BioSpace
MARCH 24, 2024
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.
pharmaphorum
MARCH 24, 2024
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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BioSpace
MARCH 24, 2024
Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.
JAMA Internal Medicine
MARCH 24, 2024
This cohort study characterizes inappropriate diagnosis of community-acquired pneumonia among hospitalized patients in 48 Michigan hospitals.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
BioSpace
MARCH 24, 2024
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.
FDA Law Blog
MARCH 24, 2024
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
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
JAMA Internal Medicine
MARCH 24, 2024
This case-control study describes the incidence of fatal traffic crashes in the US during the 2017 total solar eclipse.
BioSpace
MARCH 24, 2024
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.
JAMA Internal Medicine
MARCH 24, 2024
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.
BioSpace
MARCH 24, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Patent Watch
MARCH 24, 2024
This chart shows the drugs with the most supplementary protection certificates (SPCs).
BioSpace
MARCH 24, 2024
Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
BioSpace
MARCH 24, 2024
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.
BioSpace
MARCH 24, 2024
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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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
MARCH 24, 2024
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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