BioPharma Drive: Drug Pricing

MAY 27, 2025

The agency recommends manufacturers update their vaccines to target the JN.1 At the same time, HHS head Robert F. Kennedy Jr. is removing guidance that healthy children and pregnant women receive COVID shots.

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BioPharma Drive: Drug Pricing

JULY 16, 2025

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children.

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Drug Target Review

DECEMBER 9, 2024

Baker’s model could revolutionise drug development, synthetic biology, and nanotechnology, opening possibilities for new medical treatments, vaccines, nanomaterials, and sensors. The Rosetta algorithm has been incorporated into AI-powered tools like RoseTTAfold, which uses a three-track neural network to predict protein structures.

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BioPharma Drive: Drug Pricing

JULY 28, 2025

Most Popular 5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis Dispatch emerges with $216M and plans for a ‘universal’ solid tumor therapy FDA delays approval decision for Bayer menopause therapy Biotech startup funding dried up in second quarter, HSBC finds Library resources Infographic Tech Transfers: 5 CDMO Strategies to Speed Time (..)

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Broad Institute

JUNE 24, 2025

It also needed to be delivered directly to the liver cells in his body, rather than to cells in a lab, and this was achieved by packaging the base editor in a lipid nanoparticle, a delivery system conceptually similar to the one used to deliver COVID vaccines to billions of people. s mutation and may never be used to treat another person.

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Broad Institute

MAY 21, 2025

In the first patients treated in our trials, we realized that something very special was happening, said Levine, who is the Barbara and Edward Netter Professor in Cancer Gene Therapy and founding director of the Cell and Vaccine Production Facility at University of Pennsylvania.

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DrugBank

JUNE 18, 2025

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Most Popular Renasant Bio, chasing drugs for ADPKD, raises $55M in seed funding Merck to buy Verona and its lung drug in $10B deal FDA, in policy shift, publishes some drug rejection letters With Verona deal, Merck wagers on strength of lung drug’s patents Library resources Podcast Digital Behavioral Therapy for Fibromyalgia Custom content for Medrio (..)

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Alta Sciences

JULY 7, 2025

CAR T cells) WHAT IS THE BENEFIT OF NONCLINICAL CYTOKINE RELEASE EVALUATION?

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The Pharma Data

JUNE 13, 2025

This meant putting the fundamentals of mRNA production directly into the hands of local innovators — a dramatic departure from previous models that kept much of vaccine production within a small number of firms in high-income settings. mRNA Technology Transfer Programme Moves Into Phase 2.0, 2026–2030).

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The Pharma Data

JUNE 26, 2025

CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program. What Is ENFLONSIA™?

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The Pharma Data

JUNE 9, 2025

According to Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, the product has been administered to over 250,000 infants in real-world settings, backed by more than 40 studies demonstrating its effectiveness in preventing RSV lower respiratory tract disease.

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Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. These breakthroughs have significantly curbed cases, with vaccination reducing the odds of death by 74 percent. tuberculosis , to develop the vaccine.

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Drug Patent Watch

DECEMBER 17, 2024

Many organizations demonstrated remarkable adaptability, quickly pivoting to produce vaccines and therapeutics at unprecedented speeds. Case Studies: Flexibility in Action Let’s look at some real-world examples of how flexibility has made a difference in CDMO operations and client relationships.

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New Drug Approvals

JUNE 28, 2025

“Second Generation Oral Mpro Inhibitor for COVID-19 Treatment Proceeds in Phase 3 Study” Precision Vaccinations. Other examples of Mpro inhibitors in late-stage development include STI-1558, currently in the phase 3 clinical trial in adult subjects with mild or moderate COVID-19 (NCT05716425). Retrieved 27 December 2023.

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Clinical Trials Production Treatment Trials 57

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Most Popular National Resilience, a well-funded manufacturing startup, to scale back operations Concentra to acquire Elevation in bid to eliminate another biotech ‘zombie’ Vaccine makers face fresh uncertainty after firing of CDC panel Biotech funding plummets as Trump policies unnerve investors: Jefferies Library resources Podcast Pioneering Treatments (..)

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FDA Drugs Therapies Science 270

Covalent Modifiers

JULY 8, 2025

2025 [link] The coronavirus disease 2019 (COVID-19) pandemic crisis has been mitigated by worldwide efforts to develop vaccines and therapeutic drugs. However, there remains concern regarding public health and an unmet need for therapeutic options.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Codon

JANUARY 5, 2025

In the decades following the war, more conventional vaccines were also developed for the same diseases which gamma globulin inoculated against — measles and Hepatitis A. Human albumin administered to treat blood loss in soldiers was more shelf stable than, but clinically inferior to, both plasma and whole blood.

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Laboratories Science Production Research 105

FDA Law Blog: Biosimilars

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

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The Pharma Data

JULY 3, 2025

These services play a crucial role in the development of next-generation conjugate vaccines, antibody-drug conjugates (ADCs), activated polyethylene glycols (PEGs), and polymer-based drug delivery systems—therapeutic modalities that are rapidly gaining prominence in the pharmaceutical and biotechnology sectors.

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Science Pharmacokinetics Vaccine Production 52

The Pharma Data

JUNE 12, 2025

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech in Push for Global Health Equity GSK today announced a significant step forward in the battle against Shigella a leading cause of diarrhoeal disease and death in children under five by licensing its Shigella vaccine candidate, altSonflex1-2-3 , to Bharat Biotech International Limited (BBIL).

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.

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Drug Target Review

MAY 26, 2025

He also has two current external positions as a member of the Scientific Advisory Board for Refeyn, a technology innovation university spin out, and as chair of Glen Clova Scientific, an early-stage vaccine development company.

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Drug Development Drugs Therapies Pharmaceuticals 52

BioPharma Drive: Drug Pricing

JULY 16, 2025

Please select at least one newsletter.

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Therapies FDA Clinical Trials Licensing 304

Codon

NOVEMBER 1, 2024

Such models will, in turn, make it much easier to invent the sorts of platform tools that Amodei asserts “drive >50% of progress in biology,” such as CRISPR and mRNA vaccines, because the creation of these tools ultimately derive from a deeper understanding of how cells work.

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DNA RNA Molecular Biology Laboratories 132

BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

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BioPharma Drive: Drug Pricing

JULY 18, 2025

Most Popular Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks Novartis CEO says resolution on Trump plan to cut US drug prices will take time Moderna’s latest approval again reveals FDA rift over COVID vaccines Bristol Myers, Pfizer to offer Eliquis at a discount for some patients Library resources Case Study Safeguard Your (..)

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BioPharma Drive: Drug Pricing

JULY 18, 2025

Most Popular Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks FDA to ask Sarepta to stop shipping Duchenne gene therapy Novartis CEO says resolution on Trump plan to cut US drug prices will take time Biotech startup funding dried up in second quarter, HSBC finds Library resources Case Study Safeguard Your mAb Pipeline with (..)

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BioPharma Drive: Drug Pricing

JULY 10, 2025

By Jonathan Gardner • Updated April 9, 2025 Latest in Marketing Soleno sales of new Prader-Willi drug rise faster than expected By Ben Fidler Lilly gets FDA OK of modified dosing for Alzheimer’s drug By Jonathan Gardner Medical groups, pregnant doctor sue RFK Jr.

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Drugs.com

JULY 23, 2025

WEDNESDAY, July 23, 2025 — Cancer patients can be very vulnerable to a severe COVID infection, but COVID-19 vaccine boosters can be lifesavers for them, a new study says. COVID boosters reduced cancer patients’ hospitalizations and ICU.

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Drugs.com

JULY 25, 2025

FRIDAY, July 25, 2025 — It's official: The controversial preservative thimerosal will be stripped from all flu vaccines distributed in the United States. According to the CDC, influenza (flu) vaccines are currently available in both.

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Vaccine 212

Drug Target Review

MAY 5, 2025

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. The COVID-19 pandemic highlighted these issues on a global scale. It forced the healthcare industry to rethink its limitations and embrace change.

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Clinical Development Drug Development Therapies Science 52

ProRelix Research

JUNE 16, 2025

While vaccines, therapeutics, and preventive measures have significantly reduced the global burden of the disease, […] The post COVID-19 in 2025: Are Decentralized Clinical Trials the New Standard? The world continues to feel the ripple effects of the COVID-19 pandemic, even into 2025. appeared first on ProRelix Research.

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Drugs.com

JUNE 16, 2025

MONDAY, June 16, 2025 — Kidney damage is common during a severe case of COVID-19, but vaccination appears to protect people against this life-threatening side effect, a new study says. Unvaccinated COVID patients with kidney damage severe enough to.

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Drugs.com

MAY 19, 2025

Food and Drug Administration (FDA) has granted full approval to Novavaxs COVID-19 vaccine, but only for certain people.The vaccine is now approved for adults ages 65 and older, or for people ages 12 to 64 who have at. MONDAY, May 19, 2025 The U.S.

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BioPharma Drive: Drug Pricing

MAY 20, 2025

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

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