Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

Boehringer Ingelheim and China Southeast University announced a joint research collaboration to develop new regenerative treatments for hearing loss.

The UK’s NICE recommended pembrolizumab for the treatment of patients with advanced lung cancer, reversing the institute’s earlier decision.

Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure’s bacterial vaginosis treatment.

The company opened a new facility in Dublin for its cell performance technology.

Vetter’s Ravensburg data processing center received certification from a German industrial testing organization, certifying that the company’s customer and process data are protected.

WMFTG acquired Aflex Hose adding polytetrafluoroethylene-lined flexible hoses to its fluid path product portfolio.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Rookie API developers beat pharma at its own game.

Europe-based bio/pharma employees are unified on satisfaction with employment conditions-and dissatisfaction with salaries.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

Mylan signed a sub-license agreement with the Medicines Patent Pool to develop a generic version of daclatasvir to market in developing countries.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.

Domestic sales will be the key driver of revenue growth.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Spanish CRO, Kymos Pharma Services, announced that it has acquired Pharmaprogress, an Italian firm based in Ancona, specializing in contract research and analysis services.