Pharmaceutical Technology Editors

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

The EXcell 231 and EXcell 241 sensors from EXNER Process Equipment have updated software and connection features for improved flexibility and safety.

The company is voluntarily recalling the product due to difficulties with the delivery system.

NHS England and three pharma companies have agreed to work together to find and cure tens of thousands more people with hepatitis C, potentially leading to Britain becoming the first country to eliminate the virus.

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.

The UK’s General Pharmaceutical Council (GPhC) has strengthened its guidance for online pharmacies to further safeguard patients when purchasing medicines.

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

The investment will increase patient-centric dosage form manufacturing capabilities at Catalent’s Winchester, KY, facility.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.

Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.

Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.

Sterling Pharma Solutions has been granted a Queen’s Award for Enterprise in the field of International Trade.

Biocatalysts, a global biotechnology company, has announced it has been named as one of the winners of the Queen’s Awards for Enterprise in Innovation.

Start Codon strategic initiative has been launched, aimed at providing a life-science accelerator that offers funding and support to translate innovative research into start-up companies.

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

Eli Lilly sold rights to two of its legacy antibiotics as well as its Suzhou, China, manufacturing facility, to China-based specialty pharmaceutical company Eddingpharm in a deal worth $375 million.

Expansion at the Eberbach, Germany facility includes two Vegicap encapsulation lines, printing, inspection, and packaging capabilities.

Expansion at GSK’s Hamilton, MT site is designed to boost vaccine production capacity.