The Role of RWD in Revolutionizing Clinical Trial Design
Using RWD to understand SDOH factors faced by patients with non-small cell lung cancer paves the way for improving health equity and more effective treatments for more people.
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Regeneron’s RNA Med for Muscle Disease Meets Trial Goals; FDA Filing Planned for Next Year
Cemdisiran, a small interfering RNA drug that Regeneron Pharmaceuticals licensed from Alnylam Pharmaceuticals, met the goals of its pivotal test in generalized myasthenia gravis. The rare neuromuscular disease has several new therapies, but analysts see cemdisiran as having advantages over one particular class of drugs.
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Discover the Most Effective Aquatic Therapy Programs in Chicago Suburbs
Incorporating aquatic therapy can enhance patient outcomes and shorten recovery times for health care professionals. In the Chicago suburbs, the demand for such programs is rising.
With a New Take on an Old Schizophrenia Drug, LB Pharma Prepares IPO to Fund Phase 3 Test
LB Pharmaceuticals’ planned IPO will fund late-stage clinical development of LB-102, a once-daily pill designed to improve on the old Sanofi schizophrenia drug Solian. The IPO filing follows a corporate restructuring in May that cut the jobs of LB’s chief financial and scientific officers to streamline operations and extend its cash runway.
First Therapy for Rare Tumor Is a Blockbuster Prospect, But Does Precigen Have the Cash to Make It Happen?
Precigen’s Papzimeos is the first FDA-approved drug for the rare disease recurrent respiratory papillomatosis, or RRP. While this immunotherapy carries blockbuster expectations, Precigen’s financial reports indicate budgetary challenges.
In Crowded Market for a Rare Disease, Ionis Bets Patients Will Switch to Its New First-in-Class Drug
The FDA approved Ionis Pharmaceuticals’ Dawnzera for preventing swelling attacks caused by the rare disease hereditary angioedema. A Takeda Pharmaceutical product dominates this market, but Ionis has clinical data showing patients had better outcomes after switching to Dawnzera from Takeda’s drug and other currently available HAE medications.
More Than 100 Organizations Back Bill to Expand Patient Access to Clinical Trials
A coalition of 131 healthcare organizations is backing the Clinical Trial Modernization Act, which aims to expand patient access to clinical trials through financial support and other measures.
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Price Transparency is the New North in the PBM World
In this episode hear how improving benefit verification, prior authorizations, and patient affordability with smart integrations and real-time eligibility can streamline healthcare workflows.
Jazz Pharma Broadens Its Prospects in Epilepsy With Deal for Selective Saniona Drug
Saniona’s drug candidate could expand Jazz Pharmaceuticals portfolio in epilepsy. But this preclinical small molecule will need to show advantages in safety and efficacy to compete with Biohaven Pharmaceuticals and Xenon Pharmaceuticals, each with clinical-stage drugs that hit the same epilepsy target.
Side Effects Make Viking’s Oral Obesity Drug a Tough Pill for Investors to Swallow
Viking Therapeutics’ obesity pill met weight reduction goals of its Phase 2 test, but gastrointestinal side effects led to high discontinuation rates. Even so, analysts see potential for a lower dose of the Viking drug as a maintenance therapy.
FDA Approval Expands Novo Nordisk’s Wegovy to the Fatty Liver Disease MASH
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s room for many MASH drugs with the treatment landscape expected to shape up to include combinations of therapies bringing different approaches to this fatty liver disease.
Pfizer Gets Another Dose of Disappointment as Sickle Cell Disease Drug Fails Pivotal Test
Pfizer’s inclacumab did not beat a placebo in a Phase 3 test in sickle cell disease. The trial failure comes nearly a year after Pfizer voluntarily withdrew Oxbryta from the market after tests showed higher rates of complications and deaths for that sickle cell disease drug.
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The Top EAP Companies for Mental Health Support
Employee assistance programs have become essential tools for organizations aiming to address mental health challenges, reduce burnout and foster healthier workplaces.
Response Pharma’s Novel Pill for Weight Loss Shows Promise as Post-GLP-1 Maintenance Therapy
Response Pharmaceuticals takes a new approach to weight loss with an oral small molecule designed to inhibit a protein called iMTP to reduce uptake of fats and cholesterol. While this drug’s lead indication is addressing weight gain in patients taking antipsychotics, the company is also exploring other metabolic indications such as patients who need a post-GLP-1 therapy.
Chronic Lung Disease in Medical Literature for More Than 200 Years Finally Has Its First Drug
Insmed’s Brinsupri is the first drug specifically approved for treating non-cystic fibrosis bronchiectasis, a progressive and potentially fatal lung disorder. The drug, licensed from AstraZeneca, inhibits activation of neutrophils, white blood cells that play a role in inflammatory and immune responses.
FDA Nod Makes Boehringer Ingelheim Drug an Alternative to AstraZeneca ADC in Lung Cancer
Boehringer-Ingelheim pill Hernexeos was awarded accelerated FDA approval for advanced cases of non-small cell lung cancer with HER2 mutations. But Bayer is on its heels with an oral small molecule currently under FDA review in the same indication.
Rare and Aggressive Brain Cancer Affecting Children Gets Its First FDA-Approved Drug
Jazz Pharmaceuticals’ dordaviprone, brand name Modeyso, is now the first FDA-approved therapy for recurrent H3 K27M-mutant diffuse midline glioma. The drug came from Jazz’s $935 million acquisition of Chimerix earlier this year.
Vertex Non-Opioid Pain Drug Flunks Proof-of-Concept Test, Ending Plans for a Pivotal Study
A next-generation Vertex Pharmaceuticals pain drug failed to beat a placebo in a Phase 2 clinical trial. Despite the disappointing outcome in bunionectomy pain, the company is continuing development of the oral drug in diabetic peripheral neuropathy.