Pharmaceutical Technology Editors

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

BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.

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.

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.

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.

Merck KGaA, Pfizer, and Syndax enter into exclusive agreement to evaluate the use of avelumab and entinostat for ovarian cancer patients.

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.

Valeant announced its CEO, J. Michael Pearson, will be on medical leave of absence after being hospitalized for pneumonia.