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Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today.
Today, we see insulin-producing cells survive in a human body without triggering an immune rejection, and have some big news from CMS. Hope those of you who were in San Francisco for J.P. Morgan are resting, recovering, and not coping with any quad-emic strains. Read the rest…
The need-to-know this morning Nektar Therapeutics said its embattled immunedrug rezpeg significantly improved skin clearance rates in patients with atopic dermatitis, achieving the goals of a Phase 2 study. The stock more than doubled in price in early trading.
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.
Simone Steiner, CTO, Transgene Permission granted by Trangene “In drugdevelopment the risks are high, and for anyone who has been in the industry for a period of time, they are likely to have experienced such failures,” Steiner said.
For example, The patient in intensive care who develops a rash while receiving multiple medications The ambulatory with complex chronic diseases who develops a new and unexplained symptom while taking many medications. The main questions that arise in such situations include: Is the adverse event related to a drug?
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drugdevelopment, and offers potential market exclusivity for up to 7 years.
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.
SHOW MORE With robust pipelines, cell therapy remains the major driver for drugdevelopment. The field is expanding into autoimmune diseases, with nononcology trials representing 51% of the pipeline by late 2024.
Bain will acquire a centuries-old drugmaking division currently developing medicines for neurological and immune disorders, among other kinds of conditions, allowing Mitsubishi to focus on its core chemical business. billion, in one of the private equity firm’s largest life science deals.
Though these companies operate on longer timelines and more complex supply chains, they arent immune. As price cuts affect the blockbuster drugs they help manufacture, their contract revenue is indirectly exposed. Even biologics manufacturers are being affected. How should Asian pharma brands respond to this trend? Absolutely.
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.
Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. Love Employee via Getty Images Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review strategic alternatives.
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.
Few diseases have suffered more drugdevelopment disappointment than amyotrophic lateral sclerosis. Earlier this year, an experimental drug from Denali Therapeutics, and a candidate from Calico Life Sciences and AbbVie, failed in the clinic. Please let us know if you have feedback.
These medicines are made from a patient’s own immune cells, extracted from the body and engineered in a lab to hunt down specific proteins found on the surface of malignant clones. But their administration also comes with notable risks, including a hyperactive immune response known as CRS and neurological toxicity dubbed ICANS.
Some companies are combining mRNA vaccines with programmed cell death protein 1 (PD-1) inhibitors to activate the immune system and elicit tumour-specific T-cell responses. The LNPs provide targeted delivery of the mRNA directly to tumours, resulting in strong immune activation, tumour elimination, and durable immunological responses.
But many other modes of immunotherapy for cancer were approved first — checkpoint blockade drugs like Keytruda and engineered immune cell therapies like Yescarta. Cancer vaccines may also be able to help train the immune system to recognize and kill cancers related to viruses like HPV.
However, the company went on to say that as many as 60% of patients treated with CAR-T cells experience “high-grade toxicities,” such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. million (approximately US$1.99
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?
health agencies have also added restrictions to COVID-19 shots and are considering new rules that could increase the time and cost of vaccine drugdevelopment. But the reality right now is that immunization rates are stalling and millions of infants are missing out on critical vaccinations.
For example, characterization testing of a cell-based product may include extended assessment of cell surface phenotypic markers, such as those associated with immune-cell activation, differentiation, and exhaustion.
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).
Reports Use of Artificial Intelligence in Pharmaceutical DrugDevelopment a. 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. Find out more Sign up for our daily news round-up!
LaNova’s drugdevelopment focuses on tumour immunity and the tumour microenvironment. The company has particular emphasis on antibody-drug conjugates (ADCs) and has built several platforms within this modality. A timeline of 30 business days has been set by the companies to finalise the deal. by market close.
The drug will be marketed under the brand name Ekterly. Cogent Biosciences reported results from a Phase 3 study of bezuclastinib in indolent systemic mastocytosis, the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.
billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immunedrugdeveloper since April 2023. Track the deals that are happening here. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1
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. It has also been approved in expanded indications in GPP in certain territories.
The charity, the Telethon Foundation, took ownership from a small biotech of a drug that has been approved in Europe to treat an ultra-rare immune disorder called ADA-SCID. Recently, though, it added an unusual new role — as a gene therapy company of sorts. Continue to STAT+ to read the full story…
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.
As a bispecific T-cell engager (BiTE) therapy, Blincyto (blinatumomab) provides a new treatment approach, helping the immune system to recognise and eliminate residual cancer cells following initial treatment. The field of myeloma is probably one of the biggest examples of successful drugdevelopment in modern times, Kowalski explained.
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.
The 7th Inflammasome Therapeutics Summit is your go-to forum for drugdevelopers, translational scientists, and immunology innovators striving to push inflammasome-targeted therapies from concept to clinic. If you are serious about leading the charge in inflammasome drugdevelopment, this is where the future takes shape.
The Phase 1 trial, which enrolled 118 healthy volunteers, tested the safety and tolerability of KT-621, a small molecule drug that targets STAT6, a signaling protein that plays a key role in driving immune activation.
The cause of death is still being investigated but Rocket said the patient experienced complications due to capillary leak syndrome, possibly tied to an immune-suppressing treatment used prior to the patient receiving the Rocket gene therapy, called RP-A501. The FDA placed the study on clinical hold.
The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals against Covid-19. The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023.
Biotech investors have been buzzing around new areas of drugdevelopment this year, such as the red-hot obesity market. billion to companies developing treatments for conditions in which the body’s own immune system goes haywire, attacking healthy cells and tissues and causing widespread damage.
Biogen is joining the industry’s fervor over immune and inflammatory disease drugdevelopment with a new acquisition. HI-Bio, which is based in San Francisco, is developing therapies for immune-mediated diseases like primary membranous nephropathy and IgA nephropathy, both of which impact kidney function.
Recognising the potential of CAR T cells to act as highly targeted therapeutics, several biotechnology companies – including Sangamo Therapeutics – have established development pipelines of CAR T regulatory cells (Tregs) that aim to tackle immune?mediated What are Tregs and how are they applicable to immune-mediated disease?
The 2nd NSCLC DrugDevelopment Summit returns for its second year to unite biopharma and academic leaders during an exciting era of personalized medicine. Improve your drugdevelopment rationale across all lines of NSCLC and address challenges when moving therapies forward. Progress sequencing and combination approaches.
A partnership between Immunai and 10x Genomics will use artificial intelligence to create a map of the immune system to help accelerate drugdevelopment.
The promise has long been an affordable, personalized cancer vaccine that could train the immune system to recognize proteins from cancer cells and, subsequently, destroy the tumor.
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