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US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

 
• By Sue Sutter

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

avastin look back
EVEN THOUGH IT WAS A DECADE AGO, AVASTIN’S HEARING IS STILL A GUIDEPOST FOR REGULATORS. • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

The public hearing on the US Center for Drug Evaluation and Research’s proposal to withdraw accelerated approval of Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) appears on track for 2022.

Although a hearing date is not yet announced, presiding officer Celia Witten is asking CDER and Covis to provide specific language by 14 February for voting questions related to three...

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Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 
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Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.

Novel Agents Up For US FDA Approval In 2025

 
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CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.

Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma

 
• By Francesca Bruce

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 
• By Bridget Silverman

Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.

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UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.