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RSS FeedPosted by Michael Wonder on 14 Feb 2022
Bavarian Nordic announces breakthrough therapy designation for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
14 February 2022 - Bavarian Nordic announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's vaccine ...
Posted by Michael Wonder on 14 Feb 2022
Axcella Therapeutics announces FDA fast track designation for AXA1125 in NASH
14 February 2022 - EMMPACT Phase 2b clinical trial enrolling well, with interim data expected in mid 2022. ...
Posted by Michael Wonder on 14 Feb 2022
US FDA grants the coveted breakthrough designation for early stage prostate cancer detection blood test developed in India by Datar Cancer Genetics
14 February 2022 - It is the first blood test able to detect early stage prostate cancer with high accuracy ...
Posted by Michael Wonder on 14 Feb 2022
Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib
11 February 2022 - Spectrum Pharmaceuticals today announced that its new drug application for poziotinib has been accepted for review by ...
Posted by Michael Wonder on 13 Feb 2022
The FDA and its new commissioner must follow the science
13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...
Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of ...
Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...
Posted by Michael Wonder on 11 Feb 2022
Lilly's bebtelovimab receives emergency use authorisation for the treatment of mild to moderate COVID-19
11 February 2022 - Bebtelovimab neutralises Omicron as demonstrated by pseudovirus and authentic virus data ...
Posted by Michael Wonder on 11 Feb 2022
U.S. FDA advisers call for new trial of Lilly, Innovent lung cancer drug
10 February 2022 - Innovent Biologics and Eli Lilly should be required to conduct a trial of their lung cancer ...
Posted by Michael Wonder on 10 Feb 2022
Eli Lilly promises 40% discount for Innovent’s PD-1 in last-ditch bid to shift FDA review to drug pricing
10 February 2022 - Eli Lilly has been talking up a “disruptive” pricing strategy for its Innovent Biologics partnered PD-1 ...
Posted by Michael Wonder on 10 Feb 2022
Bayer receives U.S. FDA fast track designation for asundexian stroke program
10 February 2022 - Bayer today announced that the U.S. FDA has granted fast track designation for its investigational drug ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...
Posted by Michael Wonder on 10 Feb 2022
Gamida Cell initiates rolling submission of biologics license application for omidubicel
9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the ...
Posted by Michael Wonder on 10 Feb 2022
BioMarin sells priority review voucher for $110 million
9 February 2022 - BioMarin Pharmaceutical today announced that it has entered into a definitive agreement with an undisclosed purchaser to ...
Posted by Michael Wonder on 09 Feb 2022
FDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
9 February 2022 - Adds five years of market exclusivity on approval. ...