Drug Development and Vaccines - Pharmacist Digest

STAT+: Vaccine developer raises $45M for influenza drug trial

STAT

JUNE 24, 2025

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.

Vaccines

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As its cancer vaccine moves through the clinic, Transgene sets sights on manufacturing

PharmaVoice

JULY 9, 2025

Today, we’re speaking to Simone Steiner, Transgene’s new chief technology officer, about how the company is transitioning from early- to late-stage testing and advancing its manufacturing capabilities Oncology vaccines are gaining traction in the clinic as potential game changing treatments for cancer.

Vaccines

STAT+: Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies

STAT

MAY 6, 2025

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.

Vaccines

‘Last roll of the dice’ for a near-term HIV vaccine fails

STAT

DECEMBER 6, 2023

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…

Vaccines

STAT+: Cancer vaccines gain momentum, after years of disappointing results

STAT

APRIL 10, 2024

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.

Vaccines

STAT+: RFK Jr.’s latest moves on vaccines

STAT

MAY 29, 2025

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.

Vaccines

FDA offers new guidelines for Covid-19 vaccine

STAT

JUNE 17, 2024

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…

Vaccines

Does Moderna’s RSV vaccine lose efficacy faster than others?

STAT

FEBRUARY 9, 2024

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…

Vaccines

Implications of RFK Jr.’s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry

PharmaTech

JUNE 10, 2025

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.

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Moderna’s plan to make a single vaccine for Covid, influenza, and RSV is on track

STAT

OCTOBER 5, 2023

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…

Vaccines

Replicate’s srRNA rabies vaccine effective in Phase 1

STAT

FEBRUARY 14, 2024

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…

Vaccines

STAT+: After missing vaccine glory in pandemic, GSK looks to dominate other diseases

STAT

JUNE 7, 2023

BOSTON — GSK has been developing vaccines 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.

Vaccines

An easier path for makers of seasonal flu vaccines

STAT

MARCH 3, 2025

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…

Vaccines

Digital innovation drives vaccine development

pharmaphorum

JANUARY 31, 2022

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 vaccine development. Innovative new vaccines are being created more rapidly than ever before.

Vaccines

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DoH – Abu Dhabi and Sanofi link for vaccine development

Pharmaceutical Technology

JUNE 20, 2025

The Department of Health – Abu Dhabi (DoH) and Sanofi have signed a memorandum of understanding (MoU) to bolster vaccine development by leveraging local health-tech ecosystems and research infrastructure. Credit: Department of Health Abu Dhabi.

Vaccines

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Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit

pharmaphorum

DECEMBER 6, 2022

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.

Vaccines

Navigating uncertainty: the future of vaccine oversight amid CDC firings

Pharmaceutical Technology

JUNE 25, 2025

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 vaccine developers and manufacturers. Go deeper with GlobalData Reports ESG (Environmental, Social, and Governance) in Healthcare - Themati.

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CureVac and GSK try again with COVID-19 vaccine

pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up.

Vaccines

Allucent to expedite Covid-19 booster vaccines development

Pharmaceutical Business Review

AUGUST 28, 2023

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.

Vaccines

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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

APRIL 24, 2023

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.

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DelSiTech Awarded a Grant to Develop Controlled and Sustained Release Injectables for Prophylactic HIV Vaccine

Pharmafile

MARCH 15, 2023

Turku, Finland – March 15, 2023 – DelSiTech Ltd, a Finnish drug delivery and drug development 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.

Vaccines

Influenza vaccine 2 by Shanghai Institute of Biological Products for Pandemic Influenza: Likelihood of Approval

Pharmaceutical Technology

JUNE 10, 2023

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

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Influenza vaccine 2 by Shanghai Institute of Biological Products for Pandemic Influenza: Likelihood of Approval

Pharmaceutical Technology

JUNE 10, 2023

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

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STAT+: Dreams of cancer vaccines are becoming more real. Here are 9 scientists making it happen

STAT

OCTOBER 29, 2024

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.

Vaccines

London Biotechnology Show 2025: Novo Nordisk harnesses AI/ML to accelerate drug development landscape

Pharmaceutical Technology

JUNE 20, 2025

In recent years, the pharmaceutical industry has exhibited a significant shift into digitalisation, with AI pushing for innovation across the entire drug development value chain, from accelerating drug discovery to optimising clinical trial design to ultimately improve patient outcomes.

Drug Development

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Locked in a federal stalemate, states take PBM reform into their own hands

PharmaVoice

JUNE 16, 2025

For example, pharma lobbyists are pushing for a fix to the Inflation Reduction Act’s pill penalty that the industry says disincentivizes small molecule drug development. 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.

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A rare Marburg outbreak sparks a race against time to test vaccines and drugs

STAT

FEBRUARY 14, 2023

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.

Vaccines

STAT+: Life science leaders on how to make drug development less expensive, slow, and risky

STAT

MAY 7, 2024

Drug development 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 drug development.

Drug Development

STAT+: Drug development was once a marathon. New tools and timelines are turning it into a sprint

STAT

MARCH 22, 2024

Drug development 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…

Drug Development

Accelerating AMR vaccine development

European Pharmaceutical Review

NOVEMBER 1, 2023

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.

Vaccines

STAT+: Pharmalittle: We’re reading about GLP-1 drugs and eye disease, European pharma reforms, and more

STAT

JUNE 6, 2025

in drug development. 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.

Diabetes

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Triple Negative Breast Cancer Drug Development Digital Summit

pharmaphorum

FEBRUARY 10, 2021

Given the large unmet clinical need in this oncology indication and aligned with recent clinical trial progress, the Triple Negative Breast Cancer (TNBC) Drug Development 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.

Drug Development

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STAT+: Vinay Prasad, in his own words, outlines the philosophy he’ll bring to the FDA

STAT

MAY 6, 2025

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.

Vaccines

STAT+: Moderna touts research progress as it cuts R&D spending by $1.1 billion

STAT

SEPTEMBER 12, 2024

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.

Drug Development

UK steps up with £1.25bn Gavi vaccine pledge as US funding disappears

Pharmaceutical Technology

JUNE 26, 2025

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.

Vaccines

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Pharma Fix: The quest for the next tuberculosis vaccine

Pharmaceutical Technology

MARCH 24, 2023

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.

Vaccines

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Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

pharmaphorum

OCTOBER 30, 2020

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.

Vaccines

Race to the finish: pharma edges closer to approval with RSV vaccines

Pharmaceutical Technology

FEBRUARY 1, 2023

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 develop drugs and vaccines for RSV with these populations in mind.

Vaccines

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HIV protection with just two shots a year: FDA approves Gilead drug

STAT

JUNE 18, 2025

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.

Vaccines

Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmaTech

JULY 4, 2025

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines Feliza Mirasol April 30th 2024 Podcast In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Dosage

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GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

JANUARY 23, 2025

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.

Drug Development