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340B Dispute Resolution Process On Ice As Feuds Between Pharma, Providers, HHS Heat Up

 
• By Cathy Kelly

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

HHS On The Hot Seat Over 340B Legal Questions

Former Health and Human Services Secretary Alex Azar’s last minute attempt to appoint a board to oversee a new 340B Administrative Dispute Resolution process at the department has been at least temporarily thwarted by the Biden Administration’s regulatory freeze. The Administration’s 21 January withdrawal of a rule to appoint the board will delay action on at least two ADR petitions that were recently filed against manufacturers.

Under a final rule establishing the ADR process, which was released in December, a six-member ADR board appointed by the...

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Brazil Could Look To Germany, UK & Australia For ATMP Drug Pricing Rules

 
• By Francesca Bruce

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

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National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.