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Based on a technology developed by Broad Institute core member David Liu’s laboratory, the treatment is the first in a series of new medicines being tested to treat rare diseases by repairing patients’ particular genetic misspellings. Some of these treatments, like K.J.’s, The team that treated K.J. Today, K.J. Today, K.J.
The work of June, Levine, Rivire, and Sadelain laid the foundation for a whole new class of treatments. In the early 2000s, both teams began preparing for clinical trials. Their contributions have saved lives and opened doors for future innovations that will continue to transform human health.
The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.
According to Takeda, oveporexton hit every main and secondary trial endpoint, helping improve patient-reported scores on measures of wakefulness, excessive daytime sleepiness, muscle weakness, and other symptoms after 12 weeks of treatment. You can unsubscribe at anytime. Takeda will file an approval application in the U.S.
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).
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™?
In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. 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.
2] [5] [6] Clinical trials In September 2023, the drug’s developer, Sorrento Therapeutics, announced top-line data that olgotrelvir had met its primary endpoints in a phase III clinical trial that enrolled 1,212 patients with mild or moderate COVID-19. L) solution of 1H-indole-2-carboxylic acid (compound 101) (200 g, 1.24
Ibtrozi was approved based on a pair of trials showing response rates of 90% and 85%, respectively, in patients who hadn’t previously received another tyrosine kinase inhibitor. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. You can unsubscribe at anytime. Registered in England and Wales.
Unfortunately, clinical results for many blood products made by Cohn’s team were inferior to other available treatment options, and perhaps that’s why his contributions to science have generally been forgotten. Developing processes at the pilot scale supplied more than enough human albumin for clinical trials, for example.
As stated, the primary focus of the Assessment is on chronic diseases, encompassing both their causes and their treatments. Indications for chronic diseases do not generally reflect the length of the clinical trial; FDA determines that clinical trials supporting such approvals are of sufficient duration and makes an approval determination.
Progress developing a treatment for leukemia led the company in 2021 to price a $177 million initial public offering. Data from that trial is expected in 2027. “I I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,” Kress said in a statement.
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).
“A big part of my role involves interacting with customers, learning from them on their challenges and providing solutions to expedite their path to clinical trials or commercialisation of their drug,” Galbraith explains. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.
In response, Sarepta stopped selling the treatment to these older, non-ambulatory patients, who it judges are at higher risk of treatment-induced liver damage. Among them are treatments for spinocerebellar ataxia, Huntington’s disease and facioscapulohumeral muscular dystrophy. Please select at least one newsletter.
Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Human constraints also play a role at a later stage, when clinical trials are involved.”
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. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. TechTarget, Inc.s
Millions of people around the world each year face serious illness, with the promise of groundbreaking treatment being just out of reach. 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.
Dive Insight: Lexeo is developing treatments for heart conditions, such as cardiomyopathy associated with Friedreich’s ataxia and plakophilin-2 arrhythmia. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. You can unsubscribe at anytime. Both programs are in early human studies. Can they keep it?
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.
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.
Alamy Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on which facilities can provide treatment.
Salicylic acid is likely the active compound that blocks the enzyme cyclooxygenase , giving aspirin its efficacy, and was used as a treatment for fever and gout before aspirin was developed. He treated fifty people over five years, all of whom he said were either cured or helped by the treatment. 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.
The COVID-19 pandemic brought mRNA to global prominence by developing highly effective vaccines by Moderna and Pfizer-BioNTech. The Expanding Role of mRNA in Cancer Therapy One of the most exciting applications of mRNA therapeutics lies in cancer treatment, where leveraging the immune system to target tumors offers a novel approach.
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.
Researchers from Edith Cowan University (ECU) are leading ground-breaking global trials which could save lives by changing how we treat cancer in the near future.
By Ayako Wakatsuki Pedersen, SVP of Translational Research at IO Biotech | Historically, most cancer vaccinetrials have fallen short. What is the potential of new vaccines that can dismantle cancer cells' defenses?
Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. The company is set to charge between $32 and $37 per dose.
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.
Global trials for AstraZeneca’s much-hyped COVID-19 vaccine, currently in development in partnership with the University of Oxford, have been halted after an unexplained illness was identified in one of the participants. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.
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.
The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. g of CoVLP are administered 21 days apart.
November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov.
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccinetrial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.
Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.
The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccinetrial may not have been caused by the treatment itself, according to newly revealed information. . The trials testing the vaccine have resumed in Britain, Brazil and South Africa after they were initially paused on 6 September.
The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,
Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.
mRNA vaccines are developing very quickly with dozens of ongoing clinical trials against cancers or infectious diseases (e.g. Recombinant monoclonal antibody (mAB) based treatments have proven their efficacy. Pre-clinical and clinical trials […] HIV or more recently SARS-Cov-2).
More recently, the FDA announced regulatory approval for the first treatment for Covid-19. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.
Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).
In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.
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