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RSS FeedPosted by Michael Wonder on 07 Jun 2021
SMC - June 2021 decisions
7 June 2021 - Advice on five new medicines for use in conditions including advanced gastric cancer and chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 07 Jun 2021
ICER issues statement on the FDA’s approval of aducanumab for Alzheimer’s disease
7 June 2021 - The ICER believes that the FDA, in approving aducanumab (Aduhelm, Biogen) for the treatment of Alzheimer’s ...
Posted by Michael Wonder on 07 Jun 2021
FDA grants accelerated approval for Alzheimer’s drug
7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...
Posted by Michael Wonder on 07 Jun 2021
GSK’s PD-1 inhibitor Jemperli approved in the UK
7 June 2021 - GSK's PD-1 inhibitor Jemperli has been authorised by the UK MHRA for the treatment of recurrent ...
Posted by Michael Wonder on 07 Jun 2021
After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug
3 June 2021 - In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after ...
Posted by Michael Wonder on 07 Jun 2021
Post-market review of medicines for smoking cessation – public consultation on the draft report
7 June 2021 - The draft report for the post-market review of medicines for smoking cessation is available for public comment ...
Posted by Michael Wonder on 06 Jun 2021
The parents hoped an existing drug might keep their kids from having seizures. Then they saw the price.
3 June 2021 - When Amber Freed heard in 2020 that a drug might help save her young child from ...
Posted by Michael Wonder on 06 Jun 2021
NICE publishes appraisal consultation document for medicine for excessive daytime sleepiness
3 June 2021 - The Department of Health and Social Care has asked the NICE to produce guidance on using pitolisant ...
Posted by Michael Wonder on 06 Jun 2021
FDA’s decision on Biogen Alzheimer’s drug will be a watershed moment for the agency — and the biotech industry
4 June 2021 - In the coming days the FDA will make one of its most important — and controversial — ...
Posted by Michael Wonder on 05 Jun 2021
Alzheimer’s drug poses a dilemma for the FDA
5 June 2021 - If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. ...
Posted by Michael Wonder on 05 Jun 2021
Newly approved obesity drug Wegovy holds promise, but faces reimbursement challenges
5 June 2021 - On 4 June, the FDA approved Novo Nordisk’s obesity drug Wegovy (semaglutide), a glucagon-like peptide 1 receptor ...
Posted by Michael Wonder on 05 Jun 2021
Put Canadians first by suspending the implementation of harmful drug pricing regulations
4 June 2021 - Innovative Medicines Canada calls on the federal government to suspend the implementation of the Patented Medicines ...
Posted by Michael Wonder on 05 Jun 2021
Could big pharma actually lose this fight over drug prices? It's Biden's call.
3 June 2021 - More than 20 years ago, when I was the press secretary for then-Congressman Bernie Sanders, I rode ...
Posted by Michael Wonder on 05 Jun 2021
Chimerix receives U.S. FDA approval for Tembexa (brincidofovir) for the treatment of smallpox
4 June 2021 - First smallpox anti-viral approved for all age groups, including infants, and patients who have difficulty swallowing. ...
Posted by Michael Wonder on 05 Jun 2021
FDA approves new drug treatment for chronic weight management, first since 2014
4 June 2021 - Today, the U.S. FDA approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in ...