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Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process

 
• By Michael Cipriano

Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.

President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs.

Gottlieb, returning for what would be his third stint at the agency, has been a staunch proponent for flexible approval...

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Eli Lilly Thinks Twice About Lab Investment, Adding To UK Gloom

 
• By Andrew McConaghie

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Pharma CEOs Make Right Noises On MFN Pricing, But Wary Of Trump’s Lawmaking Commitment

 
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Leaders from Sanofi, AbbVie and Amgen aligned with Trump’s agenda at the Morgan Stanley healthcare conference, but also continued to push for ‘structural’ US market reforms.

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Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US and underlines that it isn’t a comprehensive healthcare fix. The feasibility of MFN pricing and why it may be “catastrophic” to the industry were some of the other topics discussed.

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EADV: UCB’s Bimzelx Primed To Maintain Pole Position in HS

 
• By Kevin Grogan

The Belgium-based group has collected heaps of long-term efficacy and safety data which will help stave off the competition.

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Pipeline Watch: Six Approvals And Twenty Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.