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Health Reform in 2013: The Sprint to the Starting Line

 
• By Michael McCaughan

The Affordable Care Act has nearly died at least three times since the final bill took shape in 2010; with the re-election of Barack Obama, it is all systems go. But remember, the race to implement the program by 2014 is only the beginning, not the end, of health care reform.

Minutes after the major news networks called Ohio (and the Presidency) for Barack Obama on November 7, Rock Creek Policy’s Ian Spatz summed up the significance of the election for health care policy on Twitter: “ACA has now passed its 3rd test (passage, SCOTUS, re-election) and coverage expansion will be implemented in 2014.”

The impact of the Obama victory, of course, hasn’t been missed by anyone in the health care sector: the Affordable...

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

Leqembi Facing 15% Price Cut In Japan

 
• By Lisa Takagi

Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

 
• By Cathy Kelly

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 
• By Francesca Bruce

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.