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June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook GSK’s vaccine leverages GMMA technology. GSK has licensed altSonflex1-2-3, its Shigella vaccine candidate, to Bharat Biotech for continued development and distribution in low and middle-income nations. Credit: viewimage/Shutterstock.
In a vote of 5 to 1 on Thursday, members of the Advisory Committee on Immunization Practices (ACIP) voted to recommend against influenza vaccine containing the preservative thimerosal. The recommendations include all US adults as well as recommending pregnant women also receive a thimerosal-free vaccine for influenza.
A long-time leader in vaccines, the U.K. pharma is facing potential headwinds as the FDA’s attitude toward immunizations shifts under new leadership. Blujepa is also the first new treatment cleared for the indication in about three decades, according to GSK.
What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.
Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork.
Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.
It's cognitive behavioral therapy packaged as a digital experience. I've even seen VR experiences, so it can be packaged in any type of digital experience. Areo Nazari, PharmD: PDTs are digital or software-based treatments that are approved by the FDA to treat disease.
The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections. Implications of RFK Jr.’s Implications of RFK Jr.’s
In June 2025, the White House submitted a formal rescissions package to Congress that proposed eliminating billions in foreign aid funding—including over $8 billion allocated to USAID. Most notably, they threaten research intended to develop the first HIV vaccine.
Package insert. FDA approves tablet formulation of BeOne's BRUKINSA for all approved indications. News Release. Released June 11, 2025. Accessed June 11, 2025. BeiGene USA, Inc.; Accessed June 11, 2025.
In a new CDC report, investigators found that there was no connection between thimerosal in vaccines and autism or other neurodevelopmental conditions. The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines.
How will RFK Jr’s American dream for vaccines play out? Go deeper with GlobalData Reports LOA and PTSR Model - Briquilimab in Severe Combined Immune Deficien. Reports LOA and PTSR Model - Immune Globulin (Human) in Chronic Lymphocytic. Reports LOA and PTSR Model - Immune Globulin (Human) in Chronic Lymphocytic.
By GlobalData Learn more about Strategic Intelligence FDA’s strategy on trial designs, vaccines and manufacturing Earlier this month, when the Department of Health and Human Sciences Secretary Robert Kennedy Jr. Give your business an edge with our leading industry insights.
How will RFK Jr’s American dream for vaccines play out? The US Food and Drug Administration (FDA) has approved Takeda’s new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. Credit: HenadziPechan/Shutterstock.
While BioNTech is best known for co-developing the first approved mRNA vaccine with Pfizer, the company continues to invest heavily in mRNA research targeting various solid tumors and infectious diseases. Its technology platforms are built to enhance immunogenicity while maintaining low-dose efficiency—a key factor for scalability and safety.
How will RFK Jr’s American dream for vaccines play out? A preliminary look at the data from Capstan has revealed strong B-cell depletion – the aim of the treatment is to achieve an ‘immune reset’ by repopulation of healthy B cells. Investors shared positive sentiment in the acquisition, with shares in NYSE-listed AbbVie closing 1.7%
How will RFK Jr’s American dream for vaccines play out? It comes with one for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-foetal toxicity.
Find out more This treatment involves obtaining immune cells from patients, modifying them in a laboratory setting then reintroducing them into patients’ bodies to destroy cancerous cells. Data Insights The gold standard of business intelligence. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines. Moreover, protein-based drugs are also well tolerated inside the body, thereby reducing the chances of causing any immune response in the body.
How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. MAXSHOT.PL via Shutterstock.
CD4+T-cells and lymphocytes are both crucial elements of the immune system. The FDA placed a hold on the trials due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the GS-1720 and GS-4182 combination.
How will RFK Jr’s American dream for vaccines play out? LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. Sino revealed the acquisition agreement after trading hours on 15 July. The share price in the company had climbed 3.6% by market close.
How will RFK Jr’s American dream for vaccines play out? Its design minimises interaction with Fc-gamma (Fcγ) receptors on macrophages, enhancing the ability of the body’s immune cells to recognise and combat tumours. Give your business an edge with our leading industry insights.
Keytruda is designed to enhance the immune system’s ability to detect and combat tumour cells. Based on these trial results, Keytruda as part of this regimen shows potential to change long-standing standards of care for treating certain patients with locally advanced HNSCC.” Give your business an edge with our leading industry insights.
How will RFK Jr’s American dream for vaccines play out? Go deeper with GlobalData Reports LOA and PTSR Model - Briquilimab in Severe Combined Immune Deficien. Nominate Now Share Copy Link Share on X Share on Linkedin Share on Facebook Go deeper with GlobalData Reports LOA and PTSR Model - Briquilimab in Severe Combined Immune Deficien.
How will RFK Jr’s American dream for vaccines play out? LEO’s new asset is a monoclonal antibody that blocks the activation of the interleukin-36 (IL-36) receptor – a key signalling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases.
Robert Barrie June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. Until now, the vaccine was licensed for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
Mark Lansdell Director of custom intelligence, Evaluate The drug, already approved in China, is a bispecific antibody that targets both PD-1 and vascular endothelial growth factor (VEGF), a protein that promotes blood vessel growth and helps shield tumors from the immune system.
GlobalData Healthcare June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Changes to ACIP could result in regulatory uncertainty for vaccine developers and manufacturers. Malone, an early mRNA pioneer, has made unfounded claims regarding the dangers of mRNA vaccines, which have sparked significant public backlash.
Robert Barrie and Ross Law June 10, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The removal ACIP members marks the most significant upheaval to the current vaccine landscape under Trump’s administration. lev radin via Shutterstock. lev radin via Shutterstock. Data Insights The gold standard of business intelligence.
Scientific experts are concerned about what role vaccines will play in US public health strategy under the Trump administration. Robert Barrie June 25, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook RFK Jr has embarked on a mission to reset vaccine regulation and evidence generation in the US.
A low incidence of immune effector cell-associated neurotoxicity syndrome was reported during the step-up dosing phase and the target dose phase. Two patients experienced dose-limiting toxicities and continued to receive the targeted dose. Give your business an edge with our leading industry insights.
Infections are still far below historic pre-vaccine levels, but three people have died from the virus this year. In the decades before immunization was possible, 3 million to 4 million Americans were infected with measles each year. has been uneven in his support for immunizations. but HHS Secretary Robert F. Kennedy Jr.
Packages valued at less than $800 that enter the U.S. Centers for Disease Control and Prevention on vaccines voted to recommend the use of a new monoclonal antibody against RSV in babies, Merck’s Enflonsia , STAT tells us. under the de minimis rule are not included in the data. A committee that advises the U.S. Whether U.S.
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.
s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond. ACIP plays a foundational role in shaping immunization policy in the US.
The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).
US Health Secretary Robert F Kennedy (RFK) Jr has appointed eight new members to the vaccine advisory panel at the Centers for Disease Control and Prevention (CDC), just days after firing the panel’s previous members in full. Credit: LightRocket via Getty Images. Who’s on the panel? Don’t let policy changes catch you off guard.
In the pipeline are treatments that attempt to accomplish this by borrowing stealthing technologies from other fields, like gene therapy’s viral vector workhorse, AAV , or the lipid nanoparticles that coat RNA-interfering drugs and mRNA vaccines. Continue to STAT+ to read the full story…
It inhibits the body’s immune system response, decreasing the inflammation and discomfort associated with gout. For example, because it reduces immune resistance, it could make you more susceptible to infection. It might work quickly, too. Some people may feel some relief within an hour.
Practical examples of this include healthcare professionals using VR to learn various medical procedures or for the technology to be used to teach broader society about public health issues, such as the importance of vaccination. When both ‘treatments’ were combined, the vaccination intention increased even further. The more you know.
Their responsibilities have expanded to include complex tasks such as medication therapy management, immunization administration, and medication reconciliation, she says. What’s more, pharmacy technicians are also crucial to the execution of immunizations and medication therapy management, he adds.
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