Biotechnology News

Drug maker AstraZeneca (AZN, AZN.L), along with its biologics research and development arm MedImmune, Tuesday announced that the US Food and Drug Administration has accepted a supplemental Biologics License Application or sBLA for Imfinzi (durvalumab). It is for the treatment of patients with locally...
Exelixis, Inc. (EXEL) announced Monday that its global phase 3 CELESTIAL trial of Cabometyx (Cabozantinib) met its primary endpoint of overall survival in patients with advanced hepatocellular carcinoma or HCC. Separately, Exelixis announced that the FDA granted priority review for Cabozantinib as a...
Royal Philips (PHG) said that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the new eL18-4 transducer with full solution for 'small parts' assessment, which is an ultrasound exam to detect abnormalities in the small organs that are close to the skin. The Philips...
pharma-101717.jpg Today's Daily Dose brings you news about Restoration Robotics' closing of IPO; Immune Design's plans to initiate a pivotal phase 3 trial of CMB305 in patients with synovial sarcoma; Bristol-Myers' exploration of new indication for its blockbuster immunotherapy drug Opdivo and Fennec's SIOPEL 6 study results.
Agilent-101617.jpg Shares of Agilent Technologies Inc. (A) are up 47% year-to-date while the iShares U.S. Medical Devices ETF has gained only 15% during the same period.
Pharma-101317.jpg Today's Daily Dose brings you news about what's in store for Antares' XYOSTED; BioDelivery Sciences' Settlement Agreement with Teva; reverse stock split of CHF Solutions; FDA approval of Pfizer's LYRICA CR; and FDA panel recommendation for approval of Spark's gene therapy for blindness.


The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Battistoni Italian Specialty Meats, LLC, a Buffalo, N.Y. establishment, is recalling approximately 22,630 pounds of ready-to-eat (RTE) Genoa Salami and Capocollo products that may have been contaminated with foreign matter.


The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that Vermont Livestock Slaughter and Processing, LLC, a Ferrisburg, Vt., establishment, is recalling approximately 133 pounds of ground beef products due to potential E. coli O157:H7 contamination.


The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that H-E-B Meat Plant, a San Antonio, Tex. establishment, is recalling approximately 1,150 pounds of diced chicken thighs due to misbranding and undeclared allergens. There have been no confirmed reports of adverse reactions due to consumption of these products.


Sid Wainer & Son of New Bedford, MA announced the recall of Jansal Valley brand Dried Chili De Arbol Peppers due to presence of allergen, peanuts. No illnesses have been reported to date in connection with this problem. During repacking, the peanut contamination was discovered in the sealed bulk containers of the product.

Date Company Name Ticker Drug Event Outcome Details
03/02/2018 Otonomy Inc. OTIC OTIPRIO(sNDA) FDA decision on OTIPRIO for acute otitis externa
02/14/2018 AMAG Pharmaceuticals Inc. AMAG, AMAG Makena subcutaneous auto-injector (sNDA) FDA decision on subcutaneous version of Makena to reduce the risk of preterm birth
01/24/2018 Synergy Pharmaceuticals, Inc. SGYP TRULANCE (sNDA) FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
01/12/2018 Ligand Pharmaceuticals Inc LGND LUXTURNA (BLA) FDA decision on LUXTURNA for inherited retinal disease
01/12/2018 Spark Therapeutics ONCE LUXTURNA (BLA) FDA decision on LUXTURNA for treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
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