Drug Development

Between dosage form versatility, product stability, lack of storage restrictions or need to refrigerate, and an easier means of purification, small-molecule APIs present an appealing market niche.

Pharmalex has launched the Biopharma Excellence brand, a new service line that combines the expertise of PharmaLex, ERA Consulting, and Biopharma Excellence.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.

The Pharmaceutical Technology and BioPharm International editors host industry experts, highlighting trends and new technologies.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, signed an agreement with Cellecta to license its genome-editing tool.

Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.

New excipients for protein-based drug products reduce viscosity while maintaining protein stability.

The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.

Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.

Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.

Reformulation strategies are useful tools for more than just stretching out the potential return on investment for a product.

Drug makers are going beyond continuous improvement and green chemistry to increase the sustainability of small-molecule manufacturing.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

Change of roster does not change the goal line. We are all patients first.

Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.

Novartis and Medicines for Malaria Venture have reported positive results from the Phase IIb study, evaluating a new non-artemisinin combination to treat uncomplicated malaria in children.

ViiV Healthcare has presented three-year clinical trial, reinforcing that the two-drug regimen Dovato can be used as a viable switch option for people living with HIV.

In September, Codex DNA released a full-length synthetic genome for the SARS-CoV-2 delta variant, which may accelerate discovery and development of diagnostics and treatments for COVID-19.

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.