Biotechnology News

Pfizer Inc. (PFE) announced that the United States Food and Drug Administration has approved IXIFI or PF-06438179, infliximab-qbtx, a chimeric human-murine monoclonal antibody or mAb against tumor necrosis factor, as a biosimilar to Remicade or infliximab for all eligible indications of the reference...
GlaxoSmithKline plc (GSK, GSK.L) announced that the US Food and Drug Administration has approved Nucala or mepolizumab as the first targeted treatment for eosinophilic granulomatosis with polyangiitis or EGPA, previously known as Churg-Strauss syndrome. The approval for EGPA is based on results from...
Sanofi (SNYNF, SNY) reported that the U.S. FDA has approved Admelog, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. Admelog is a rapid-acting insulin similar to Humalog, another insulin lispro 100 Units/mL, currently approved in the U.S....
Pharma-121317.jpg Today's Daily Dose brings you news about Aduro's revised pipeline; FDA approval of a new indication for CoolSculpting; Blueprint's stock offering; encouraging preliminary results from Cellectis' CALM and PALL trials; expanded FDA approval for GlaxoSmithKline's Nucala and Omeros' OMIDRIA.
Pharma-120817.jpg Today's Daily Dose brings you news about AstraZeneca's phase I/II study evaluating Acalabrutinib alone and in combination in chronic lymphocytic leukemia; bluebird's update on LentiGlobin gene therapy product candidate in patients with severe sickle cell disease and Kura's phase II study results of Tipifarnib in patients with chronic myelomonocytic leukemia.
Repatha-Praluent-lawsuit-120817.jpg Rivalry is the life of trade, and it makes for some of the most compelling stories. The pharma industry, one of the fastest-growing economic sectors, too is dotted with many rivalry stories.


The Kroger Com. (KR) has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.

Rafedain Shish Kabob Restaurant, Inc. is recalling approximately 813 pounds of chicken patty shish kabob products due to presence of milk, wheat and soy, known allergens, which are not declared on the product label. There have been no confirmed reports of adverse reactions due to consumption of these products.

Caesar's Pasta, LLC, is recalling approximately 46,810 pounds of beef meatball products due to presence of egg, a known allergen, which is not declared on the product label. The problem was discovered when a customer noticed that the label did not include eggs in the ingredient statement. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.


Trafon Group, a Puerto Nuevo, P.R. establishment, is recalling approximately 297,828 pounds of chicken and pork products that were not presented at the U.S. point-of-entry for inspection. FSIS personnel discovered this problem on Nov. 10, 2017 while performing routine import verification activities. There have been no confirmed reports of adverse reactions due to consumption of these products.

Date Company Name Ticker Drug Event Outcome Details
05/21/2018 Dova Pharmaceuticals, Inc. DOVA Avatrombopag (NDA) FDA decision on Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease
05/17/2018 Amgen Inc. AMGN Aimovig (BLA) FDA decision on Aimovig for the prevention of migraine
03/02/2018 Otonomy Inc. OTIC OTIPRIO(sNDA) FDA decision on OTIPRIO for acute otitis externa
02/28/2018 Aerie Pharmaceuticals, Inc. AERI Rhopressa (NDA) FDA decision on Rhopressa for the treatment of patients with open-angle glaucoma or ocular hypertension
02/23/2018 Roche Holding AG RHHBY Emicizumab (BLA) FDA decision on Emicizumab for haemophilia A with inhibitors FDA approved Hemlibra, previously known as Emicizumab, on Nov.16, 2017
Results Date Company Name Ticker Event Indication Outcome
Q1 2018 Galmed Pharmaceuticals Ltd. GLMD Topline data from phase 2b study of Aramchol (ARREST) Nonalcoholic steatohepatitis or NASH
2018 MERRIMACK PHARMACEUTICALS, INC. MACK Results from phase 2 study of MM-121 Advanced or metastatic non-small cell lung cancer.
Early 2018 Prothena Corporation plc PRTA Topline results from phase 2b trial of NEOD001 (PRONTO) Previously-treated patients with AL amyloidosis and persistent cardiac dysfunction
2018 Xencor Inc XNCR Initial data from phase 2 study of XmAb5871 Systemic lupus erythematosus
Q1 2018 Galmed Pharmaceuticals Ltd. GLMD Interim data from phase IIa study of Aramchol (ARRIVE) HIV-associated lipodystrophy and nonalcoholic fatty liver disease