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Stock Watch: The Two Sides Of A Complete Response Letter

Acadia Comes Out Guns Blazing While The FDA’s Hands Are Tied

 
• By Andy Smith

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

A complete response letter (CRL) from the FDA instead of an approval will always be a disappointment to a drug sponsor. But while companies can issue robust responses by press release, the FDA treats all interactions with the drug sponsor as confidential.

The 2021 Easter weekend was probably curtailed for ACADIA Pharmaceuticals Inc.’s senior management team. First thing on Monday, Acadia...

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Wegovy’s Win In MASH Gives Novo A Much-Needed Edge Over Lilly

 
• By Manas Mishra

Just days after discontinuing a Phase III trial for a separate MASH compound, Novo Nordisk has secured the US FDA’s accelerated approval for Wegovy to treat the fatty liver disease.

Pipeline Watch: Seven Approvals And Five 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.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

Insmed Targets $5bn-Plus Market With Brinsupri For Bronchiectasis

 
• By Mandy Jackson

The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.

More from Scrip

Pipeline Watch: Seven Approvals And Five 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.

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.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion.