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RSS FeedPosted by Michael Wonder on 14 Apr 2022
Merck announces US FDA has granted breakthrough therapy designation for V116, the Company’s investigational 21 valent Pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
14 April 2022 - V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 14 Apr 2022
COVID-19 vaccine weekly safety report (14 April 2022)
14 April 2022 - To 10 April 2022, the TGA has received 528 reports which have been assessed as likely to ...
Posted by Michael Wonder on 13 Apr 2022
Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)
13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...
Posted by Michael Wonder on 13 Apr 2022
Committee releases report uncovering significant conflicts of interest at McKinsey related to work for FDA and opioid manufacturers
13 April 2022 - Chairwoman Maloney calls on McKinsey’s global managing partner to testify at public hearing. ...
Posted by Michael Wonder on 13 Apr 2022
FDA takes important steps to increase racial and ethnic diversity in clinical trials
13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...
Posted by Michael Wonder on 13 Apr 2022
Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain
13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...
Posted by Michael Wonder on 13 Apr 2022
European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer
13 April 2022 - Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior ...
Posted by Michael Wonder on 13 Apr 2022
BriaCell receives FDA fast track approval for targeted breast cancer immunotherapy
13 April 2022 BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with ...
Posted by Michael Wonder on 13 Apr 2022
TGA approves Lumakras
13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...
Posted by Michael Wonder on 12 Apr 2022
US FDA grants fast track designation for Paradigm’s Phase 3 osteoarthritis program
12 April 2022 - Paradigm Biopharmaceuticals is pleased to announce that the U.S. FDA has granted fast track designation for ...
Posted by Michael Wonder on 12 Apr 2022
Health Canada has approved Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis
12 April 2022 - Zeposia is the first and only S1P receptor modulating agent approved for the treatment of ulcerative ...
Posted by Michael Wonder on 12 Apr 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction
12 April 2022 - Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in ...
Posted by Michael Wonder on 12 Apr 2022
EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
Posted by Michael Wonder on 12 Apr 2022
Myovant Sciences and Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
12 April 2022 - Myovant Sciences and Pfizer announced today an update on the Supplemental new drug application for Myfembree ...