Sun.Mar 24, 2024

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Epigenetic Editing Explodes on the Heels of Gene Editing Success

BioSpace

Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.

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Eisai and Biogen facing delay to Leqembi in Europe

pharmaphorum

Eisai and Biogen are facing a delay in the review of their Alzheimer's therapy Leqembi in the EU, for "procedural" reasons

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Opinion: ALS Is Not a Singular Disease. Stop Treating It Like One

BioSpace

Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?

Drugs 139
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Inappropriate Diagnosis of Pneumonia Among Hospitalized Adults

JAMA Internal Medicine

This cohort study characterizes inappropriate diagnosis of community-acquired pneumonia among hospitalized patients in 48 Michigan hospitals.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Merck, Others Look to Immunotherapy Combos as Next Frontier in Oncology

BioSpace

Drugmakers are testing a variety of biologics and small molecules in conjunction with therapies aimed at modulating the immune system to target and destroy cancer cells.

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Fatal Traffic Risks With a Total Solar Eclipse in the US

JAMA Internal Medicine

This case-control study describes the incidence of fatal traffic crashes in the US during the 2017 total solar eclipse.

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Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract p

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

BioSpace

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.

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Which drugs have supplementary protection certificates in the most countries?

Drug Patent Watch

This chart shows the drugs with the most supplementary protection certificates (SPCs).

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Wegovy Cardiovascular Approval Furthers March into New Indications

BioSpace

The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.

Drugs 103
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Effectiveness of an AI–Enabled Intervention for Detecting Clinical Deterioration

JAMA Internal Medicine

This cohort study examines whether the use of an artificial intelligence–enabled deterioration model is associated with a decrease in the risk of escalations in care in hospitalized patients.

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

BioSpace

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.

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

BioSpace

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.

Drugs 89
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FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma

BioSpace

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

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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

BioSpace

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.

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