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December 15, 2023
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
December 14, 2023
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.
December 13, 2023
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
December 11, 2023
The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
Pharmaceutical Technology Europe® spoke with Fiona Bellot, sales director, Cellexus BioreactorSystems, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
December 08, 2023
AbbVie’s proposed acquisition of ImmunoGen is expected to accelerate AbbVie's entry into the commercial market for ovarian cancer and includes ImmunoGen’s flagship cancer therapy, ELAHERE (mirvetuximab soravtansine-gynx).
This collaboration will combine BigHat Biosciences’ AI/ML-guided Milliner platform with AbbVie's expertise in oncology and neuroscience to develop next-generation antibodies.