Pharmaceutical Technology Editors

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.

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.

DSM Sinochem will expand production of 7-ADCA at its Delft facility to support growth in sustainable antibiotics.

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.

The company increased capabilities at its Pharmatek San Diego facility in response to market demand for solubility enhancement solutions.

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.

FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.

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.

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

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.

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

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 new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.

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

The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

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.

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.

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

Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.

Bosch’s new system for the production of water for injection uses membrane processing and ultrafiltration.

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

This platform is designed to give pharmaceutical professionals a deeper knowledge of excipient functionality, core formulation, film coating, and controlled release of oral solid dosage forms, along with regulatory insights.

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

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

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

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