Pharmaceutical Technology Editors

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.

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.

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.

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.

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.

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.