Merck Calls It Quits On Anacetrapib

Despite success in REVEAL outcomes trial, Merck will not submit the for the cholesteryl ester transfer protein (CETP) inhibitor for regulatory approval.

stopping the Dominio effect

Merck & Co. Inc. is making the prudent choice in opting not to pursue regulatory approval for the CETP inhibitor anacetrapib, avoiding what could have been a tricky review with only the possible reward being entry into the commercial quagmire of the cholesterol market that has hindered uptake of the PCSK9 inhibitor class.

"The decision follows a thorough review of the clinical profile of anacetrapib, including discussions with external experts," the firm said...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Product Reviews

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By 

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

More from Pink Sheet

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By 

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.