Infectious Diseases

Pfizer Announces Positive Top-Line Results from Phase 3 Study of ABRYSVO® in Adults Aged 18 to 59 at Increased Risk for RSV Disease

Retrieved on: 
Tuesday, April 9, 2024

Adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD1,2.

Key Points: 
  • Adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD1,2.
  • However, no RSV vaccines have been approved for use in adults 18 to 59 years of age.
  • The MONeT study was initiated to address this significant unmet need by investigating the immunogenicity and safety of ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease, such as those with asthma, diabetes, and chronic obstructive pulmonary disease.
  • “These encouraging results provide evidence that ABRYSVO can help protect adults with increased risk against RSV-associated illness,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer.

Real Time Medical Systems Brings Post-acute Care Focus to NAACOS Spring 2024 Conference

Retrieved on: 
Tuesday, April 9, 2024

Real Time Medical Systems (Real Time), the industry leading, KLAS Rated, and HITRUST Certified post-acute analytics solution, announced today its presence at the National Association of ACOs (NAACOS) Spring 2024 Conference on April 10-12, 2024.

Key Points: 
  • Real Time Medical Systems (Real Time), the industry leading, KLAS Rated, and HITRUST Certified post-acute analytics solution, announced today its presence at the National Association of ACOs (NAACOS) Spring 2024 Conference on April 10-12, 2024.
  • Real Time joins CMS officials, ACO leaders, and policy insiders in Baltimore, MD, to demonstrate how providers can reduce hospital admissions/readmissions, minimize length of stay, and improve care coordination in the post-acute setting through Real Time’s interventional analytics platform.
  • The session takes place on Thursday, April 11, 2024, at 7:30am – 8:15am.
  • “I thoroughly enjoy speaking to the NAACOS audience,” states Phyllis Wojtusik, RN.

Nvelop Therapeutics Launches with Dual Platforms for In Vivo Delivery of the Next Generation of Genetic Medicines

Retrieved on: 
Tuesday, April 9, 2024

Nvelop Therapeutics , a biotechnology company engineering programmable, non-viral vehicles for the in vivo delivery of therapeutic cargo, today formally announced its launch to develop the next generation of genetic medicines for a wide range of diseases.

Key Points: 
  • Nvelop Therapeutics , a biotechnology company engineering programmable, non-viral vehicles for the in vivo delivery of therapeutic cargo, today formally announced its launch to develop the next generation of genetic medicines for a wide range of diseases.
  • The company’s approach has the potential to enable highly efficient and cell-specific delivery of a broad set of therapeutic cargoes.
  • “The field of genetic medicine is significantly limited by the challenge of efficiently delivering therapeutic cargoes to many types of target cells in vivo,” said Jeff Walsh, Nvelop’s Chief Executive Officer.
  • In vivo data for the second platform is expected to be disclosed at one or more scientific meetings this year.

Media Advisory: DoseMe Bioinformatician and Chief Science and Strategy Officer Co-Author Abstract Big Data Bayesian Truths to Be Covered in Oral Presentation at the 24th ECCMID Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024

ECCMID is the annual meeting of ESCMID, the European Society of Clinical Microbiology and Infectious Diseases, a registered non-profit organization in Basel, Switzerland.

Key Points: 
  • ECCMID is the annual meeting of ESCMID, the European Society of Clinical Microbiology and Infectious Diseases, a registered non-profit organization in Basel, Switzerland.
  • Abstract co-authored Dr. Sharmeen Roy, PharmD, BCPS , Chief Strategy and Science Officer and Paul Sabourenkov , Lead Bioinformatician at DoseMe.
  • What: Abstract 05305, Big Data Bayesian Truths: no vancomycin trough concentration target is sufficiently precise for safety or efficacy.
  • Details: Title: Big data Bayesian truths: no vancomycin trough concentration target is sufficiently precise for safety or efficacy.

VBI Vaccines Announces $2 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Tuesday, April 9, 2024

In a concurrent private placement, VBI will issue unregistered warrants to purchase up to 2,272,728 common shares.

Key Points: 
  • In a concurrent private placement, VBI will issue unregistered warrants to purchase up to 2,272,728 common shares.
  • The gross proceeds to VBI from this offering are expected to be approximately $2 million, before deducting the placement agent’s fees and other offering expenses.
  • The offering of the securities in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement.
  • A prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC.

Pandemic Accord Must Work for All, says AHF

Retrieved on: 
Monday, April 8, 2024

“The COVID-19 pandemic exposed how woefully unprepared we were in responding to deadly outbreaks – and sadly, four years later, we are still not prepared for the next big health crisis,” said AHF President Michael Weinstein.

Key Points: 
  • “The COVID-19 pandemic exposed how woefully unprepared we were in responding to deadly outbreaks – and sadly, four years later, we are still not prepared for the next big health crisis,” said AHF President Michael Weinstein.
  • “World leaders must get the Pandemic Accord back on track and negotiate it in good faith for the entire world—not just what’s best for their political and financial interests.
  • The new pandemic agreement must be based on transparency, accountability, and cooperation.
  • If World Health Assembly Member States fail to heed lessons from the past pandemic, the world will be right back where we started with COVID-19.

Unitaid Awards Medincell up to $6 million Extension Grant to Fight Malaria

Retrieved on: 
Monday, April 8, 2024

Global health agency Unitaid has awarded Medincell (Paris:MEDCL) an extension grant of up to US$ 6 million over three years to fund the clinical phase 1 activities of long-acting injectable mdc-STM.

Key Points: 
  • Global health agency Unitaid has awarded Medincell (Paris:MEDCL) an extension grant of up to US$ 6 million over three years to fund the clinical phase 1 activities of long-acting injectable mdc-STM.
  • If proven safe, effective, and acceptable, mdc-STM could have a significant impact on transmission of malaria among vulnerable populations in high-transmission areas.
  • mdc-STM is an investigational three-month active injectable formulation of ivermectin using Medincell’s BEPO® technology to fight malaria transmission.
  • Medincell is committed to the fight against the major global health threats, such as malaria that remains endemic in 85 countries representing 50% of the world's population.

ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV

Retrieved on: 
Monday, April 8, 2024

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1
    In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people.
  • Lynn Baxter, Head of North America at ViiV Healthcare, said: "This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment.
  • As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”
    The approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults).1 Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to ≤500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48.1 The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.1 Exposures for components of Dovato were higher but were not clinically significant.1

Infectious Disease Diagnostics Research Revolution 2024: New Report Analyzes OTC and DTC Trends and Strategies Through 2027 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 5, 2024

5.2.2 Infectious Disease is Declining But..

Key Points: 

5.2.2 Infectious Disease is Declining But..
5.3.7 Sample Collection - Who Knew?
6.3 Co-Diagnostics Awarded $2.3M for TB, HPV Tests
6.32 Biohacking trend supports self-testing.
6.33 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market

Agenus Announces Reverse Stock Split of Common Stock

Retrieved on: 
Friday, April 5, 2024

The reverse stock split is intended to give Agenus greater flexibility in its future financing needs and to increase the per share trading price of Agenus’ common stock to satisfy the minimum price requirement for continued listing on the Nasdaq Capital Markets and to qualify for inclusion in the Russell Indices.

Key Points: 
  • The reverse stock split is intended to give Agenus greater flexibility in its future financing needs and to increase the per share trading price of Agenus’ common stock to satisfy the minimum price requirement for continued listing on the Nasdaq Capital Markets and to qualify for inclusion in the Russell Indices.
  • The reverse stock split affects all issued and outstanding shares of Agenus’ common stock.
  • The par value of the Agenus’ common stock will remain unchanged at $0.01 per share after the reverse stock split.
  • The reverse stock split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in Agenus’ equity, except to the extent that the reverse stock split results in some stockholders receiving cash in lieu of any fractional shares as described below.