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FDA Approves Vivus’ Obesity Drug, Recommends Against Use In High-Risk Heart Patients

 
• By Cathy Dombrowski

A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies

FDA approved Vivus Inc.’s weight management drug Qsymia July 17 but is recommending the phentermine/topiramate combination not be used in patients with recent (within the last six months) or unstable heart disease or stroke.

Cardiovascular safety has been behind much of the delay on the trio of obesity drugs that have been attempting to...

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Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 
• By Francesca Bruce

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

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US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.