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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.
ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs pmjackson Mon, 07/07/2025 - 21:31 New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS).
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).
Ibtrozi has also shown the ability to help people whose cancer has spread to the brain, a leading cause of disease progression, the company said. You can unsubscribe at anytime. In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million.
Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Now, Vor is reestablishing itself as an autoimmune disease company. You can unsubscribe at anytime. Europe and South America, according to the companies.
The same team also invented several other products that proved useful for treating battlefield injuries, including gamma globulins to inoculate soldiers against diseases and fibrin film to minimize bleeding during brain surgeries. Still, Cohn’s work ought to be iconic amongst those interested in scientific progress and metascience.
The Strategy must address appropriately restructuring the Federal Governments response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.
On a conference call held Wednesday afternoon, Sarepta CEO Doug Ingram said that "failure to adapt" to recent setbacks "would risk our long-term viability as an organization and decrease the opportunity to bring the greatest benefit to the greatest number of patients living with rare disease." You can unsubscribe at anytime. Will RFK Jr.
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.
Spencer Platt via Getty Images The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. The disease, which affects an estimated 10,000 to 20,000 people in the U.S., You can unsubscribe at anytime.
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 Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.
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 Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.
Permission granted by Incyte Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who led the cancer and blood disease drugmaker for the past 11 years. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.
Collaborative Surveillance Strengthening disease surveillance remains a central pillar of the response. Tailoring vaccination approaches to local epidemiology using strategies such as fractional dosing during supply shortages. Integrating vaccination efforts with surveillance and contact tracing operations.
The high-level event, organized by the G20 Health & Development Partnership and co-hosted by the World Health Organization (WHO), brought together G20 policymakers, international health experts, and key private and public sector stakeholders to reimagine the future of global health and finance.
And some of the remedies are still practiced today: the treatment for Guinea-worm disease was, and still is , to wrap the emerging end of the worm around a stick and slowly pull it out. This version of events was first reported in a footnote in a 1934 book on the history of chemical engineering. 4 A reproduction of the Ebers Papyrus.
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 News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront. .
Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. He also specifically mentioned rare diseases here , in addition to his example of late-stage illnesses.
The event marked a turning point for civil society’s formal inclusion in global health decision-making, a movement that has been gradually gaining momentum but found new institutional strength at WHA78. These submissions spanned a wide range of health issues, from equitable vaccine access to financing for resilient health systems.
In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.
Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme diseasevaccine candidate, VLA15.
Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies.
Anaphylaxis Cases Reported Per Million COVID-19 Moderna Vaccine Shots. cases per million Moderna COVID-19 vaccine doses administered as of Jan. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. anaphylaxis cases per million Moderna COVID-19 vaccine doses administered). Professional.
The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.
Anaphylaxis Cases/Million Doses of Pfizer-BioNTech COVID-19 Vaccine Reported. per million doses administered) after receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine in the United States, according to research published in the Jan. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,
Moderna COVID-19 Vaccine Protection May Last Years, Company Claims. 8, 2021 — Moderna CEO Stéphane Bancel said the company’s COVID-19 vaccine may prevent infection for years, CBS News reported Thursday. Professional. FRIDAY, Jan. Natural immunity varies from person to person, CBS News reported. CBS News Article.
government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country.
21, 2021 — Despite scattered media reports of severe allergic reactions to the Pfizer COVID-19 vaccine, a detailed analysis shows that such incidents are very rare, striking just 11 people for every million doses given. Tom Shimabukuro tracked data on reactions to the Pfizer vaccine soon after it was approved in December.
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.
11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however. FRIDAY, Dec.
Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]). To date, AstraZeneca and its partners have supplied more than 1.1 Vaxzevria (ChAdOx1-S [Recombinant]).
million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 vaccines. The work is supported by the Centers for Disease Control and Prevention (CDC). “The world is relying on safe and effective vaccines to bring an end to the COVID-19 pandemic. . The total number of people evaluated was 6.2
Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “
23, 2020 — The novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19, is well tolerated, especially among older adults, according to a study published online Nov. During the study period, 13 serious adverse events occurred, none of which were considered to be related to the study vaccine. MONDAY, Nov.
FreVAX is an innovative intramuscular needle free vaccine injection device for pigs around weaning until the end of nursery. to provide improved vaccination compliance and data management,” added Marius Leyhausen, Senior Global Brand Manager, Integrated Health Management at Boehringer Ingelheim Animal Health. The FreVAX app 2.0
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.
30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.
Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. GAITHERSBURG, Md., Glenn, M.D., and globally.”.
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
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