News

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.

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.

ISPE announced the results of its 2016–2017 International Board of Directors election.

The merger of Avantor Performance Materials and Nusil Technology positions the company for growth in bioprocessing.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

GE and Sealed Air extend their long-term collaboration to develop single-use films purposefully constructed for bioprocessing applications.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.