Development

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

The biopharma industry is seeing more merit in strategizing clinical and commercial drug development as early as the preclinical phase.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

The $691 million deal will see Vertex use Mammoth’s systems to discover and develop in-vivo gene-editing therapies.

The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.

Spectrum Chemical scientists give a shout-out to 10 chemicals impacting quality of life in conjunction with National Chemistry Week.

Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

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.