Biotechnology News

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Thursday that the European Medicines Agency or EMA has accepted for review the Marketing Authorization Application for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis or AD who are candidates for...
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co. (LLY) said that the U.S. Food and Drug Administration has approved a new indication for Jardiance or empagliflozin tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease....
EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (PFE) announced that the US Food and Drug Administration has accepted for Priority Review EMD Serono's Biologics License Application or BLA for avelumab. The review relates to avelumab's...
Pharma-120716.jpg Shares of Voyager Therapeutics Inc. (VYGR) surged over 35% in after-hours on Wednesday, following positive interim results from phase Ib trial of VY-AADC01 for advanced Parkinson's disease.
Pharma-120616.jpg Shares of Cerecor Inc. (CERC) plunged over 13% on Monday on disappointing top-line clinical results from its phase II clinical trial of CERC-501 for smoking cessation.
Pharma-120516.jpg Alnylam Pharmaceuticals Inc. (ALNY), on Sunday, reported positive interim clinical results of its investigational RNAi therapeutic Fitusiran from an ongoing phase II open label extension study in patients with Hemophilia A or B without inhibitors.


Ultimate Body-Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules, marketed as dietary supplement for weight loss, as they contain undeclared Sibutramine.


Hale and Hearty Soups LLC is recalling roughly 455 pounds of ready-to-eat chicken chili soup product due to possible contamination with the deadly Listeria monocytogenes bacteria, the U.S. Department of Agriculture's Food Safety and Inspection Service said.


ISB Food Group LLC is recalling its L.A. Creamery brand ice cream of Salted Caramel flavor and Honeycomb flavor as well as Nancy's Fancy brand ice cream of Butterscotch Budino flavor and Peanut Butter with Crunchy Peanuts flavor due to possible health risk.


AC Creamery Inc. of Anaheim, California, is recalling its "Manila Sky Purple Yumm Ice Cream" due to potential contamination with the deadly Listeria monocytogenes bacteria.

Date Company Name Ticker Drug Event Outcome Details
05/07/2017 TherapeuticsMD TXMD Yuvvexy (NDA) FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
05/01/2017 Novartis AG NVS LEE011 (NDA) FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
04/29/2017 Ariad Pharmaceuticals Inc ARIA Brigatinib (NDA) FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
04/27/2017 Biomarin Pharmaceutical Inc. BMRN Brineura (BLA) FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
04/18/2017 AstraZeneca PLC AZN.L, AZN ZS-9 (NDA resubmission) FDA decision on ZS-9 for the treatment of hyperkalaemia
Results Date Company Name Ticker Event Indication Outcome
Mar 2017 22nd Century Group Inc. XXII Completion of phase 3 study of SPECTRUM tobacco harm caused by smoking
Mid Feb 2017 Biota Pharmaceuticals Inc. AVIR Topline data from phase 2b trial of Vapendavir (SPIRITUS) Adult asthmatics with symptomatic human rhinovirus
Q1 2017 Ardelyx, Inc ARDX Results from 1st phase 3 trial of Tenapanor Hyperphosphatemia in ESRD patients
Q1 2017 Alcobra Ltd. ADHD Data from 2nd phase 3 study of Metadoxine Extended Release (MEASURE) Adults with ADHD
Early 2017 Karyopharm Therapeutics Inc. KPTI Top-line data from Phase 2b study of Selinexor (SADAL study) Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Older adults who suffer from dementia, or mild cognitive impairment, may benefit from aerobic exercise, according to a new study. The study, to be presented Wednesday at the Radiological Society of North America, included 16 people with an average age of 63, who did aerobic workouts on a treadmill, stationary bike or elliptical training. They worked out four times a week for six months.
The Food and Drug Administration has given permission for large-scale, Phase 3 clinical trials of MDMA— a final step before the possible approval of ecstasy as a prescription drug to treat posttraumatic stress disorder. The New York Times uses the example of an American soldier, C.J. Hardin who served in both Iraq and Afghanistan. Hardin tried all available methods of treating PTSD.