News

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.

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.

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

Pfizer will acquire Medivation for approximately $14 billion.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.