Pharmaceutical Technology Editors

The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast. It will also be the base for reaching new customers in the area.

The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.

South East Asian pharma manufacturers seeking region growth expected to attend CPhi South East Asia.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

The company is voluntarily recalling product due to particulate matter.

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards program announced its 2017 category award winners.

The warning letter cited GMP violations for finished drug products.

Companies were recognized for their innovative packaging technologies.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of cGMP for finished pharmaceuticals.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland. On Jan. 26, 2017 Almac Group announced that as part of its ongoing global expansion, the company has secured a new facility in Dundalk, County Louth, Ireland. The new facility will be located at IDA Business Park. The new facility will increase the group’s European footprint by 32,000 ft2. The Dundalk facility will be utilized by Almac Pharma Services and Almac Clinical Services.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.

Local manufacturing, regulatory strategies, market entry, and harmonization to be featured at CPhI Istanbul.

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.