Regulatory
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
The Federal Trade Commission and the company had been in settlement discussions, but those talks have ended as the agency’s antitrust lawsuit seeks to block the Horizon Therapeutics sale.
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.
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