News

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

The chemical distribution industry has formed an international chemical trade association to address global issues.

Can the feds negotiate Medicare Part D prices?

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

Amgen announces FDA will review the company’s BLA for ABP 501.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Vetter announces completion of multi-functional building for development service and IT functions.

Siemens and ADENTS develop joint solution for drug serialization challenges.

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.

The new website, dubbed “Integrated Solutions”, helps clients implement single-use solutions and hybrid biomanufacturing processes.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

GS1 US announces the expansion of its advisory services program to address industry needs.

The Foundation for AIDS Research awarded each of two scientists nearly $1 million in grants for research into eradicating the viral vector.

Austrianova completes facility for GMP cell banking and fill/finish services for cell therapy products.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

Colorcon acquires Paulaur Corporation, a manufacturer of specialty sugar-based ingredients.

SGS Life Sciences expands chemistry and microbiology testing services after acquisition of Quality Compliance Laboratories.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.