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Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.

CPhI Worldwide announced new additions to its 2017 advisory board.

The company is expanding their April 2017 voluntary recall of phenobarbital tablets.

The agency released its report on pilot project to involve patients in the assessment of medicines.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

Biomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.

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 agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

Amgen is once again asking the court to weigh in on a patent infringement case. In March 2017, Sanofi and Regeneron asked a federal court to issue a declaratory judgment of non-infringement indicating that their drug Dupixent (dupilumab) does not infringe on Amgen’s ‘487 patent covering IL-4 inhibitors. Although the court has not yet responded to this request, in early April 2017 Amgen issued a complaint of patent infringement against Sanofi/Regeneron involving the same ‘487 patent.

Valeant’s Siliq (brodalumab) injection will be listed for $3500 a month in the United States, the company said on April 21, 2017. In a statement, Valeant said this makes Siliq the lowest-priced injectable biologic to treat psoriasis on the US market.