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How To Place Bets On Early Oncology Assets

 
• By Emily Hayes

With late-stage assets scarce, Campbell Alliance consultants offer tips for spotting early oncology opportunities, as part of Windhover’s Therapeutic Area Partnerships annual showcase of top unpartnered assets. MEI Pharma, Macrogenics and EnGeneIC are among the companies featured this year.

Drugs targeting cancer metabolism and unmet need in HER2-positive breast cancer, as well as cytotoxic agents wrapped into novel delivery technologies, are among the top 10 unpartnered oncology drugs to be showcased at Windhover’s Therapeutic Area Partnerships meeting in Boston from Nov. 28-30.

Each year at the TAP meeting, expert consultants present their take of the hottest unpartnered assets available for licensing in a range of therapeutic areas, including oncology, cardiovascular medicine, neuroscience...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.