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.

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.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

Health Canada approved AbbVie’s Humira for the treatment of adults with hidradenitis suppurativa.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

Baxter voluntarily recalls two lots of intravenous solutions due to particulates.

Jones Packaging and ThinFilm will collaborate on NFC OpenSense technology for pharmaceutical packaging.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

More “me-betters” and more focused breakthroughs could enhance new drug development.