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.

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.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.

Aesica Pharmaceuticals, a global pharmaceutical contract development and manufacturing organization (CDMO), announced the strategic relocation of development and clinical manufacturing services from Nottingham to Queenborough. The new development center at Queenborough has more than twice the capacity of the existing one in Nottingham.

The revised USP Chapter Sterile Product Packaging-Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.