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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.

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act.

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

CPhI Pharma Awards’ panel doubles in size and welcomes experts from around the world.

A new study reveals a potential new approach to treat sickle cell disease and beta thalassemia using CRISPR-Cas9 gene-editing technology.

Mallinckrodt announced a planned merger agreement with Stratatech Corporation, a regenerative medicine company.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The EDA offered Allergan tax credits in order to encourage the company to remain in the state.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

Zika vaccine development is hindered by technical challenges and funding shortfalls.

The company announced that Bioverativ will be the name of its new hemophilia spin-off business, which is expected to launch in early 2017.

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The company is voluntarily recalling one lot of product due to particulate matter.