Policy
In the battle over drug prices, one sector of the healthcare industry has risen above all the players as the boogeyman: pharmacy benefit managers. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the lens now focused on PBMs’ business practices.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug.
Pharma CEOs claim lifesaving drugs wouldn’t be possible without high prices — an assertion that doesn’t stand up to scrutiny.
With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags.
The regulator on Wednesday gave its approval for a new oral antibiotic to treat uncomplicated urinary tract infections in women. UTILITY therapeutics expects to launch Pivya in the U.S. in 2025.
The FTC’s final rule banning most new noncompetes should go into effect later this year, although it faces opposition from the U.S. Chamber of Commerce.
A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity.
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.