Clinical Trials
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BMS Cancer Drug’s New FDA Nod Puts It on Path to Reach Blockbuster Status
Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.
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Bayer Pushes Ahead With Parkinson’s Cell Therapy on Heels of Positive Phase 1 Data
A Bayer cell therapy for Parkinson’s disease has met primary and secondary goals of its first test in humans, and the pharmaceutical giant is now planning for a larger Phase 2 clinical trial expected to begin enrollment in the first half of next year.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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MedCity Pivot Podcast: A Conversation With Unlearn.AI CEO About Clinical Trials
The founder and CEO of Unlearn.AI seeks to make clinical trials more efficient and less costly by leveraging its Digital Twin technology. If the company is successful, drugs could potentially be brought to market sooner and in a cost effective manner.
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Precision Bio Offloads Lead Cell Therapy Program in Pivot to In Vivo Gene Editing
Imugene gains global rights to Precision BioSciences’ most advanced program, an allogeneic cell therapy for advanced cases of blood cancer. Precision will now focus on in vivo gene editing therapies, some of which is partnered with Novartis and Eli Lilly.
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Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug
Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.
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Harmony Bio’s Zynerba Buyout Brings Cannabinoid That Doesn’t Spark Euphoria
Zynerba Pharmaceuticals’ lead drug candidate is designed to bring the therapeutic effect of cannabinoids without also causing euphoric effects. The synthetic cannabinoid in a topical gel formulation includes none of the psychoactive compounds from the cannabis plant.
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FDA Approves J&J Combo Drug for Prostate Cancers With Certain Genetic Signature
Johnson & Johnson’s Akeega is approved for treating advanced prostate cancer with a BRCA mutation. The drug, which interferes with a way cancer cells repair themselves, will compete against recently approved drugs from Pfizer and partners AstraZeneca and Merck.
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Novo Nordisk Aims to Succeed Where Sanofi Faltered Drugging a Weight-Loss Target
Novo Nordisk isn’t putting all of its weight loss drug hopes in the same basket. Its acquisition of Inversago Pharma for up to $1 billion will bring a biotech whose lead drug candidate has early clinical trial data showing significant weight loss.
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J&J Broadens Scope in Multiple Myeloma, Winning FDA Approval for New Drug
Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Nektar Sues Eli Lilly, Claiming the Big Pharma Breached Contract to Favor Another Drug
“Botched math” in calculating clinical data for an autoimmune disease drug is one of the allegations Nektar Therapeutics makes in a legal complaint against Eli Lilly. The biotech claims its former partner tried to disadvantage the asset in order to advance development of another drug it acquired in a billion dollar deal.
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Novo Nordisk’s Wegovy Posts Trial Data Supporting the Drug as Way to Lower Heart Risks
Novo Nordisk weight-loss drug Wegovy reduced the risk of major cardiovascular events by 20% in a large clinical trial. The company said the results support expanding the drug’s label, but the looming question is whether the data will persuade payers to cover the pricey chronic therapy.
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Novel Social Anxiety Disorder Drug’s Data Relieve Stress on a Beleaguered Biotech
Vistagen Therapeutics’ fast-acting nasal spray drug, fasedienol, hit primary and secondary goals of an abbreviated late-stage study in social anxiety disorder. Vistagen’s stock price rocketed skyward on the results, which support progression to another Phase 3 study.
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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
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The Evolution of Patient-Centered Clinical Trial Design
Clinical trial design will be one of the topics discussed at the upcoming INVEST Digital Health conference in Dallas on October 26. THREAD Clinical Trial Design Director Noah Goodson highlighted some of the milestones the sector has seen in recent years.
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Drug and Digital Technologies Are Part of NIH’s Long Covid Clinical Trial Plans
Long Covid continues to afflict patients and mystify clinicians. The National Institutes of Health is trying to identify potential treatments and it is launching a series of clinical trials that will assess a wide range of therapeutic interventions.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
