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.

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

FuelCell Energy plans to install a 5.6 megawatt fuel cell power generation system for Pfizer to provide reliable and low carbon electricity and steam for its 160-acre R&D facility in Groton, CT.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

Patheon announced the appointment of Gilles Cottier as president of the company’s pharmaceutical development services.

The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.

Takeda Pharmaceutical Company and enGene have entered into a strategic alliance to develop novel therapies for specialty gastrointestinal diseases.

Cell Therapy Catapult and Synpromics announced a collaboration to increase scale and efficiency of viral vector manufacturing.

Adimab and Merck have entered into a definitive agreement to transfer Adimab’s antibody technology to Merck Research Laboratories.

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

AstraZeneca and Moderna Therapeutics set to collaborate on mRNA therapeutic candidates for the treatment of cancer.

Novartis enters into alliance and licensing agreement with Surface Oncology.

Yokogawa announces the acquisition of Industrial Evolution, a cloud-based plant data-sharing service provider.

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

Charles River Laboratories entered into a definitive agreement to acquire WIL Research.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

SCORR Marketing and Applied Clinical Trials release the results of EU clinical trials survey.