Drug Development

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

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.