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FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.