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Mustang Bio Announces Publication in Nature Medicine of Data from Phase 1 Trial Evaluating MB-101 IL13Rα2-targeted CAR T-Cells in High-Grade Glioma

Retrieved on: 
Thursday, March 7, 2024
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WORCESTER, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced Phase 1 clinical data were published in Nature Medicine that demonstrated the promising safety and clinical activity of Mustang’s MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of patients with recurrent and refractory malignant glioma, including glioblastoma.

Key Points: 
  • MB-101 was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Mustang.
  • Central nervous system (CNS) increases in inflammatory cytokines, including IFNγ, CXCL9, and CXCL10, were associated with CAR T-cell administration and bioactivity.
  • Primary endpoints were safety and feasibility, with secondary endpoints measuring therapy-related cytokine dynamics, CAR T-cell persistence and clinical outcomes.
  • Dr. Brown has a financial interest in Mustang and has previously been a paid consultant for the company.

Fiverr Introduces Vetted Freelance Tax Consultants and Experts for U.S. Businesses to Tackle Tax Season

Retrieved on: 
Thursday, March 7, 2024
Headache, Consultant, Innovation, Organization

NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Fiverr International Ltd. (NYSE: FVRR), the company that is changing how the world works together, announced today the introduction of vetted freelance tax professionals for businesses navigating the complexities and headaches of tax season.

Key Points: 
  • NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Fiverr International Ltd. (NYSE: FVRR), the company that is changing how the world works together, announced today the introduction of vetted freelance tax professionals for businesses navigating the complexities and headaches of tax season.
  • The verified, hand-picked, and US-based freelance tax experts featured here , include licensed CPA’s, enrolled agents, financial consultants, and tax attorneys with years of experience helping businesses save and comply with federal, state, and foreign tax ordinances.
  • “Access to these vetted tax professionals will be yet another way that Fiverr helps ease complex processes for businesses.
  • Businesses can now leverage Fiverr’s freelance tax consultants alongside other industry services to get the experienced insights they need to meet their specific needs and goals.

ACTG CROI Presentation Demonstrates Superiority of HepB-CpG Vaccine Over Conventional Hepatitis B Vaccine Among People Living With HIV Who Have Not Previously Responded to Vaccination

Retrieved on: 
Wednesday, March 6, 2024
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These data demonstrated that the HepB-CpG vaccine achieved up to 99 percent protection among people living with HIV who had previously not responded to conventional hepatitis B vaccines, a noteworthy increase compared to the protection achieved by conventional vaccines.

Key Points: 
  • These data demonstrated that the HepB-CpG vaccine achieved up to 99 percent protection among people living with HIV who had previously not responded to conventional hepatitis B vaccines, a noteworthy increase compared to the protection achieved by conventional vaccines.
  • People living with HIV, especially those with lower CD4 counts, often do not develop protective antibodies after receiving conventional hepatitis B vaccines.
  • The HepB-CpG (HEPLISAV-B®) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who have not responded to conventional hepatitis B vaccines.
  • “Hepatitis B remains a significant issue for people living with HIV, as having both viruses increases the likelihood of liver complications,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024
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Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients

Retrieved on: 
Monday, March 4, 2024
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This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.

Key Points: 
  • This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.
  • Currently, DEFINITY is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.1-3
    “The expanded indication for DEFINITY is a testament to the rigorous research and development efforts undertaken by Lantheus to address unmet medical needs of pediatric patients,” said Jean-Claude Provost, MD, Chief Medical Officer.
  • “We are proud that this approval will extend the benefits of DEFINITY to healthcare professionals who work with these young individuals.”
    Clinical studies have substantiated the efficacy and safety of DEFINITY in pediatric patients.
  • The Kutty and Fine studies each reported successful left ventricular opacification in all participants.

STATE OF CELIAC DISEASE IN CANADA - UNDERDIAGNOSED, UNAFFORDABLE AND UNSAFE FOOD: SURVEY

Retrieved on: 
Wednesday, February 28, 2024
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Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.

Key Points: 
  • Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.
  • Celiac Canada surveyed 7,500 Canadians with celiac disease on topics like what symptoms they experience, how long they went before being diagnosed, and how they manage living with the disease (eating challenges in social settings, the availability and cost of gluten-free food, and the psycho-social challenges of managing celiac disease).
  • Have all provinces add blood tests for celiac disease to the standard requisition used by family doctors.
  • Help healthcare professionals better recognize the increasing neurological and mental health signs of celiac disease (neuropathy, migraines, depression, anxiety) and not just the traditional disease symptoms (like bloating, weight loss, diarrhea).

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation

Retrieved on: 
Friday, February 23, 2024
Regeneron Pharmaceuticals, Headache, Diarrhea, FDA, Food, Smoker, Back pain, Chronic obstructive pulmonary disease, Common, Safety, COVID-19, Patient, Priority, Disease, Diagnosis, Priority review, COPD, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are under review in China and Europe.

Key Points: 
  • The target action date for the FDA decision is June 27, 2024.
  • Regulatory submissions are under review in China and Europe.
  • In both trials, Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation

Retrieved on: 
Friday, February 23, 2024
Eosinophil, Headache, Diarrhea, FDA, Food, Back pain, Chronic obstructive pulmonary disease, Common, European, Safety, COVID-19, Patient, Priority, Diagnosis, Smoker, COPD, Priority review

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • The target action date for the FDA decision is June 27, 2024.
  • In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Ad tiering pays off as 36% of subscribers level up to avoid ads

Retrieved on: 
Tuesday, February 20, 2024
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But it’s a dangerous game for subscription providers, with 31% of subscribers saying they’ve canceled at least one service because ads were introduced.

Key Points: 
  • But it’s a dangerous game for subscription providers, with 31% of subscribers saying they’ve canceled at least one service because ads were introduced.
  • Strong objections also remain towards ‘premium ad tiers’, with 78% saying that paid-for subscriptions should never display ads.
  • While 35% of TV and video streamers have paid for an upgrade to avoid watching ads, this figure rises to 48% among music subscribers.
  • While many people predicted that ad tiering would be firmly rejected, in reality subscribers are welcoming the flexibility it provides.

Herbal medicinal product: Silybi mariani fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024
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Herbal medicinal product: Silybi mariani fructusArray, F: Assessment finalised

Key Points: 


Herbal medicinal product: Silybi mariani fructusArray, F: Assessment finalised