Remove Events Remove Licensing Remove Treatment
article thumbnail

OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

FDA 111
article thumbnail

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
article thumbnail

Quercis Pharma Licenses Key Patents for Thromboembolism Platform Across Cancer and COVID-19 Indications

The Pharma Data

Patents Related to P-selectin Expand Patent Life for Quercis’ Investigational Drug to Prevent and Treat Venous Thromboembolism in Cancer Patients and for Prevention and Treatment of COVID-19. The patents cover the inhibition of soluble P-selectin that helps to prevent and/or reduce thrombotic events. ZUG, Switzerland , Jan.

article thumbnail

ACEP Applauds Removal of X-waiver, Expanding Medication-assisted Treatment for Opioid Use Disorder

The Pharma Data

Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.

article thumbnail

PharmaEngine, Inc. and Sentinel Oncology Limited Enter into an Exclusive Collaboration and License Agreement for SOL-578, a Chk1 inhibitor

The Pharma Data

TWO: 4162) announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578 , a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578. TAIPEI , Dec. ” said Yufang Hu , Ph.D.,

article thumbnail

New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

The Pharma Data

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). “We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.”