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In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Career FDA Leaders Say Science Is Agency’s Guide

Tjoapack is investing in fully automated lines, including a PFS line with an initial capacity of 7 million syringes per year and a vial line with an eventual capacity of more than 12 million vials per year.

Tjoapack to Invest in Automated Injectables Packaging Capabilities

Takeda is divesting its portfolio of select, non-core prescription pharmaceutical products sold in Europe and Canada to Cheplapharm, a German pharmaceutical company.

Takeda to Divest Non-Core Assets for $562 million

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy. 

Cobra and CombiGene Sign Agreement for Plasmid Production for Gene Therapy

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.



PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked

ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members. 

ECCRT and IDDI Partner for Continuous Development

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC

CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.

CPhI Releases Virtual Event Agenda

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

MilliporeSigma Invests $65 Million to Expand Antibody-Drug Conjugate Manufacturing

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

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