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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. Kennedy Jr.
You just want to slash it, rip it out or attack it like an enemy target,” said Benjamin Zeskind, co-founder, CEO and president of Immuneering Corporation. To overcome that hurdle, Immuneering is testing an approach that slows cancer down rather than rushing to destroy it.
The product is offered in a 4×14 patient-compliant pack with day/night markers and matte foil packaging. per cent dissolution rate, anti-counterfeit Holosec packaging, and competitive pricing at 39.9 per cent dissolution rate, anti-counterfeit Holosec packaging, and competitive pricing at 39.9 The company notes its 98.23
pharma is facing potential headwinds as the FDA’s attitude toward immunizations shifts under new leadership. The FDA nod comes as GSK pushes ahead with a goal to launch five new products this year. A long-time leader in vaccines, the U.K.
The technology utilises outer membrane vesicles (OMVs) to deliver antigens, often eliminating the need for adjuvants while triggering the immune response. Discovered and developed by GSK’s global health team scientists, the GMMA technology is a low-cost platform ideal for creating vaccines in resource-limited settings.
Similarly, while some nanoscale delivery systems can exhibit prolonged lifetimes in the bloodstream, others have short circulation times or can be viewed as foreign materials by the immune system and rapidly cleared. These uncertainties and complexity of nanoscale drug delivery systems often lead to regulatory challenges.
billion buyout of Blueprint Medicines doubled down on the French pharma giant’s focus on drugs that impact the immune system. “Neurology has certainly emerged over the last couple of years as a therapeutic area where theres been a bit of a resurgence, if I can call it that, in terms of investment,” Singhania said.
The European Commission (EC) has approved argenx’s Vyvgart (efgartigimod alfa) 1000mg as a single agent for subcutaneous injection to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP), an immune-mediated neuromuscular disorder of the peripheral nervous system.
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. 2 A prominent aspect of this issue that manufacturers have tried to tackle is medication recognition when transferring pills to containers and packaging. 1-3 Detect-A-Dose Lid Label Covers.
This integration will reinforce Juvenescence’s pipeline in cardio-metabolism, cognition, immunity and cellular repair sectors. Incorporating Ro5’s AI platform into Juvenescence is expected to accelerate the development of AI-enabled treatments. Give your business an edge with our leading industry insights.
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.
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. USAID is a crucial lifeline around the globe, providing technical assistance, infrastructure support, and emergency relief.
June 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook HBM7020 activates immune system T cells to target and destroy B cells and plasma cells involved in many autoimmune diseases. Credit: luchschenF /Shutterstock. Give your business an edge with our leading industry insights.
Currently, we are actively working on co-packaging collaborations with pharma companies to drive adoption across various medical sectors, including paediatrics, infertility treatments, and broader healthcare applications. Have needle-free injection systems made inroads into the existing injection market? What are the projections?
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.
The dual-mechanism biologic targets the overactive immune system, and leverages a combination of a low dose IL-2 and CTLA4-lg fusion protein to reduce inflammation through Treg cell enhancement. According to Swaminathan, targeting Tregs, a subset of T cells, may be key to reducing disease progression of ALS.
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. Give your business an edge with our leading industry insights.
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% higher at $185.62 on 30 June, the day the announcement was made.
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 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. 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. How will RFK Jr’s American dream for vaccines play out?
The biotech used these funds to establish a pipeline that includes three metabolic disease programmes, with further assets across immune disorders and endocrine diseases. Apple Tree Partners founded the Deep Apple in 2022, investing $52m in series A funding. Give your business an edge with our leading industry insights.
A single dose of the vaccine in adults aged 18-49 at increased risk of RSV-LRTD elicited robust immune responses that were non-inferior to those observed in adults aged 60 and above. That is instead recommended by the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP).
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.
fired 17 sitting members of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention (CDC), concerns rose about the stance of federal agencies on vaccines. Give your business an edge with our leading industry insights.
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. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. How will RFK Jr’s American dream for vaccines play out? Sino revealed the acquisition agreement after trading hours on 15 July. The share price in the company had climbed 3.6% by market close. 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.”
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?
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.
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. How will RFK Jr’s American dream for vaccines play out?
This approval was supported by results from Moderna’s Phase III study (NCT06067230), which demonstrated the vaccine’s immune response worked just as well in this age group compared to the existing approved age group of 60 years and older. The expanded approval now includes individuals aged 18 to 59 who are at risk of RSV.
1] This inability to detox properly can trigger or worsen autoimmune symptoms, as these chemical exposures can trigger immune dysregulation. [2] 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.
The US department of Health and Human Services (HHS) has culled the 17 Biden-appointed members on the Advisory Committee for Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) in a move observers warn is liable to further fuel the spread of vaccine-preventable illnesses. lev radin via Shutterstock.
By GlobalData Learn more about Strategic Intelligence By covering a wide range of targets on malignant B cells, the therapy aims to enhance safety and efficacy while minimising the potential of tumour cells for developing immune-resistance mechanisms such as antigen escape. Give your business an edge with our leading industry insights.
In a controversial move on 9 June 2025, US Secretary of Health and Human Services Robert F Kennedy Jr dismissed all 17 members of the Centers for Disease Control and Prevention (CDC) Advisory Committee for Immunization Practices (ACIP) that advises the federal government on vaccine safety.
RFK Jr has flip-flopped between endorsing and shunning the MMR vaccine , a shot that is proven to provide strong immunity against the disease. Give your business an edge with our leading industry insights.
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.
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. These insights give us a critical edge in responding to both emerging infectious threats and optimizing existing immunization strategies." Kennedy Jr.
Packages valued at less than $800 that enter the U.S. A recommendation from the Advisory Committee on Immunization Practices must be approved by the director of the CDC or the health secretary to come into force. The findings are likely an undercount, because unregistered vendors may not disclose that their parcels contain medicines.
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