Drug Development

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

This move is expected to stimulate the exploration of many more medicines for use in children.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

FDA releases a report that analyses why some diseases are lacking treatment options.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

Modern methods and modeling offer a better way to understand solubility issues and solve today’s complex formulation challenges.

Prodrugs and drug-delivery systems controlled by time, pH, and osmosis, are being used to prevent drug degradation in the stomach and large intestine and ensure drug release in the colon.

With the French pricing and reimbursement policies becoming increasingly stringent, pharmaceutical manufacturers must adapt their drug development and commercial strategies if they want to secure premium pricing for their new products.

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

The new column features Natrix’s signature macroporous hydrogel.