Articles

The deal is expected to close during the second half of 2020.

J&J to Acquire Momenta Pharmaceuticals for $6.5 billion

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely. 

FDA May Delay Approval of Drugs Where Necessary Inspection Is Not Feasible

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

Compounded Heparin Sodium Recalled

The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study.

FDA Publishes Guidance on Bioavailability and Bioequivalence Samples

FDA published guidance regarding the development of treatments for acute myeloid leukemia.

Developing Drugs to Treat Acute Myeloid Leukemia

The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

Sanofi to Acquire Principia Biopharma for $3.68 Billion

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01. 

Cobra Biologics Develops Master Cell Banks for CombiGene’s Gene Therapy

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer. 

FDA Publishes Guidance on Drug Development for Male Breast Cancer

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Samsung Biologics Expands Manufacturing Facilities and Launches Cell Line Technology

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

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