Policy
The European Medicines Agency is looking into how Novo Holdings’ recently announced $16.5 billion acquisition of contract manufacturer Catalent might affect the availability of drugs.
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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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The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.
With no well-controlled data to support its efficacy, the FDA rejected Aldeyra’s methotrexate injection for primary vitreoretinal lymphoma.
On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
Following an FDA warning in May, Novo Nordisk has filed several lawsuits against spas, clinics and pharmacies selling compounded version of semaglutide.
An International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.
Biopharma executives suggested that some companies might seek to bypass the U.S. government’s national health insurance program altogether, among other sweeping changes to drug development.
As geopolitical tensions rise in the region, AstraZeneca is looking at potentially spinning off its China unit into its own independent business.
While the German biotech that partnered with Pfizer on a COVID vaccine sees its first lawsuit, legal experts don’t expect similar cases in the U.S.
On the heels of a legal challenge to the Inflation Reduction Act by Merck, Bristol Myers Squibb on Friday filed its own lawsuit claiming that the law’s drug price negotiation provision is unconstitutional.