Biotechnology News

Sales-Decline-042516.jpg Exclusivity vests the enviable privilege of having something for oneself, keeping others at bay. It is quite logical that you are hurt like hell when you are forced to share the fruits of years of investment in time, efforts and money with others who may have barely lifted a finger for it.
AstraZeneca (AZN.L, AZN) announced that the US Food and Drug Administration has approved Bevespi Aerosphere or glycopyrrolate and formoterol fumarate inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease or...
astrazeneca-042216.jpg Shares of Anglo-Swedish pharma giant AstraZeneca (AZN) are down over 11 percent year-to-date as the company gears up to face another patent cliff this year. This pales before the 4 percent gain by its predator Pfizer and Merck's 8 percent advance.
pharma-042816.jpg The New Drug Application for RAYALDEE, resubmitted by OPKO Health Inc. (OPK), has been accepted for review by the FDA, and a decision is scheduled for October 22, 2016.
pharma-040716.jpg BioTelemetry Inc. (BEAT) has reported revenue of $48.6 million for the first quarter ended March 31, 2016, which is the highest quarterly revenue in the company's history, and a 12% increase over prior year.
PharmaDaily-042616.jpg The FDA panel has voted down Sarepta Therapeutics Inc.'s (SRPT) Eteplirsen, proposed for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.


CVS Pharmacy has voluntarily recalled select cases of Gold Emblem Abound Organic Spiced Herbal Tea due to potential contamination with the deadly Salmonella bacteria.


Frozen fruit and vegetable producer CRF Frozen Foods is voluntarily recalling fifteen frozen vegetable items because of possible contamination with the deadly bacterium Listeria monocytogenes.

Nature's Touch Organic Berry Cherry Blend, a frozen fruit product, sold exclusively at Costco stores, has been blamed for the outbreak of Hepatitis A infections in three provinces in Canada.


Granna's LLC, which produces around fifty different frozen meals, is voluntarily recalling packages of '#808 French Toast with diced potatoes and mandarin oranges' as it contains milk not declared on the label.

Date Company Name Ticker Drug Event Outcome Details
10/22/2016 Medivation Inc. MDVN XTANDI (sNDA) FDA decision on XTANDI in metastatic castration-resistant prostate cancer with data from head-to-head studies of Enzalutamide Vs Bicalutamide
10/22/2016 OPKO Health Inc. OPK RAYALDEE (NDA Resubmission) FDA decision on RAYALDEE for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 CKD and vitamin D insufficiency.
10/19/2016 Roche Holding AG RHHBY Atezolizumab (BLA) FDA decision on Atezolizumab for the treatment of specific type of lung cancer
10/14/2016 Egalet Corp. EGLT ARYMO ER (NDA) FDA decision on ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
09/25/2016 Amgen Inc. AMGN ABP 501 (BLA) FDA decision on ABP 501 as a biosimilar to AbbVie’s immunosuppressant Humira
Results Date Company Name Ticker Event Indication Outcome
Q3 2016 GALECTIN THERAPEUTICS INC GALT Top-line data from Phase 2 trial with GR-MD-02 Non-alcoholic steatohepatitis (NASH) with advanced fibrosis
2H 2016 GW Pharmaceuticals PLC GWPH, GWP.L Top-line data from 2nd phase 3 trial of Epidiolex Dravet syndrome
2H 2016 CytRx Corp. CYTR Report PFS data from Phase 2b trial of Aldoxorubicin Relapsed/refractory small cell lung cancer
2H 2016 OncoGenex Pharma OGXI Survival results from phase III trial of Custirsen (ENSPIRIT trial) Advanced or metastatic non-small cell lung cancer (NSCLC)
Q3 2016 Anthera Pharmaceuticals, Inc. ANTH Topline efficacy and safety data from phase 3 study of Blisibimod (CHABLIS-SC1) Systemic Lupus Erythematosus
DURECT Corp. (DRRX) has offered to sell 12 million shares of its common stock to the public at a price of $1.25 each. The offering, which is slated to close on or about April 29, 2016, is expected to bring in gross proceeds of about $15 million. At year-end 2015, the company had cash of $29.3 million.
Cellectar Biosciences Inc. (CLRB) has offered to sell shares, or pre-funded warrants in lieu thereof, at a price of $2.13 per share and associated traditional warrants.
Children from lower income families suffering from allergies may suffer worse from their symptoms than those from higher income families, according to a new study from researchers at the Program for Maternal and Child Health at Northwestern Feinberg School of Medicine in Chicago. For the study the researchers reviewed data collected from 1,200 parents of food allergies.
The FDA has issued a warning that a common yeast infection drug may lead to miscarriages for some women. The FDA's warning follows a recent study from Danish researchers claiming that the drug oral fluconazole could pose some birth risks. The drug, which is marketed in the U.S. under the brand name Diflucan, currently has no warning on its label about possible birth defects.