Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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.
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Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
The Federal Trade Commission is asking for more information regarding Pfizer’s planned $43 billion acquisition of Seagen, according to the latter’s Securities and Exchange Commission filing on Friday.
This week: Cancer license deals from J&J and BeiGene, a potential $7B acquisition by Roche and confirmed $1.9B Lilly buy, EU fine for Illumina, and more legal challenges to the Inflation Reduction Act
Bringing new drugs to the market costs billions of dollars. It could not be done without investments by both the NIH and biopharma companies.
A new report by the U.S. Government Accountability Office finds that despite the promise of regenerative medicine technologies they are held back by regulatory and manufacturing challenges.
After beginning July with a splash in the Alzheimer’s space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.
For over three years, no interest has accrued on federal student loans and no payments were required. Soon, mandatory payments will resume, leaving workers with less money in the bank.
Following its initial lawsuit last month, Merck has now requested that a federal judge rule on its Inflation Reduction Act case against the Biden administration without a trial.