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Latest News & Analysis

Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees

'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.

Cancer Advisory Committees

Cadila Retreats From US Injectables Market After Tough FDA Inspection

Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.

Enforcement Manufacturing

Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short

Giroir's memo to FDA staff also says intends to coordinate with prior acting commissioner Norman Sharpless to ensure current activities continue.

FDA Leadership

GSK Seeks To Halt Boehringer Promos That 'Denigrate' Effectiveness Of Ellipta, Diskus Inhalers

US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.

Advertising, Marketing & Sales Legal Issues

Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod

Despite FDA's concerns, advisory committee unanimously endorses Vascepa's labeling expansion, with 10 of 16 members also favoring approval for secondary as well as primary prevention even as several voiced misgivings about efficacy in the REDUCE-IT trial's lower risk cohort.


Advisory Committees Drug Review

How To Make Cross-Country Collaborations On Pricing Work

Francis Arickx from the cross-country coalition BeNeLuxA spoke this month about how the initiative had delivered proof of concept and discussed why uniting across borders is important for delivering access to transformative but expensive medicines.  

Europe Health Technology Assessment

NGOs Urge Italian Govt Not To Replace Head Of Drugs Agency

The Italian health ministry is looking for someone to take over as director general of the medicines agency AIFA. The move has shocked health activists who see Luca Di Bassi as a champion of drug price transparency.

Italy Regulation

ViiV Seeks Speedy EMA Review For Last-Resort HIV Drug

ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.

Europe Drug Review

EU: Rigel And Jazz Among Hopefuls At CHMP

Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.

Europe BioPharmaceutical

Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel

Expanded indication for type 1 diabetes seems out of reach for the moment, but if Boehringer conducts a larger and lengthier trial, it could eventually persuade members of the Endocrinologic and Metabolic Drugs Advisory Committee who voted 14-2 against supplemental approval of empagliflozin for the proposed 2.5mg dose.

Advisory Committees Metabolic Disorders

ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities'

FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.

Manufacturing Quality

US FDA Oncology Leadership Shuffle Moves Patricia Keegan To OCE; Gootenberg Takes On Recruitment

US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.

Cancer Drug Review
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