When you think about the impact of the Food & Drug Administration’s focus on real-world drug safety, the disruptive implications of the Affordable Care Act, and the relentless pressure to find savings in health care, it is easy to see the dangers posed to biopharma companies. But those forces aren’t all negative. In fact, they are helping to mobilize government, consumer groups and payors to push hard on at least one decidedly pro-pharma agenda: improving adherence with prescription medicines.
Laura Helbling
When you think about the impact of the Food & Drug Administration's focus on real-world drug safety, the disruptive implications...
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Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.
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.
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
