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
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
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
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
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
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
Toyoda Gosei Invests in Yuurea, Inc., a Startup Developing Urine Test Kits for Easy Checks of Physical Condition

Toyoda Gosei Co., Ltd., as one part of its efforts to develop new businesses that will help to resolve societal challenges in the healthcare field, has invested* in Yuurea, Inc., a company that develops test kits which will allow people to monitor their physical condition simply, using urine samples.

March 25, 2024
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1 min read
Business

ProKidney Announces Key Leadership Appointments Strengthening Clinical and Technical Operations

ProKidney Corp. announced two recent strategic appointments enhancing the leadership team’s expertise in clinical operations and technical operations, positioning the Company for completion of its Phase 3 program and future commercialization.

March 25, 2024
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6 min read