Policy
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
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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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In its latest legal challenge to the Inflation Reduction Act, the U.S. Chamber of Commerce has appealed to a federal court to stop drug price negotiations until ongoing litigation plays out.
More than 3,000 state and local governments will receive nearly $19 billion in payments from drugmakers and pharmacy chains in the most recent round of opioid settlements.
Francis deSouza resigned from Illumina’s helm after strong campaigning from activist investor Carl Icahn and the ongoing regulatory roadblocks facing the company’s acquisition of GRAIL.
The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.
Promosome filed lawsuits Tuesday against Moderna and Pfizer/BioNTech, alleging that the vaccine developers used patent-protected mRNA technology without a license.
The Federal Trade Commission’s lawsuit takes an unusual strategy, according to legal experts, raising concerns and uncertainties in the biopharma industry.
In a lawsuit filed Tuesday in federal district court, Merck claimed that the price negotiation program laid out in the Inflation Reduction Act violates the U.S. Constitution.