logo

Biotechnology News

Share
Amgen (AMGN) and Allergan plc. (AGN) announced Thursday that the European Commission has granted marketing authorization for MVASI (biosimilar bevacizumab). MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers. This includes in...
Novartis (NVS) announced its supplemental Biologics License Application for Kymriah (tisagenlecleucel) suspension for intravenous infusion, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant...
Teva Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has approved the use of TRISENOX or arsenic trioxide injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized...
Read More
Epilepsy-011918.jpg Rare commodities are worth more than good is a Chinese adage. And more so when it is in the field of medicine.
Pharma-011818.jpg Today's Daily Dose brings you news about Aeterna's alliance with Strongbridge; a new study about CellMax-CRC Colorectal Cancer Screening test and Novartis' Kymriah getting priority review from the FDA for a second indication.
Pharma-011718.jpg Today's Daily Dose brings you news about Juno's suitor; Eiger's failed LIBERTY trial; encouraging hepatocellular carcinoma trial data of Ipsen and Exelixis; MiMedx's progress in recalcitrant plantar fasciitis pain trial; positive FDA feedback related to the design of Athenex's breast cancer trial and MabVax's clinical trial catalysts to watch out for this quarter.
Read More

Hemplers-Recall-010518.jpg

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that Ferndale, Wash. establishment Hempler Foods Group, LLC, is recalling approximately 4,068 pounds of pepperoni sticks products due to contamination of extraneous material, specifically metal.

Recall-CaliforniaPopsicle-010418.jpg

California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA, is recalling ice bars because it may contain undeclared milk. The recall was initiated after notification by FDA of a consumer complaint in Canada regarding an allergic reaction.

Pillers-Foods-Recalls-121817.jpg

Piller's Fine Foods is recalling approximately 1,076 pounds of ready-to-eat salami and speck products due to possible salmonella adulteration. However, there have been no confirmed reports of adverse reactions due to consumption of these products. The problem was discovered when an FSIS sample of the product tested positive for Salmonella.

Kroger-Recalls-ComfortsForBaby-121517.jpg

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.

Read More
Date Company Name Ticker Drug Event Outcome Details
06/27/2018 GW Pharmaceuticals PLC GWPH, GWP.L Epidiolex (NDA) FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
06/25/2018 Achaogen Inc. AKAO Plazomicin (NDA) FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
06/23/2018 scPharmaceuticals Inc. SCPH Furoscix (505(b)(2) NDA) FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
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
Read More
Results Date Company Name Ticker Event Indication Outcome
Q2 2018 Galmed Pharmaceuticals Ltd. GLMD Topline data from phase 2b study of Aramchol (ARREST) Nonalcoholic steatohepatitis or NASH
Q2 2018 Rexahn Pharmaceuticals inc. RNN Phase IIa data read-out of RX-3117 Metastatic Pancreatic Cancer (1st line treatment in combination with Abraxane)
Q2 2018 Axovant Sciences Ltd. AXON Top-line data from phase II study of Nelotanserin REM Behavior Disorder in subjects with Lewy Body Dementia
Q2 2018 Audentes Therapeutics, Inc. BOLD Preliminary data Phase 1 / 2 clinical study of AT342 (VALENS) Crigler-Najjar
Mar 2018 ARCA biopharma, Inc. ABIO Topline data from phase 2B trial of Gencaro (GENETIC-AF) Treatment and prevention of recurrent atrial fibrillation o
Read More
The American Depositary Shares of Immuron Limited (IMRN) have gained nearly 33% in the last 5 trading days.
Read More