28/2016 Roche Holding AG RHHBY OCREVUS (BLA) FDA decision on OCREVUS for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis
12/28/2016 Advanced Accelerator Applications S.A. AAAP Lutathera (NDA) FDA decision on Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors
12/28/2016 Cempra, Inc. CEMP Solithera oral (NDA) FDA decision on Solithera as a treatment for community-acquired bacterial pneumonia
Results Date Company Name Ticker Event Indication Outcome
Q4 2016 Corbus Pharmaceuticals Holdings, Inc. CRBP Topline data from phase 2 Study of Resunab Cystic Fibrosis
Q4 2016 MediciNova Inc MNOV, MNOV Interim efficacy analysis of Phase 2b Trial of MN-166 Progressive multiple sclerosis
Q4 2016 Heat Biologics Inc. HTBX Topline data from Phase 2 trial of HS-410 High-risk, non-muscle invasive bladder cancer
Q4 2016 Heat Biologics Inc. HTBX Topline data from Phase 1b trial of HS-110 plus a PD-1 checkpoint inhibitor Non-small cell lung cancer
Q4 2016 INOTEK PHARMACEUTICALS CORP ITEK Topline data from 1st Phase 3 trial of Trabodenoson (MATrX-1) Primary open-angle glaucoma or ocular hypertension
The number of drug resistant cases of gonorrhea have increased in the U.S. in recent years, according to a new study from researchers at the Centers for Disease Control and Prevention. The agency released an official statement earlier this week noting that "the future of current treatment options may be in jeopardy."
Use of the wildly popular new gaming app Pokemon Go may help people with mental illness feel better, according to a new study from researchers at Media Psychology Research Center in Newport Beach, California. According to the Center's report, users that are otherwise largely sedentary and bound to the indoors may be getting more exercise and social interaction than normal because of the game.