News

Pharma packaging manufacturer Sanner has expanded capacity at its site in Budapest, Hungary.

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.

Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.

Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

The acquisition will support Novo Nordisk’s development of glucose-responsive insulins.

FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.

The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

King Bio is recalling several of its kids and infant products due to possible microbial contamination.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.

The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

The company’s purpose-built facility in Norwich, United Kingdom specializes in plant-based expression of proteins, metabolites, and complex natural products.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.

FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.