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U.K. Early Access Scheme Now Open To All Comers, But Smaller Firms May Be Scared

 
• By Faraz Kermani

MHRA will not limit the number of drugs that could be awarded the designation, but the lengthy, expensive application process could effectively limit the number of small firms that can take advantage of it.

Interest amongst drug manufacturers in the U.K. government’s Early Access to Medicines Scheme could see the potential number of qualifying drugs rise from a meager two per annum to four or even eight, according to presentations at a joint BioIndustry Association and Association of the British Pharmaceutical Industry event April 28.

Daniel O’Connor, Expert Medical Assessor at the U.K.’s Medicines and Healthcare Products Regulatory Agency said in his presentation on the...

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More from Europe

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 
• By Eliza Slawther

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

More from Geography

Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.