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RSS FeedPosted by Michael Wonder on 19 Apr 2022
Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...
Posted by Michael Wonder on 18 Apr 2022
Switzerland approves its first protein-based Covid vaccine
15 April 2022 - Swissmedic announced its approval on Wednesday making Nuvaxovid the first protein-based vaccine to be licensed in Switzerland. ...
Posted by Michael Wonder on 18 Apr 2022
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...
Posted by Michael Wonder on 15 Apr 2022
Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals
14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...
Posted 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 ...