Development

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

Industry representatives sound off on FDA’s FARS report, released in January this year.

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

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

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.

The complexity of newer biotherapeutic molecules calls for alternative drug delivery strategies.

Speed-to-market, capacity, technology development, and increased investment top the list.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

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

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.

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 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.

The research collaboration between AstraZeneca and VaxEquity aims to discover and develop self-amplifying RNA therapeutics.

Celularity and Oncternal’s collaboration will focus on therapeutics targeting Orphan Receptor 1, which is linked to aggression and survival in solid tumor cells.