Early Phase Development

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The companies will partner to further immuno-oncology research using humanized mice.

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

A Takeda and Denali collaboration includes three named programs for treating Alzheimer’s disease and other neurodegenerative diseases, using Denali’s antibody transport vehicle (ATV) technology to enhance blood-brain barrier penetration.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

The contract research organization (CRO) has acquired Xenometrics, a non-clinical CRO specializing in preclinical assessment of new drug candidates.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.