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Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs

 
• By Derrick Gingery

US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

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Janssen Pharmaceutical Cos.'s Elmiron (pentosan polysulfate) needs generic competition, FDA says.

The orphan drug indicated for relief of bladder pain or discomfort associated with interstitial cystitis was approved in 1996 and...

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Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
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Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.

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Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.

BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

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Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
• By Kevin Grogan

Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.

Executives On The Move: Five New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?