Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
Anxiety is high as pharmaceutical manufacturers wait to hear from President Trump about whether or not drugs will be included in the next round of tariffs to be announced on 2 April.
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The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
