BioPharm International Editors

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Fresenius Kabi enters biosimilars market with acquisition of Merck KGaA’s Biosimilars Business

GSK invests $139 million to expand production capacity for Benlysta (belimumab) in Rockville, MD.

Avid, a wholly owned subsidiary of Peregrine Pharmaceuticals, will upgrade its Myford, California clinical and commercial manufacturing facility with multiple Mobius 2000-L single-use bioreactors from MilliporeSigma, the companies announced on May 1, 2017.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

April 24–30, 2017 is European Immunization Week in Europe, and in a statement on the European Medicines Agency (EMA) website dated April 25, 2017, Executive Director Guido Rasi stressed the importance of vaccinations in preventing and controlling disease. Rasi acknowledged that fear created from incorrect information presented by unreliable sources has created a lack of trust in vaccines. But he highlighted that Europe monitors and records information on the safety of medicines, including vaccines.

United BioPharma Inc (UBP) has selected GE Healthcare’s FlexFactory manufacturing platform for its new facility focusing on late-stage clinical and commercial production capacity of therapeutic monoclonal antibodies in Hsinchu Industrial Park, Taiwan, the company announced on April 25, 2017. With this added capacity, UBP will support local healthcare needs by bringing biopharmaceuticals to the Taiwanese and surrounding markets faster.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

A new study from the United States National Institutes of Health (NIH) found that pairing the antidepressant amitriptyline with drugs designed to treat central nervous system diseases, enhances drug delivery to the brain by inhibiting the blood-brain barrier in rats. The blood-brain barrier serves as a natural, protective boundary, preventing most drugs from entering the brain. The research, performed in rats, appeared online April 27, 2017 in the Journal of Cerebral Blood Flow and Metabolism.

Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.

The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The company said it plans to invest $130 million in the United States and the United Kingdom to increase production capacity.

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

BMS is licensing two investigational compounds in separate deals with Roche and Biogen for a total of $470 million in upfront payments.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The agency cited the company’s India facility for batch failures and data integrity problems.

The company announced the expansion of its global shipping program, which now allows companies to ship dangerous goods between 36 countries.

The conference has partnered with Mercy Ships, a non-profit organization using hospital ships to deliver health care to developing nations.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

MilliporeSigma’s new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.