Biotechnology News

AstraZeneca (AZN.L) announced the US FDA has approved a blood-based companion diagnostic for TAGRISSO. The companion diagnostic, cobas EGFR Mutation Test v2, was developed by Roche Molecular Systems. The company said the approval provides a new, non-invasive option to identify patients with metastatic...
The U.S. Food and Drug Administration or FDA on Thursday announced that it approved Medical technology and services company Medtronic plc.'s (MDT) MiniMed 670G hybrid closed looped system. It is the first FDA-approved device that is intended to automatically monitor glucose and provide appropriate basal...
Vertex Pharmaceuticals Inc. (VRTX) announced that the U.S. Food and Drug Administration (FDA) approved ORKAMBI (lumacaftor/ivacaftor) for use in children with cystic fibrosis or CF ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest population...
Pharma-093016.jpg Shares of Threshold Pharmaceuticals Inc. (THLD) were down 64% in extended trading on Thursday as the overall results from two phase II proof-of-concept clinical trials of its drug candidate Tarloxotinib didn't warrant further development of the compound.
biotechstock-092916.jpg The biotech space is not for the faint hearted, given the ebbs and flows in terms of the returns from investing in it. However, for one who perseveres and astutely devises strategies with full cognizance of key regulatory events coming up, the probability of drug candidates getting FDA's blessings and sympathy plays in the space, it provides a sea of opportunity and huge upside prospects.
pharma-092916.jpg Alcobra Ltd.'s Investigational New Drug Applications for drug candidate MDX in Attention Deficit Hyperactivity Disorder and Fragile X Syndrome have been put on full clinical hold, following adverse neurological findings in a pre-clinical study.

Public health officials in Colorado are warning consumers not to consume raw milk and raw milk products from Larga Vista Ranch in Pueblo County as it may pose severe health risks like Campylobacter infections.


Kellogg Co. (K) is voluntarily recalling roughly 10,000 cases of Kellogg's Eggo Nutri-Grain Whole Wheat Waffles in 25 states due to potential contamination with the deadly Listeria monocytogenes bacteria.


SM Fish Corp. of Far Rockaway, New York, is voluntarily recalling select OSSIE'S brand ready-to-eat salads due to potential contamination with the deadly Listeria monocytogenes bacteria.


The Morrison Milling Co. is recalling Baker's Scoop HEB 100% Whole Wheat Flour due to possible soft nylon fragments of mesh resembling white hair, caused by a faulty screen at its production facility.

Date Company Name Ticker Drug Event Outcome Details
03/29/2017 Regeneron Pharmaceuticals REGN Dupilumab (BLA) FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
03/29/2017 Sanofi SNYNF, SNY Dupilumab (BLA) FDA decision on Dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis
02/28/2017 Lexicon Pharmaceuticals Inc. LXRX Telotristat Etiprate (NDA) FDA decision on Telotristat Etiprate for the treatment of carcinoid syndrome
02/23/2017 Clovis Oncology, Inc. CLVS Rucaparib (NDA) FDA decision on Rucaparib for the treatment of advanced mutant BRCA ovarian cancer.
01/29/2017 Synergy Pharmaceuticals, Inc. SGYP Plecanatide (NDA) FDA decision on Plecanatide for the treatment of chronic idiopathic constipation
Results Date Company Name Ticker Event Indication Outcome
Dec 2016 PROTEON THERAPEUTICS INC PRTO Topline data from phase 3 trial of Vonapanitase (PATENCY-1) To improve arteriovenous fistula patency for hemodialysis in patients with CKD
Dec 2016 INOTEK PHARMACEUTICALS CORP ITEK Topline data from 1st Phase 3 trial of Trabodenoson (MATrX-1) Primary open-angle glaucoma or ocular hypertension
01-Dec-2016 To 30-Mar-2017 Galmed Pharmaceuticals Ltd. GLMD Interim analysis of phase 2b trial of Aramchol(ARREST) Nonalcoholic steatohepatitis, or NASH
Dec 2016 ChromaDex Corp. CDXC Results from 2nd human clinical trial of NIAGEN Increase the mitochondrial co-enzyme NAD+ and NAD+ metabolite concentrations
Dec 2016 Cerecor Inc. CERC Topline data from phase 2 trial of CERC-501 smoking cessation
Capricor Therapeutics Inc. (CAPR) has offered to sell 3 million shares of its common stock at a price of $3.20 each. The proceeds to Capricor from the offerings are expected to be approximately $8.7 million. The company had cash of about $11.4 million at June 30, 2016.
Even a slight weight gain can hurt employment chances of a job seeker, especially women, according to a new study from the journal Plos One. In the study, it was found that people are less likely to select overweight women in a customer-facing job than an overweight man.
The FDA has issued up a warning that some forms of ovarian cancer tests may not be reliable. In a statement the agency has explained that several of the most reliable forms of screening are blood tests, but they may actually create spikes in the very biomarkers they are seeking. "Despite extensive research and published studies, there are currently no screening tests for ovarian cancer . . ."