FDA Lifts Partial Hold on Arcellx’s Multiple Myeloma Trial After Patient Death 8/15/2023

Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ELREXFIO™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

FDA Delays PDUFA Date for Valneva’s Chikungunya Shot 8/14/2023

FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer 8/14/2023

Pfizer Lawsuit Seeks to Block Generic Copy of Heart Disease Blockbuster 8/14/2023

The Neuropsychiatric Pipeline: 10 Late-Stage Therapies to Watch 8/14/2023

FDA Action Alert: Ipsen, Revance, Neurocrine and Regeneron 8/14/2023

Launch of Insilico’s Phase II Program Highlights Generative AI Momentum 8/14/2023

FDA Puts 2seventy bio’s CAR-T Trial on Formal Hold After Patient Death 8/14/2023

A collaborative study undertaken by the Navarrabiomed Biomedical Research Center (Pamplona, ​​Navarre), the Institute of Neurosciences CSIC-UMH (Sant Joan d'Alacant, Valencian Community) and IRB Barcelona (Barcelona, ​​Catalonia) shows that the administration of ranolazine, a drug currently used to treat heart conditions, improves the efficacy of current therapies for melanoma, in mouse models of this disease.

Bayer today announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). The data reinforce sustained vision gains with unprecedented extended treatment intervals of aflibercept 8 mg reaching up to 24 weeks with efficacy and safety comparable to the current standard of care Eylea™ (aflibercept 2 mg) with fixed intervals of 8 weeks.

In the ongoing search for a cure for Alzheimer's disease, a burgeoning branch of medicine is bringing new hope. Stem cell therapies are already being used to treat various cancers and disorders of the blood and immune system. In a new proof-of-concept study, scientists at University of California San Diego show stem cell transplants may also be a promising therapeutic against Alzheimer's.

AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge 9/8/2023

Week in Review: Astellas Withdraws IRA Lawsuit, New Illumina CEO and More 9/8/2023

Seagen, Nurix Team to Create New Class of Antibody Conjugates for Cancer 9/8/2023

AbbVie’s Humira to Take Hit from Biosimilars, Next-Gen Therapies: Report 9/8/2023

Otsuka, Shape Ink Potential $1.5B Deal to Develop Eye AAV Gene Therapies 9/8/2023

An antibody in single-chain fragment variable (scFv) format that binds to the powerful opioid carfentanil was shown to reverse signs of carfentanil overdose in preclinical tests conducted by scientists at Scripps Research.

Carfentanil is a variant of the synthetic opioid fentanyl, and about 100 times as potent as its chemical cousin.

The U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.

​Astellas Partners with Kate Therapeutics in Gene Therapy, After Four Patient Deaths in Previous ... 6/8/2023