Massachusetts
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Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia
2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.
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EyePoint Pharma Sells U.S. Rights to Eye Med to Become Pure Play Drug Developer
By selling U.S. rights to Yutiq, EyePoint Pharmaceuticals gets $75 million cash to support its drug pipeline. The company’s lead product candidate is in mid-stage development for wet age-related macular degeneration and non-proliferative diabetic retinopathy.
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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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New Flagship Startup Metaphore Mimics Mother Nature for Drug R&D
Metaphore Biotechnologies leverages the concept of biomimicry for developing new drugs with potential applications in autoimmune diseases, metabolic disorders, and cancer. Flagship Pioneering is backing the startup with $50 million.
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Startup Nido Bio Reveals $109M (so far) for Precision Approach to Neuro Disorders
Nido Biosciences’ lead drug hits a previously undrugged pocket as a way to potentially treat the rare neuromuscular disorder spinal and bulbar muscular atrophy. The startup’s tech platform screens neurons to find targets for new neurological disorder drugs.
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Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy
Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy.
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Orbital Therapeutics Raises $270M to Bring RNA-Based Medicines to New Heights
ARCH Venture Partners-backed Orbital Therapeutics’ is researching next-generation RNA medicines that offer advantages over currently available therapies. The startup’s three areas of focus are vaccines, protein replacement, and immunomodulation.
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Biogen Drug Wins Accelerated FDA Nod for Treating Rare Genetic Form of ALS
The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS.
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Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold
A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.
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Devices & Diagnostics, BioPharma
Neuro Startup Cognito Corrals $73M as Alzheimer’s Device Commences Key Test
Alzheimer’s disease research at MIT spawned Cognito Therapeutics, a startup whose medical device uses light and sound to modulate electrical activity that supports brain health. The company’s Series B financing will support a Phase 3 test of its technology in patients with mild-to-moderate disease.
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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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Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission
Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.
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Flagship Startup Emerges With $50M to Send Drugs to the Right Biologic Address
Ampersand Biomedicines emerged from stealth with technology for site-specific drug delivery that avoids toxic effects throughout the body. The Flagship Pioneering-founded startup is backed by $50 million in financing.
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FDA Halts Fulcrum Trial, the Latest Setback in a Week of Sickle Cell Stumbles
Fulcrum Therapeutics offered few details about the clinical hold the FDA placed on its Phase 1b test of its sickle cell disease drug. Graphite Bio, Intellia Therapeutics, and Sangamo Therapeutics also encountered setbacks to their sickle cell programs.
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Moderna Signs On a New Partner in Quest for In Vivo mRNA Gene Editing
Moderna is partnering with Life Edit, a subsidiary of ElevateBio that offers a suite of gene-editing technologies. The deal brings together the capabilities of both companies, which aim to develop in vivo gene-editing therapies.Mod
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Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy
The FDA approved Apellis Pharmaceuticals’ Syfovre as a treatment for geographic atrophy, a retinal disorder that is a leading cause of blindness. The drug, administered as an injection into the eye, will launch in March at the price of $2,190 per vial.
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Frequency Therapeutics Regenerative Med for Hearing Loss Fails Again in Phase 2
Frequency Therapeutics said its hearing loss drug candidate failed to beat a placebo in its second mid-stage clinical trial. The biotech is now focusing its regenerative medicine platform on the development of a multiple sclerosis drug not expected to reach the clinic until next year.
Promoted
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.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
