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July 22, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook PsO is an immune-mediated disease characterised by rapid skin cell proliferation leading to inflamed plaques that can cause discomfort or pain. Credit: design_cam/Shutterstock.com.
Vertex was also developing a version of the therapy called VX-264 in which the cells were encapsulated in a protective device designed to protect them from rejection by the immune system, but that failed to hit the mark in early clinical testing and has been dropped.
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?
Manasi Vaidya June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook BIO President John Crowley [L] speaking to US FDA Commissioner Dr Marty Makary [R] at the BIO International Convention in Boston. Can pharma tariffs “Make America Manufacture Again”? Data Insights The gold standard of business intelligence.
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.
Regeneron has won US Food and Drug Administration (FDA) approval for Lynozyfic (linvoseltamab-gcpt), marking the entry of another BCMAxCD3 bispecific drug in the multiple myeloma (MM) treatment space. Credit: lev radin via Shutterstock.
The biotech used these funds to establish a pipeline that includes three metabolic disease programmes, with further assets across immune disorders and endocrine diseases. Can pharma tariffs “Make America Manufacture Again”? Apple Tree Partners founded the Deep Apple in 2022, investing $52m in series A funding.
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.
The US Food and Drug Administration (FDA) has placed a clinical hold on several of Gilead’s trials evaluating two HIV treatment candidates, though the rest of the drugmaker’s diverse pipeline remains unaffected. CD4+T-cells and lymphocytes are both crucial elements of the immune system.
GSK has applied to the US Food and Drug Administration (FDA) to extend use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under the age of 50 who are at increased risk of the disease. If the latest regulatory submission is approved by the FDA, the vaccine will have indications in those aged 18 years and above.
MSD has received US Food and Drug Administration (FDA) approval for its anti-programmed death receptor-1 (PD-1) therapy, Keytruda (pembrolizumab), for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC). Keytruda is designed to enhance the immune system’s ability to detect and combat tumour cells.
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?
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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
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. Find out more Sign up for our daily news round-up!
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. It has also been approved in expanded indications in GPP in certain territories.
The US Food and Drug Administration (FDA) has expanded approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot will be recommended for broader use in the national immunisation schedule. Can pharma tariffs “Make America Manufacture Again”?
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. Can pharma tariffs “Make America Manufacture Again”?
The drug is being evaluated as both a monotherapy and in combination with Merck & Co’s Keytruda (pembrolizumab) for cancers such as melanoma, after demonstrating tumour regression, enhanced T-cell infiltration, and durable immune memory in preclinical studies. This field is required.
RFK Jr has flip-flopped between endorsing and shunning the MMR vaccine , a shot that is proven to provide strong immunity against the disease. Can pharma tariffs “Make America Manufacture Again”? When science is politicised, people suffer.”
Data from the REZOLVE-AD study of rezpegaldesleukin in moderate-to-severe AD showed significant improvements over placebo across a series of efficacy measures in the trial, and it now intends to discuss a phase 3 programme with the FDA to support approval as a new first-in-class treatment for the skin condition.
A low incidence of immune effector cell-associated neurotoxicity syndrome was reported during the step-up dosing phase and the target dose phase. Can pharma tariffs “Make America Manufacture Again”? Two patients experienced dose-limiting toxicities and continued to receive the targeted dose.
KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.
It is delivered directly to patients using a proprietary lipid nanoparticle formulation (LNP) that can be aimed at specific cells using a targeting component, such as an antibody, carrying an mRNA that encodes an anti-CD19 CAR that can reprogramme CD8-expressing cytotoxic T-cells and "reset" the immune system.
The CDCs newly constituted Advisory Committee on Immunization Practices (ACIP) has voted to recommend the removal of vaccine preservative, thimerosal, that has become a focal point for activists trying to link vaccines to autism.
Birthplace: Belén was born in Almansa (Spain) Additional Information: Merck became a significant international participant in immunology, oncology, and immune oncology under her leadership of the Healthcare business. and Banco Bilbao Vizcaya Argentaria S.A " LinkedIn Total experience: 29 yrs. LinkedIn Total experience: 31 yrs.
The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.
Amongst the new members on the CDC’s Advisory Committee for Immunization Practices (ACIP) are well-known vaccine sceptics and individuals who were critical of both the Covid-19 vaccines and related countermeasures such as lockdowns. Can pharma tariffs “Make America Manufacture Again”?
Earlier this year, the FDA said it would restrict booster doses in older adults and those at risk of severe illness. RFK Jr has also blocked CDC communications, cancelled vaccine panel meetings at the FDA and CDC without explanation, and initiated investigations into links between vaccines and autism.
George Merck on the cover of Time magazine. The FDA’s Frances O Kelsey: by blocking approval of Thalidomide in the US, Kelsey prevented thousands of children being born with life-changing deformities. Photo: FDA. Thalidomide and the development of drug safety regulation and monitoring.
EYs latest Biotech Beyond Borders report acknowledges the seismic changes in the US in the last few months, including cuts to NIH funding , staff reductions at the FDA which could affect its ability to review and approve new products, the threat of tariffs on medicines, and new drug pricing proposals such as Trumps most favoured nation policy.
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