BioSpace News Archive

FDA

AbbVie Secures Full FDA Approval for ADC Elahere in Ovarian Cancer

AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.

March 25, 2024
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2 min read
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Tristan Manalac
Deals

AbbVie Acquires Landos in Potential $212M Deal, Bolsters Anti-Inflammatory Pipeline

Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio.

March 25, 2024
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1 min read
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Kate Goodwin
FDA

J&J Wins FDA Nod for Pulmonary Arterial Hypertension Combo Pill

Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.

March 25, 2024
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2 min read
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Tristan Manalac
Deals

Novo’s $1.1B Cardior Buy Continues Expansion into Heart Disease

Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.

March 25, 2024
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2 min read
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Tristan Manalac
FDA

Esperion Targets Seven-Fold Jump in Cholesterol Drug Population with FDA Label Expansion

Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.

March 25, 2024
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2 min read
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Nick Paul Taylor
Policy

FDA Authorizes Invivyd’s Pemgarda to Prevent COVID-19 in Immunocompromised People

The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.

March 25, 2024
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2 min read
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Tristan Manalac
Career Advice

Webinar: Navigating a Competitive Job Market

Join us in this discussion on how you can optimize your chances of landing a new role despite a highly competitive job market.

March 25, 2024
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1 min read
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Chantal Dresner
Drug Development

FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma

Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.

March 25, 2024
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2 min read
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Tyler Patchen
Pharm Country

NRx Pharmaceutical’s (NASDAQ:NRXP) Chairman Dr. Jonathan Javitt to Present at the Ketamine 2024 Conference in Oxford, UK

NRx Pharmaceuticals, Inc. today announced that Dr. Jonathan Javitt , Chairman and Chief Scientist of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics, will present at the Ketamine 2024 Conference, which is planned for March 25-27, 2024.

March 25, 2024
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5 min read
Pharm Country

Senseair Releases New Module, S88, for Advanced CO2 Monitoring

Senseair, a subsidiary of Asahi Kasei Microdevices Corporation (AKM), has announced the launch of the Senseair S88.

March 25, 2024
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3 min read