Regulatory
In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
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.
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