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Compass Pathways Seeks Director for U.S. Site of Care to Advance Psilocybin Therapy for PTSD

Compass Pathways Seeks Director for U.S. Site of Care to Advance Psilocybin Therapy for PTSD

Compass Pathways, a biotechnology company headquartered in London with a U.S. office in New Jersey, is actively developing COMP360 psilocybin, an investigational treatment for Post-traumatic Stress Disorder (PTSD) and treatment-resistant depression (TRD). COMP360 has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for TRD. The company is currently executing a late-stage trial for COMP360 in PTSD and is seeking a Director, National Site of Care in the United States. This role is crucial for establishing strategic relationships with organized care groups, health systems, and treatment centers that will serve as early adopters of COMP360 therapy. The Director will lead a team responsible for site-of-care execution, ensuring consistent account planning, customer engagement, and launch readiness activities across the U.S.
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Takeda's MIMRYLO™ (rusfertide) Approved by U.S. FDA for Polycythemia Vera Erythrocytosis

Takeda's MIMRYLO™ (rusfertide) Approved by U.S. FDA for Polycythemia Vera Erythrocytosis

Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution and red blood cell overproduction, aiming to control hematocrit levels. Maintaining hematocrit below 45% is the primary treatment goal for PV patients to prevent life-threatening thrombotic events. The approval is supported by data from the global randomized Phase 3 VERIFY study, which included 293 PV patients. The study showed that MIMRYLO, combined with standard of care, resulted in a higher response rate, reduced phlebotomy needs, and improved fatigue compared to placebo. MIMRYLO is administered once weekly via subcutaneous injection and was generally well-tolerated in trials, with common adverse events being injection site reactions and anemia.
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Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly

Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly

Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly
AP News AP News
Juul gets OK to sell updated vaping device with age-gating technology

Juul gets OK to sell updated vaping device with age-gating technology

E-cigarette maker Juul Labs has received U.S. permission to sell an updated version of its vaping device
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10x Genomics Launches Atera Platform for Whole-Transcriptome Spatial Analysis

10x Genomics Launches Atera Platform for Whole-Transcriptome Spatial Analysis

10x Genomics has introduced Atera, a new spatial platform designed to measure the entire transcriptome with single-cell sensitivity and at a significantly larger scale. This launch marks a continued expansion of 10x Genomics' focus on spatial biology, following its earlier contributions to the single-cell revolution. According to Serge Saxonov, co-founder and CEO of 10x Genomics, customer shipments for the Atera platform are anticipated to commence later this year. Saxonov emphasizes that spatial biology is evolving beyond a niche research area, becoming a crucial method for integrating molecular, cellular, and tissue-level insights. The company's strategy involves developing advanced tools for biological measurement and addressing biological questions by working backward from them, rather than being solely driven by specific technologies. This approach has also led 10x Genomics into proteomics, with a belief that binder-based methods currently offer the most effective path to scalability. Furthermore, the...
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BofA makes bullish call on newly public biotech stock

BofA makes bullish call on newly public biotech stock

Bank of America sees a differentiated opportunity in a breakthrough sleep apnea pill.
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Bank of America sees major upside in this biotech stock

Bank of America sees major upside in this biotech stock

A major Wall Street firm says a regulatory shift and coming launches could change the setup for one biosimilar developer.
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FDA Approves Mimrylo for Polycythemia Vera, First-in-Class Treatment

FDA Approves Mimrylo for Polycythemia Vera, First-in-Class Treatment

The U.S. Food and Drug Administration (FDA) has approved Mimrylo (rusfertide), a new treatment for adults diagnosed with polycythemia vera, a rare blood disorder characterized by the overproduction of red blood cells. This condition can lead to thickened blood and an increased risk of cardiovascular complications such as blood clots, stroke, and heart attack. Mimrylo represents a first-in-class therapy, targeting the biological mechanisms that drive red blood cell overproduction. It mimics hepcidin, a hormone that naturally regulates iron levels in the body, thereby limiting the iron available for new red blood cell formation. This novel approach offers a new option for patients whose disease has not been adequately controlled by existing treatments, aiming to reduce the burden of frequent phlebotomies.
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AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion

AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion

AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion
USA Today USA Today
FDA approves life-extending pancreatic cancer drug Rasonque

FDA approves life-extending pancreatic cancer drug Rasonque

The drug, called Rasonque, is a once-daily pill for people with pancreatic cancer who've received prior treatment, or can't get combination therapy.
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Cultivated Meat Industry Shifts Towards Integration and Pet Food Market for Commercial Viability

Cultivated Meat Industry Shifts Towards Integration and Pet Food Market for Commercial Viability

Cultivated Meat Industry Shifts Towards Integration and Pet Food Market for Commercial Viability
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AI-Driven Platforms Address Clinical Trial Bottleneck, Attracting Significant Investment

AI-Driven Platforms Address Clinical Trial Bottleneck, Attracting Significant Investment

AI-Driven Platforms Address Clinical Trial Bottleneck, Attracting Significant Investment