Development

FDA’s priority review status was granted based on positive results from a Phase III study evaluating Sarclisa in combination with VRd in treating transplant-ineligible newly diagnosed multiple myeloma.

Under an agreement, Johnson & Johnson will acquire Numab Therapeutics’ wholly owned subsidiary to gain global rights to NM26, a bispecific antibody targeting atopic dermatitis.

The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.

Webinar Date/Time: Thu, Jun 20, 2024 10:00 AM EDT

An ASGCT Panel titled Novel Nucleic Acid and Cell-based Vaccines for Cancer highlights promising mRNA personalized cancer vaccine work.

Under this partnership, AGC Biologics and BioConnection will provide development and manufacturing capabilities for biopharmaceutical drug substance and drug product.

Biogen’s acquisition of HI-Bio includes lead investigational mAb, felzartamab, under development for treating a range of immune-mediated diseases.

Webinar Date/Time: Tue, Jun 18, 2024 10:00 AM EDT | 4:00 PM CEST

Regeneron’s Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, gave insight into how the biopharma industry views the application of AI in R&D.

In an interview with BioPharm International® during the US Pharma and Biotech Summit, Ken Keller, president and CEO, Daiichi Sankyo, discusses what makes a good foundation for partnerships in the bio/pharmaceutical industry.

The company presented results from its programs for Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy.

Webinar Date/Time: Thu, Jun 13, 2024 11:00 AM EDT

Regeneron’s work in CAR-T cell therapy development includes engineering receptor architecture to improve CAR-T cell sensitivity and improve immune response.

Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, Regeneron spoke about the use of bispecific antibodies to retarget AAV specificity.

Broken String Biosciences and the Francis Crick Institute will collaborate on research into how genome stability impacts ALS.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

The collaboration will target solid tumors using Poseida’s allogeneic CAR-T platform to develop convertibleCAR programs.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.

Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.

Webinar Date/Time: Tue, May 14, 2024 1:00 PM EDT

Webinar Date/Time: Tue, Jun 11, 2024 10:00 AM EDT

This article represents a comprehensive exploration about biopharmaceutical excipients, exploring their multifaceted classification, active role in drug formulation processes, inherent challenges, and upcoming advancements poised to revolutionize the drug formulation and its efficacy for patient welfare.