BioPharm International Editors

The companies will collaborate on mRNA-based cancer vaccine development.

CRT and SV Life Sciences launched Artios Pharma, a new company formed to develop drugs targeting the DNA damage response to cancer.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

Adaptimmune entered into a manufacturing agreement with PCT for the manufacture of its SPEAR T-cell therapies.

CPhI outlines trends from the conference in Seoul.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Bayer will acquire the agricultural company for $66 billion in an all cash transaction.

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.

Allergan will acquire Vitae pharmaceuticals for $639 million.

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

Catalent will acquire Pharmatek, a San Diego-based manufacturer of oral, injectable, and topical products.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

The companies launched Onduo, a joint venture focused on developing solutions to assist patients with Type 2 diabetes.

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.

The company established a dedicated research center in Bangalore, India for Amgen.