Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2021
J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...
Posted by Michael Wonder on 27 Jul 2021
Sol-Gel Technologies announces FDA approval of Twyneo
27 July 2021 - Twyneo utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038. ...
Posted by Michael Wonder on 27 Jul 2021
How Biogen found a believer: at the FDA, a hard nosed regulator was won over on controversial Alzheimer’s drug
27 July 2021 - When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts last ...
Posted by Michael Wonder on 27 Jul 2021
Day One receives FDA rare paediatric disease designation for DAY101 for the treatment of paediatric low grade glioma
27 July 2021 - Day One Biopharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 27 Jul 2021
FDA approves Keytruda (pembrolizumab) for treatment of patients with high-risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, then continued as single agent as adjuvant treatment after surgery
27 July 2021 - Keytruda is now approved in the US for 30 indications. ...
Posted by Michael Wonder on 26 Jul 2021
BeiGene announces approval in Canada of Brukinsa (zanubrutinib) for the treatment of patients with mantle cell lymphoma
26 July 2021 - Second approval for BTK inhibitor Brukinsa in Canada. ...
Posted by Michael Wonder on 26 Jul 2021
TGA international engagement strategy 2021-2025
26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...
Posted by Michael Wonder on 26 Jul 2021
NICE and partners announce this year’s theme for World Evidence Based Healthcare Day
26 July 2021 - NICE and six other global leaders in evidence based healthcare will this year shine a light ...
Posted by Michael Wonder on 26 Jul 2021
Drug pricing will make or break Democrats’ health care agenda
26 July 2021 - Committee leaders seek common ground on drug pricing. ...
Posted by Michael Wonder on 26 Jul 2021
Iterum Therapeutics receives complete response letter from U.S. FDA for oral sulopenem
26 July 2021 - Iterum Therapeutics today announced that it received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 26 Jul 2021
Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa
26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...
Posted by Michael Wonder on 26 Jul 2021
Rhythm Pharmaceuticals announces European Commission authorisation of Imcivree (setmelanotide) for the treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency
23 July 2021 - First ever authorised treatment option in the European Union for these rare genetic diseases of obesity. ...
Posted by Michael Wonder on 26 Jul 2021
Bristol Myers Squibb statement on Opdivo (nivolumab) monotherapy post sorafenib hepatocellular carcinoma U.S. indication
23 July 2021 - In consultation with the U.S. FDA, Bristol Myers Squibb has made the difficult decision to voluntarily withdraw ...
Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
Posted by Michael Wonder on 25 Jul 2021
COVID-19 demand leads to Australian shortages of rheumatoid arthritis drug
25 July 2021 - Australia is facing shortages of a rheumatoid arthritis drug that has been used to treat COVID-19 ...