European Notebook: All Change In The C-Suites; EMA PRIME Starts; French Experts Recommend Phase I Changes

Once-in-a-decade leadership changes stack up in Europe’s big pharma companies as the region aims for quicker and more certain drug development, although following a recent fatality an expert committee is advising caution during dose-escalation in Phase I studies.

March has seen the latest CEO change announced at yet another of Europe's big pharma companies, with the announcement that GlaxoSmithKline PLC’s CEO Andrew Witty is to retire in Mar. 2017.

The move adds to the previously announced retirement of Bayer AG's chief executive Marijn Dekkers, the appointment of Stefan...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By 

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

More from Geography

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By 

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By 

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.