Regulatory
Following Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals in July 2023, the drug on Monday was approved in the European Union for treating the rare genetic disorder that causes progressive damage to the nervous system.
Gilead Sciences announced Monday it will purchase CymaBay Therapeutics and its investigational treatment seladelpar for primary biliary cholangitis, a type of liver disease that causes bile-duct damage.
Gilead Sciences is ending the development of magrolimab for the treatment of blood cancer following the FDA’s placement of a clinical hold on all its programs related to the drug.
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.
With manufacturing issues persisting, last year’s shortages of medicines, including chemotherapies, weight-loss drugs and antibiotics, will continue into 2024.
Politics aside, both the government and the pharmaceutical industry want to bring affordable effective therapies to patients. Implementation is the obstacle. Working together is the only way to modify the IRA to do what it intends to do: benefit patients.
The French vaccine maker on Monday said it sold a priority review voucher, which was awarded by the FDA in November 2023 alongside an approval for its chikungunya vaccine, to an undisclosed buyer.
The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
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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