Drug Development

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

In this episode, Fernando Muzzio provides greater insight into a novel approach to improving drug solubility—continuous melt coating.

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Single-cell analytical technologies can deepen the understanding of cell biology and, therefore, disease mechanisms.

Lack of toxicity data and poor physicochemical properties must be overcome.

Pharma should expand on successful cell therapies in oncology by applying these development and manufacturing methods to neuronal cell therapies.

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.

Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.

GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

Precision BioSciences has released clinical trial data on CAR T therapy candidates PBCAR0191, PBCAR19B, and PBCAR269A.

Thermo Fisher Scientific and Qatar Genome Program will use custom genotyping arrays to accelerate genomic research in Qatar.

Putting the patient at the forefront of drug development is essential, particularly to ensure medication compliance is optimized.

The right processes used with the right excipient combinations address evolving formulation needs.

Collecting relevant data, planning ahead, and communicating with regulatory bodies in pre-IND meeting programs can help companies to avoid roadblocks in IND applications.