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Coya Therapeutics has expanded its patent estate for COYA 301 by entering a licensing agreement with UNeMed, the University of Nebraska Medical Center’s technology transfer office. This suggests that the interventional strategy may lead to sustained suppressive immuneresponses and neuroprotection in PD.
In the Phase II trials, adult participants received a single Nuvaxovid booster dose six months after their initial two-dose vaccine doses. The findings showed that the Nuvaxovid booster dose increased immuneresponses compared to higher levels associated with the protection in Phase III clinicaltrials.
Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immuneresponse against the cancer. The two companies are also running a phase 3 trial of the bispecific as a monotherapy in patients with relapsed/refractory diffuse LBCL.
Like with small molecules, clinicaltrials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinicaltrial sites run by a third-party clinicaltrial site operator.
Sanofi and Translate Bio initiate Phase 1 clinicaltrial of mRNA influenza vaccine. Th e first clinicaltrial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.
As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.
It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immuneresponse is needed to fend off the disease. Malaria Vaccine Phase II Trial. percent who received the rabies vaccine developed clinical malaria.
Clinicaltrial to assess safety, immuneresponse and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinicaltrial.
billion licensing agreement with Werewolf Therapeutics that adds its first immuno-oncology candidate. It was shown to activate cell-killing immuneresponses via natural killer (NK) and CD8+ cells, as well as antigen-presenting cells. Jazz Pharma has bolstered its pipeline of cancer drugs through a $1.3
a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinicaltrials. LOS ANGELES , Jan.
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, The inhalant version.
ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S
Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immuneresponse as compared to the vaccines using one and the same vector for two doses.”. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.
The concept behind this form of treatment is that the introduction of these cells will enhance the immuneresponse to disease, often through bioengineering the immune cells to have improved functionality and characteristics, such as longer half-lives. These cells can be taken originally from the patient or another individual.
The common challenge is undertaking lengthy and capital-intensive phase II/III clinicaltrials. For example, if a company is carrying out clinicaltrials, then a clinical research organisation is needed to run them. Companies have struggled to access intermediate capital. If we get it right, the prize is great.
a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.
Investigation of the possibility of VAED is crucial during clinicaltrials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinicaltrial phases.
The study compared the immuneresponses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. After more than 50 years of research, we are closer than ever to having a licensed CMV vaccine,” Permar said.
Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. In recent years, several other medications have entered Phase II/III clinicaltrials for the treatment of ALS. What is SOD1 -ALS?
Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.
million ($22 million) in second-round financing as it prepares to start clinicaltrials of its lead drug candidate INT-1B3 for solid tumours. InteRNA’s clinicaltrial will start with a dose-escalation phase in which subjects with advance cancer will receive a 60-minute infusion twice a week in 21-day cycles.
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. .
Vera Therapeutics bags USD 80 Million for trials. Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinicaltrial. The drug, atacicept, has flunked multiple autoimmune clinicaltrials, but Vera contemplates that it is a prospect in IgA nephropathy.
Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ”
Findings from the Phase 1 ClinicalTrial.
mg and 2.0
In a complete response letter (CRL), the FDA said that it would need a second clinicaltrial of plinabulin before it could consider approving the drug, setting up what looks like a lengthy delay for the programme.
Novavax will present data from an ongoing Phase I/II clinicaltrial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. Other Industry News.
Delivery of viral antigens in potent vaccine vectors to elicit a strong immuneresponse is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. This press release features multimedia.
Pfizer’s newest and updated COVID-19 vaccine trial results from its ongoing Phase III clinicaltrial confirms that protection lasts at least six months after administration of the second dose. 1.351 variant, which may have the potential to evade the immuneresponse.
Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.
The influenza virus is subject to constant mutations to evade the host immuneresponse, causing a seasonal variation in circulating strains. Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection. a 3-dose primary series to individuals 6 months through 4 years of age.
About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S., In clinicaltrials, the safety and immunogenicity of TICOVAC were assessed across two age groups (1-15 years of age and >16 years of age). in 1-15 year olds and 98.7-100%
Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Our ClinicalTrials and Research. All of our U.S. Global Relief Efforts.
SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinicaltrial sites in the U.S. Small Molecule Inhibitors. Anti-CD40L Antibody.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinicaltrials is causing widespread concern. This means that the vaccine is not being delivered as licensed. Just received this email cancelling my 2nd dose of the Pfizer vaccine. Industry support.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinicaltrials is causing widespread concern. This means that the vaccine is not being delivered as licensed. Just received this email cancelling my 2nd dose of the Pfizer vaccine. Industry support.
“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinicaltrials prove successful and regulatory approval is granted.”. “As billion doses by the end of 2021.
producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial.
As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.
Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinicaltrials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. What Is a Surrogate Endpoint?
AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinicaltrial. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. About AstraZeneca.
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 companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immuneresponses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. This press release features multimedia. View the full release here: [link].
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