For Many, CAR T is a Miracle Therapy – We Need to Get it to More Patients
To truly expand CAR T access and prepare for the wave of new T cell-based therapies coming through the pipeline, we must find better ways to manage CRS and ICANS.
Roche’s Metabolic Drug Strategy Extends to the Liver Disease MASH With $2.4B 89bio Acquisition
Roche is buying 89bio to get pegozafermin, a drug currently in two Phase 3 studies for the fatty liver disease MASH. Beyond the $2.4 billion payable when the deal closes, another $1.1 billion in contingent value right payments is tied to the achievement of commercial milestones for the projected blockbuster seller.
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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.
Novartis Adds to Its Immunology Prospects With Another Deal for Monte Rosa’s Molecular Glue Drugs
Novartis is paying $120 million up front to secure rights to a Monte Rosa molecular glue degrader drug candidate as well as options for two others. The two companies began working together last year under an alliance focused on immune mediated-diseases.
Maze Therapeutics Drug Shows Potential to Top Asset Acquired by Otsuka for $800M
With positive Phase 1 results for the metabolic disorder drug MZE782, Maze Therapeutics plans to advance the small molecule to Phase 2 tests in phenylketonuria and chronic kidney disease. Following the data readout, Maze raised $150 million in a private placement.
How Pharma Marketers Can Prepare for Trump’s 200% Tariff Threat
Putting aside the politics of this situation for the moment, here are some ways for commercial execs to navigate the current climate of volatility.
Long Regulatory Saga for Intercept Pharma Liver Drug Ends a Decade After Speedy FDA Approval
Intercept Pharmaceuticals is voluntarily withdrawing from the market Ocaliva, a drug for the rare liver disease primary biliary cholangitis. While Ocaliva became an important new treatment option when it won accelerated FDA approval in 2016, PBC patients now have new FDA-approved medicines from Ipsen and Gilead Sciences that don’t pose the same safety risks.
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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.
FDA Nod for J&J’s Drug/Device Treatment Gives Bladder Cancer Patients Another Option
A Johnson & Johnson cancer treatment that can spare certain bladder cancer patients from the radical step of surgical removal of the organ now has FDA approval. J&J’s drug/device combination product, Inlexzo, came from the 2019 acquisition of Taris Biomedical.
Summit Lung Cancer Drug Falls Short on Key Survival Goal in Global Study, Putting FDA Approval in Doubt
Despite achieving statistically signficant improvement in progression-free survival in North American and European patients, Summit’s drug ivonescimab fell short of the other Phase 3 goal measuring overall survival. It’s the first Phase 3 readout for an emerging class of bispecific antibodies that treat cancer by blocking two targets, PD-1 and VEGF.
Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public
FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move complies with an executive order that covers the communication of scientific data.
Novo Nordisk Turns to Self-Replicating RNA Startup to Discover New Metabolic Medicines
Obesity and type 2 diabetes are among the cardiometabolic diseases included in Novo Nordisk’s R&D pact with Replicate Bioscience, a deal that could pay out up to $550 million. Startup Replicate specializes in therapies and vaccines based on self-replicating RNA.
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RCM Outsourcing: Balancing Human Expertise & Smart Technology
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
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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.
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.
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.
FDA Suspends Valneva Vaccine’s License Following New Reports of Adverse Events
Valneva must immediately cease U.S. shipments and sales of Ixchiq, a vaccine for chikungunya virus. The FDA recently lifted a pause on dosing of Ixchiq, but the agency’s new safety alert is based on an assessment that found the vaccine appears to be causing chikungunya-like illness in recipients.
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.