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Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). Also recently, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committe turned down a stem cell treatment for amyotrophic lateral sclerosis, aka ALS, Lou Gehrig’s disease, or motor neuron disease.
Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immuneresponse, can be highly variable and impact the safety and efficacy of the drug. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.
By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.
Antibody and T-cell immuneresponses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.
Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. and globally.”. About NVX-CoV2373. and Australia. Fast Track Designation by the U.S.
Food and Drug Administration (FDA) are starting to pick up. The NDA was built on data from the Phase III VICTORIA trial. We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”.
Can they deliver healing genes without triggering an overactive immuneresponse? The details are disturbingly reminiscent of the famous case of Jesse Gelsinger , who died from a ferocious immuneresponse to experimental gene therapy in September 1999. An immuneresponse is two-tiered.
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immuneresponse in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.
Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. Roughly 16.4
Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .
12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.
The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. Detailed results from the study will be shared at a future medical conference. Source link: [link].
“These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence,” they added. ” Changing the dosage could also hamper the U.S.
The combination of P1 with antiPD1 more efficiently activated innate and adaptive immuneresponses than either P1 or antiPD1 alone by re-energising T cell effector functions, thus providing the remarkable reduction of tumour growth in solid tumours and extended survival period.
However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.
Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. The FDA granted Regeneron’s antibody cocktail Emergency Use Authorization in November.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. ” The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. SILVER SPRING, Md. , Hahn , M.D.
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immuneresponse to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.
FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.
Food and Drug Administration (FDA). The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immuneresponse or who have high viral load.
The year is starting to pick up in terms of clinical trial announcements. Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing its single-dose COVID-19 vaccine candidate created an immuneresponse that lasted at least 71 days. Here’s a look at last week’s news.
Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. 24, 2020 ). Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.”.
Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.
5, 2021 — Stem cells derived from a baby’s umbilical cord can help save the lives of the sickest COVID-19 patients, results from a small new clinical trial suggest. TUESDAY, Jan. Half were randomly chosen to receive two separate IV infusions of 100 million stem cells, while the others received a placebo IV.
Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.
Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. If the vaccine receives the designation, the FDA will allow some people to receive the product as the agency continues to look at the data. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA.
FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. Days after the U.S.
Alipogene tiparvovec and voretigene neparvovec-rzyl, two recombinant AAV-based gene therapy products, were approved by the European Medicines Agency (EMA) to treat lipoprotein lipase deficiency in 2012 2 and by the US Food and Drug Administration (FDA) to treat inherited retinal dystrophy in 2017, respectively. Russell S, et al.
The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. Strong Th1 cell-mediated immuneresponses were also observed for the vaccine candidates with either adjuvant.
The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. On January 5, 2021, the U.S. Most Read Today.
Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immuneresponses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.
Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests. . In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19. Diagnostics.
While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immuneresponses. Biomarkers are the holy grail of clinical trials. References Chen GY.,
This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Prior to clinical trials, the focus is typically on evaluating safety. Can you identify a safe AND efficacious clinical dose?
Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??) The active IND enables the Company to initiate the first-in-human clinical trial to assess safety and efficacy of ADI-001 in NHL patients. T cell therapy in NHL patients.
The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.
FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.
Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immuneresponse. SAN CARLOS, Calif. ,
The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.
Many companies appear to be getting their clinical trial news updated ahead of the holidays. CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. From the initial diagnosis, patients have seven days to attempt to join the trial.
A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.
AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose.
Fortunately, some novel preventatives and therapies are in the works, including a vaccine equipped with adjuvants that efficiently prime the immune system and newer antibiotics against which the bacteria have yet to evolve resistance. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.
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