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Ipsen’s $952 million acquisition of Albireo is designed to bolster the company's rare disease portfolio.

Ipsen to Bolster Liver Disease Portfolio with Albireo Acquisition

Sartorius and RoosterBio will work together to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies.

Sartorius and RoosterBio Strike Downstream Collaboration Deal

Getinge is launching Livit Flex, a bioprocess control system designed to help pharmaceutical and biotech products get to market faster.

Getinge Announces New BioProcess Control System

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

FDA Grants Accelerated Approval for Eisai Alzheimer’s Disease Treatment

Astrea Bioseparations has acquired Delta Precision, a manufacturer of chromatography columns for biomanufacturing.

Astrea Bioseparations Acquires Delta Precision

Avantor and Catalent have entered into a multi-year supply and services agreement. 

Avantor and Catalent Enter Multi-Year Agreement

 Washington Editor, jillwechsler7@gmail.com.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

FDA Policy Change Heightens Debate Over Medicated Abortion 

She also mentioned the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) launching at the same time to help energize the clinical research area of the EU.

EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

Highlights of December 2022 EMA Management Board Meeting

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

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