Early Phase Development

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.

HitGen has entered into a research service agreement with Nested Therapeutics for use of HitGen’s DNA-encoded library for drug discovery.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

The use of smart tools in early drug discovery can have an impact on downstream phases of drug development.

Decreasing vein to vein time saves lives.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

In vivo CAR-T gene therapies could resolve challenges faced by autologous and allogeneic treatments.

Although well known in R&D, PK/PD studies are an equally powerful tool for promoting successful biologic drug development.

Experts discuss factors that can affect the outcome of an ADME study, signs that a drug compound shows promise, red flags, and key parameters to determine safety and efficacy.

An early drug candidate screening strategy should incorporate clear targets to lessen late-stage failure.

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

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

Experts discuss what data to consider when selecting a high-potential drug candidate and how AI can be harnessed in medicinal chemistry drug discovery.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

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.

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.

UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.

A research collaboration will combine Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy.