Regulatory
Republican lawmakers have called on the Food and Drug Administration to explain its foreign inspection programs for drug manufacturers in China and India as shortages continue in the U.S.
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
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 closing its $8 billion acquisition of Grail without regulatory approval, the European Union has slapped Illumina with a record $476 million fine—the maximum sanction allowed under the EU’s rules.
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
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