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Today, we talk about the readout of Compass Pathways’ psilocybin trial for major depressive disorder, see more vaccine concern and turnover at the FDA, and report from the American Diabetes Association.
This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs.
According to Trump, patients could see cost reductions of 30% to 80%, but experts question the feasibility and practicality of implementing such a policy within the complex United States drugpricing and supply system.
and outperformed maternal vaccines in public health programs. Vaccines to treat RSV normally start in early fall, and having these additional shipments in advance is expected to give healthcare providers (HCPs) an additional assurance and confidence. Sanofi and AstraZeneca have tripled production capacity to meet growing demand.
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.
Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription DrugPricing to American Patients,” with the objective of lowering drugprices, namely on branded drug products, for American consumers.
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.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? July 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The companies aim to gain insights that could contribute information towards designing more vaccines.
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.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? July 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The acquisition includes vaccine candidates for respiratory syncytial virus and human metapneumovirus.
Sarepta is working on a new regimen of immune-suppressing drugs to manage the safety risks, and plans to soon share its findings with the FDA. The company’s share price is lower by more than 80% this year amid concerns about Elevidys’ future and the chance new FDA leadership might restrict its use. TechTarget, Inc.s
How will RFK Jr’s American dream for vaccines play out? By GlobalData Learn more about Strategic Intelligence Boxed warnings are common for T-cell directing drugs, and Lynozyfic is no different.
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? Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. MAXSHOT.PL via Shutterstock. A decision by the FDA is expected in H1 2026.
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 share price in the company had climbed 3.6% LaNova’s drug development 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.
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.
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.
billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immunedrug developer since April 2023. You can unsubscribe at anytime. Track the deals that are happening here. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1
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 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. Go deeper with GlobalData Reports United States of America (USA) DrugPricing and Reimbursement Lands.
After the second death, Sarepta began working on a new regimen of immune-suppressing drugs it hopes will make treatment safer. You can unsubscribe at anytime. Treating muscular dystrophies can require large doses, which is thought to raise the chances of dangerous liver side effects. Registered in England and Wales. TechTarget, Inc.s
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals DrugPricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 headquarters in Bridgewater, New Jersey.
Dispatch aims to deliver to cancer cells a sequence for a unique type of protein flag, known as an antigen, that it says can draw in specially engineered immune cells it plans to administer afterwards. Drugs like Merck & Co.’s s Keytruda, known as checkpoint inhibitors, can spur the immune system to fight cancer.
The trade group, however, insisted the FDA “acted to benefit special interests, raise drugprices and deprive much of the public of access to a needed medicine.” A group of doctors and medical practices claimed they overpaid for the vaccine, which was the only mumps shot in the U.S. ” A U.S.
These therapies have incredible potential to fight cancer and other diseases using the patient’s own immune system. Some will simply raise drugprices to get more money out of new drugs while they can; others are planning to phase in new indications in order to “reset the clock” as many times as they can.
’s handpicked members of a vaccine advisory committee, see Sen. Bill Cassidy quietly explore a “most-favored nation” pricing policy for prescription drugs, and more. installs vaccine critics on CDC panel Health secretary Robert F. Today, we look at health secretary RFK Jr.’s RFK Jr.
Regulatory pressures, lengthy drug development times, and the fact that drugprices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion. Moreover, the range of companies benefiting from investor interest has not been limited to those developing a vaccine.
Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drugprice transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drugprice transparency reporting.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals DrugPricing Gene Therapy An article from Vaccines RFK Jr. In a statement, HHS said Kennedy’s action fulfills “a commitment to restore trust with Americans by removing risk while sustaining access to vaccines.”
How will RFK Jr’s American dream for vaccines play out? Robert Barrie July 8, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The lawsuit marks the first legal challenge posited to RFK Jr and the HHS since his remodelling of vaccine regulation in the US.
Cidara will provide detailed results at a future medical meeting and intends to meet with the Food and Drug Administration to discuss the design of a Phase 3 trial. Study success could open the door to an alternative to seasonal influenza vaccines, which some Wall Street analysts view as a multibillion-dollar sales opportunity.
See you soon… The Trump administration is pushing pharmaceutical companies to begin negotiations to bring their drugprices in line with what other countries pay — usually far less than Americans , STAT tells us. Two new vaccine advisers tapped by U.S. Health and Human Services Secretary Robert F.
This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. What Will 2025 Mean for Medicare DrugPrice Setting Under the IRA?
have on vaccines in the U.S.? ’s vaccine views could shape policy President-elect Trump’s decision to entrust noted vaccine skeptic Robert F. One of particular import: What impact will his relationship with Robert F. Kennedy Jr. We have a look at that question today, discuss another U.S. How RFK Jr.’s
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