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Should Patents On REMS Distribution Restrictions Be Banned?

 
• By Sue Sutter

Citing the use of Risk Evaluation and Mitigation Strategies to delay generic entry, Boston researchers urge Congress to revisit an “unintended consequence” created by the 2007 FDA Amendments Act.

Congress should consider new legislation to either ban patents covering Risk Evaluation and Mitigation Strategies or bar brand name companies from invoking those patents against potential ANDA filers, drug safety researchers at Brigham and Women’s Hospital argue in the April 17 New England Journal of Medicine.

In their perspective piece, “Using A Drug Safety Tool To Prevent Competition,” researchers Ameet Sarpatwari, Jerry Avorn and Aaron Kesselheim...

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More from United States

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

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

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

More from North America

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 
• By Alaric DeArment and Cathy Kelly

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

 
• By Cathy Kelly

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

‘Missed Opportunity’: GSK Failed To Optimize Blenrep Dosage, US FDA Panel Says

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.