Key Takeaways MRK's NDA for its two-drug HIV pill DOR/ISL has been accepted by the FDA, with a decision due in 2026. DOR/ISL showed non-inferiority to current HIV therapies in two pivotal phase III studies. MRK continues HIV research with additional trials and a collaboration with GILD on islatravir combinations.Merck (MRK) announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-daily, oral, two-drug, single-tablet regimen of doravirin ...

Meanwhile, as we return to a new challenge against that controversial migrant detention facility in Florida, the one that's been dubbed Alligator Alcatraz, five Democratic Florida lawmakers have filed a lawsuit against Governor Ronda Santis and the Florida Department of Emergency Management, the executive director of that after they were denied access to the center. A Dantis representative said, quote, "The state is looking forward to quickly dispensing with this dumb lawsuit." Well, joining us now, Florida ...

Core Insights - Merus N.V. (MRUS) shares have increased by 29.9% over the past three months, driven by positive interim results from a phase II study of its bispecific antibody, petosemtamab (MCLA-158), in combination with Merck's Keytruda for treating PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1][4] Study Results - As of February 27, 2025, 45 patients were treated, with 43 deemed efficacy-evaluable, resulting in a confirmed overall response rate (ORR) of 63%, which included six complete responses and 21 partial responses [2] - The ORR varied with PD-L1 expression levels, showing a 73% ORR in patients with a combined positive score (CPS) greater than 20 and 47% in those with CPS 1–19 [2] - Median progression-free survival was reported at nine months, with an overall survival rate of 79% at 12 months [3] Safety Profile - The safety profile of the combination therapy was manageable, with no significant overlapping toxicities reported with Keytruda; treatment-related adverse events occurred in all patients, with infusion-related reactions observed in 38% [5][6] Future Prospects - The promising data suggests that the petosemtamab combination therapy could become a new standard of care for HNSCC, a cancer type with poor prognosis [6] - Merus is also conducting a registrational phase III study (LiGeR-HN1) for the combination therapy and another study (LiGeR-HN2) for petosemtamab monotherapy [7][8] Market Context - Merck's Keytruda, a leading anti-PD-1 therapy, generated $7.21 billion in sales in Q1 2025, reflecting a 6% year-over-year increase, and continues to expand into new indications and markets [8][10]

If you had to leave, do you worry that you would relapse. Yeah, I probably wouldn't live. Back in March, Fresh Start learned a federal grant for prevention and treatment of substance abuse was being eliminated by the Trump administration, part of more than a billion dollars in Department of Government efficiency cuts nationwide to streamline spending and consolidate public health programs.Campbell says they lost about a quarter of their budget. Were you worried that you might have to shut down. It's always ...

Core Insights - Cerevance is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases and obesity, with presentations scheduled at the Alzheimer's Association International Conference (AAIC) 2025 [1] Group 1: Upcoming Presentations - Cerevance will present a Phase 1 study on CVN293, an investigational inhibitor targeting NLRP3-mediated neuroinflammation, on July 28, 2025 [2] - Another presentation will focus on the NETSseq platform, revealing insights into astrocyte function in Alzheimer's disease, scheduled for July 30, 2025 [2] Group 2: NETSseq Platform - The NETSseq platform allows for the identification of subtle molecular changes driving disease progression by analyzing brain tissue from over 20,000 donors aged 8 to 104 [3] - This platform aids in identifying low-level expressed targets and rare cell types, enhancing the understanding of neurodegenerative diseases [3] Group 3: CVN293 Overview - CVN293 is a selective oral inhibitor of KCNK13, aimed at reducing neuroinflammation and potentially modifying disease progression in neurodegenerative disorders [4] - The mechanism of CVN293 may also provide therapeutic benefits for obesity, identified through the NETSseq platform [4] Group 4: Company Pipeline - Cerevance's lead investigational treatment, solengepras, is in Phase 3 development for Parkinson's disease, while CVN766 targets binge eating disorder and schizophrenia [5] - CVN293 represents a novel intervention point for both neurodegenerative disorders and obesity [5]

Core Insights - Zevra Therapeutics, Inc. announced presentations on MIPLYFFA (arimoclomol) at the NNPDF Conference, highlighting its role as the first FDA-approved treatment for Niemann-Pick disease type C (NPC) [1][2] - MIPLYFFA is indicated for use in combination with miglustat for treating neurological manifestations of NPC in patients aged 2 years and older [7][6] Presentation and Research Findings - Dr. Barbara K. Burton presented an overview of MIPLYFFA, emphasizing its unique mechanism that improves lysosomal function and halts disease progression at 12 months in a pivotal study [2][3] - The pivotal trial demonstrated that arimoclomol combined with miglustat halted disease progression compared to placebo, confirmed by a 48-month open-label extension study [4][6] - Two posters were presented: one detailing long-term effectiveness and safety of arimoclomol, and another providing mechanistic evidence of arimoclomol's action through the CLEAR network [4][5] Drug Mechanism and Clinical Significance - MIPLYFFA enhances the activation of transcription factors TFEB and TFE3, leading to the upregulation of CLEAR genes and improved lysosomal function [6][17] - The drug has shown to reduce unesterified cholesterol in NPC fibroblasts, although the clinical significance of this finding remains to be fully understood [6] Company Overview - Zevra Therapeutics focuses on developing therapies for rare diseases with limited treatment options, aiming to create transformational therapies through data-driven strategies [18]

The perils of bowing to those anointed as special https://t.co/NymR4YeDtb ...

SANTA ANA, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the administration of the first dose of troculeucel, an expanded autologous NK cell therapy, under a single compassionate use, Investigational New Drug (“IND”) authorization cleared by the U.S. Food and Drug Admini ...

Core Insights - Vor Bio has appointed Sandy Mahatme as Chief Financial Officer and Chief Business Officer, effective July 9, 2025, to support the company's transformation and growth in autoimmune disease treatment [1][3] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, particularly through the development of telitacicept, a novel dual-target fusion protein [5] - The company is advancing telitacicept through Phase 3 clinical development and aims to commercialize it for serious autoantibody-driven conditions worldwide [5] Leadership Experience - Sandy Mahatme brings over 30 years of executive leadership experience in the biopharmaceutical industry, with a strong track record in capital markets, business development, and global operations [2][3] - Prior to joining Vor Bio, Mahatme raised over $2.5 billion in equity and non-dilutive capital at National Resilience, Inc., and led capital formation efforts exceeding $3.5 billion at Sarepta Therapeutics [2][3] Strategic Importance - The appointment of Mahatme is seen as pivotal for Vor Bio as it advances telitacicept through global Phase 3 development and aims to improve the lives of patients with autoimmune diseases [3][5] - Mahatme's experience in navigating strategic growth in both private and public biotech settings is expected to be instrumental for the company's future [3] Inducement Plan - On July 9, 2025, Vor Bio granted Mahatme 13,882,750 restricted stock units (RSUs) as a material inducement to employment, with a vesting schedule over four years [7]

Right in the middle of the sweltering heat of the Florida Everglades, reports of mosquitoes the size of elephants, no water to clean yourself, and food that has worms in it. Those stomach churning details come from an inmate inside the new Florida immigration detention center known as Alligator Alcatraz. And this weekend, members of the Florida State Legislature and Congress will be able to go inside for the first time to see the facility for themselves.Joining me now is NBC South Florida's Hatelvella who h ...