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WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine makers, focused primarily on Covid-19 shots, in the coming weeks.
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. Sign up to get our biotech newsletter in your inbox.
WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply.
A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe. The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa. Read the rest…
HHS cancels flu pandemic vaccine contract In a blow to pandemic preparedness, HHS cancelled a nearly $600 million contract with Moderna to develop, test, and license vaccines for flu strains that could trigger future pandemics, including the H5N1 bird flu virus, Helen Branswell and Matthew Herper report.
SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. 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.
Today, we talk about the uptick in physicians using ctDNA to determine if resected cancers are truly gone, we see the FDA offering new guidelines for Covid-19 vaccines, and more. Sign up to get our biotech newsletter in your inbox. Read the rest…
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. Kennedy Jr.
Also, Moderna’s RSV vaccine efficacy seems lackluster compared to competitors, and the Bernie Sanders drug pricing song-and-dance did not seem to faze pharma CEOs. Sign up to get our biotech newsletter in your inbox. Give it a listen. Read the rest…
Damian here with a rare look at a biotech in collapse, Moderna’s ambitious future in vaccines, and what looks like a massive missed opportunity. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, all. Read the rest…
We see a new startup emerge that aims to compete with Vertex Pharmaceuticals, and learn of Phase 1 results for Replicate’s srRNA rabies vaccine. Today, we discuss how Biogen’s missed the mark with Leqembi, but how it’s also not exactly a surprise. Read the rest…
BOSTON — GSK has been developingvaccines under one corporate guise or another for 140 years, ever since a rural Pennsylvania doctor started pumping smallpox shots out of a converted chicken house in 1882, but the company may be most known today for the vaccine it didn’t build.
Also, lots of updates on vaccines, and Ginkgo starts subleasing its lab space. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we bid adieu to NIH luminary Francis Collins. Read the rest…
It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccinedevelopment. Innovative new vaccines are being created more rapidly than ever before.
The Department of Health – Abu Dhabi (DoH) and Sanofi have signed a memorandum of understanding (MoU) to bolster vaccinedevelopment by leveraging local health-tech ecosystems and research infrastructure. Credit: Department of Health Abu Dhabi.
Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19. It also waived its rights to bring the lawsuit when it pledged not to sure other COVID-19 vaccine producers during the pandemic, according to Reuters.
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 vaccinedevelopers and manufacturers. Go deeper with GlobalData Reports ESG (Environmental, Social, and Governance) in Healthcare - Themati.
CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drugdevelopment, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up.
These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. The study will compare the relative efficacy of next-generation vaccines against approved vaccines to prevent symptomatic, PCR-confirmed SARS-CoV-2 infection.
Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.
Turku, Finland – March 15, 2023 – DelSiTech Ltd, a Finnish drug delivery and drugdevelopment company, today announces that it has been awarded a grant from the Bill & Melinda Gates Foundation to develop long-acting injectable formulations ensuring the slow release of human immunodeficiency virus (HIV) vaccine.
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.
Vaccines are the original immunotherapy, in the view of Ryan Sullivan, a cancer immunotherapy researcher and oncologist at Mass General Cancer Center. But many other modes of immunotherapy for cancer were approved first — checkpoint blockade drugs like Keytruda and engineered immune cell therapies like Yescarta.
In recent years, the pharmaceutical industry has exhibited a significant shift into digitalisation, with AI pushing for innovation across the entire drugdevelopment value chain, from accelerating drug discovery to optimising clinical trial design to ultimately improve patient outcomes.
A Marburg fever outbreak in Equatorial Guinea is galvanizing efforts to test drugs and vaccines for a virus that currently has none. But every day counts, warned experts who gathered virtually on Tuesday to try to chart a course for the work.
Drugdevelopment is essentially a long, expensive bet: 90% of drugs fail during clinical trials, goes one of the life science industry’s most oft-quoted statistics. But they cautioned that the pace of future successes will depend on whether the industry can streamline and rethink drugdevelopment.
For example, pharma lobbyists are pushing for a fix to the Inflation Reduction Act’s pill penalty that the industry says disincentivizes small molecule drugdevelopment. While PBMs are under scrutiny and facing new laws, pharma still suffers from a poor reputation and is facing several pricing policy issues of their own.
Drugdevelopment is more of a sprint than a marathon these days, thanks to more and better ways to target underlying biology and a more nuanced interpretation of precision medicine, three biotech leaders said at the STAT Breakthrough Summit East in New York Thursday. Continue to STAT+ to read the full story…
In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. WHO referred to 61 bacterial vaccine candidates in diverse stages of clinical development.
in drugdevelopment. Other members included industry executives, researchers, and FDA staffers, among them Vinay Prasad, the FDA’s top vaccine and biologics official. The risk was 0.2% in people taking GLP-1s and 0.1% in those who did not.
Given the large unmet clinical need in this oncology indication and aligned with recent clinical trial progress, the Triple Negative Breast Cancer (TNBC) DrugDevelopment Digital Summi t has been created to provide insight into industry- and academic-led clinical programs developing immune checkpoint, DDR inhibitor, ADC and other novel agents.
The new top regulator of vaccines and gene therapies at the Food and Drug Administration has never shied away from speaking his mind — whether in academic papers, on social media, or on a diary-esque Substack called “Vinay Prasad’s Observations and Thoughts. Not Vinay Prasad.
Moderna said Thursday it would cut its annual spending on research and development by 23%, or $1.1 billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate.
The UK has confirmed its support for global vaccination by pledging £1.25bn to global vaccine group Gavi while the US will halt funding to the international organisation. The Gates Foundation committed $1.6bn for the vaccine alliance, making it the second largest donor. Credit: speedshutter Photography via Shutterstock.
Since the first human administration of the Bacillus Calmette-Guérin vaccine in 1921, no one has been able to successfully follow the vaccine’s path to become the next approved vaccine to tackle tuberculosis (TB). However, as the TB-related death toll remains high, the global need for another vaccine is steadily rising.
Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. billion in deposits for the shot.
RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to developdrugs and vaccines for RSV with these populations in mind.
The Food and Drug Administration approved Wednesday a powerful new drug that provides nearly complete protection against HIV infection with just a single administration every six months.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, everyone. Damian here with what is my final edition of The Readout on my last day at STAT.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. About a month ago, when I first started writing this newsletter, I shared the devastating news that the famed rat hole here in Chicago was being removed.
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. A horse named Journalism was favored to win the Kentucky Derby, but lost to a horse named Sovereignty.
We’ve got a dramatic vote on psychedelic therapy, record drug shortages, bad (maybe?) Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Jason Mast here filling in for Elaine. news for Biomarin, and a new kind of PrEP.
For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval. Each designation offers specific benefits to the drugmakers.
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