Blog
RSS FeedPosted by Michael Wonder on 20 Jun 2022
FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
Posted by Michael Wonder on 19 Jun 2022
Drug pricing debate in Washington is a headache for pharma
17 June 2022 - Last-ditch effort by Democrats to pass slimmed-down version of Build Back Better could include measures on drug ...
Posted by Michael Wonder on 19 Jun 2022
Klobuchar, Porter call for FTC to investigate price hikes by Janssen, Bristol Myers Squibb
14 June 2022 - Two prominent Democratic lawmakers are requesting that the Federal Trade Commission investigate whether price hikes for ...
Posted by Michael Wonder on 19 Jun 2022
Canadian drug prices: new regulations could save billions of dollars
15 June 2022 - New drug price regulations set to come into effect next month could lower spending on patented ...
Posted by Michael Wonder on 16 Jun 2022
MHRA joins international partnerships to set global standards for medicines and medical devices regulation
16 June 2022 - These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for ...
Posted by Michael Wonder on 16 Jun 2022
Former FDA officials call for more transparency for drug approvals
15 June 2022 - The US FDA needs to take a more proactive approach in combatting misinformation and communicating decisions to ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 12 Jun 2022
Harvard professors continue to push misconceptions to justify drug price controls
10 June 2022 - The biopharmaceutical industry performed wonderfully during the COVID-19 pandemic. ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 09 Jun 2022
U.S. Senators ask regulators to clear drug patent 'thickets'
9 June 2022 - Letter asks U.S. Patent and Trademark Office to crack down on "highly similar" patents for single ...
Posted by Michael Wonder on 09 Jun 2022
Drug importation is dangerous and won’t lower prices
9 June 2022 - Federal and state governments continually insert themselves into the medical marketplace in an attempt to lower prescription ...
Posted by Michael Wonder on 09 Jun 2022
The days of the independent republic of PHARMAC are far from over
9 June 2022 - When he announced the government’s response to the recent independent review of PHARMAC Health Minister Andrew Little ...
Posted by Michael Wonder on 08 Jun 2022
MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran
8 June 2022 - The UK medicines regulator has awarded Alnylam’s RNAi based therapy zilebesiran for hypertension an ‘innovation passport‘, ...
Posted by Michael Wonder on 08 Jun 2022
Updated price disclosure guidelines, price disclosure webpages and price disclosure dispute resolution process
8 June 2022 - Amendments made to the National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 2017 by the ...
Posted by Michael Wonder on 08 Jun 2022
CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
6 June 2022 - Sugemalimab became the first anti-PD-1/PD-L1 monoclonal antibody approved for stage III NSCLC following concurrent or sequential chemoradiotherapy. ...