News

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.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

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 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.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

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.

Results of Phase III trials involving AbbVie’s blockbuster drug Humira (adalimumab) for the treatment of noninfectious uveitis were released on Sept 7, 2016. FDA approved the drug for noninfectious intermediate, posterior, and panuveitis in June 2016, bringing Humira’s list of approved US indications to 10.

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.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.

In Phase Ib trials, Biogen’s aducanumab reduced amyloid-beta in the brains of patients with Alzheimer’s disease.

SpacePharma will give US researchers access to microgravity solutions to advance R&D projects.