This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
They intend to develop vaccines that provide lasting immuneresponses compared to existing vaccines. In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide.
The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immuneresponse and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. for serogroup W to 20.5
Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. The post Chinese tech giant Baidu licenses mRNA algorithm to Sanofi appeared first on.
The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.
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 post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on. billion product at peak.
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.
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. Overall, the global CAR-T cell market for all indications was worth $1.7
a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. , No other terms were disclosed.
In March, once the worst of the crisis was passed and COVID-19 vaccines entered regular commercial trade with producers competing for the booster shot market, Moderna said it was time to update its pledge and start to enforce its IP rights. The post Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit appeared first on.
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.
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.
billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. The biotech says this can stimulate both B cell (antibody) and T cell immuneresponses with a single shot. GlaxoSmithKline has agreed a $3.3
The function of the adjuvant is to market the body’s immune reaction. Our results show that the candidate vaccine formulation is safe, produces rapid immuneresponses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan.
In the UK, structural problems of the AIM market have compounded these problems by driving institutional investors away from relatively illiquid shares. Conventional vaccines introduce an inactivated sample of a disease to patients with the aim of stimulating an immuneresponse. COVID-19 sparks change.
Among the claims is that Comirnaty was developed using a chemical modification to prevent causing an unwanted immuneresponse in patients which was discovered by Moderna scientists, and that the use of a lipid nanoparticle formulation also infringes its intellectual property.
ImaginAb has signed a deal with Pfizer, which it hopes will help it to gather information necessary for approval of its tumour imaging agent as a medical device in markets in the US and other countries.
MicroRNAs are smaller than the small interfering RNA (siRNA) drugs now reaching the market, such as Alnylam’s Onpattro (patisiran), Givlaari (givosiran) and Oxlumo (lumasiran) for rare diseases. Regulus meanwhile remains a microRNA player, but has suffered a number of setbacks.
In preclinical testing, its TRACTr drugs have been shown to offer the same anti-tumour activity as older T-cell engager drugs, but don’t cause the release of cytokines that can lead to a runaway immuneresponse and damage to healthy tissues. The post Merck cuts $1bn deal with Janux for cancer T-cell therapies appeared first on.
Merck also sells an older shot called Pneumovax 23, which covers 23 serotypes but is based on an older polysaccharide technology that does not stimulate the immuneresponse as strongly as the newer conjugate vaccines. Those eight strains account for more than 30% of the disease burden caused by S pneumoniae , said the drugmaker.
The biotech is also following a second line of development for plinabulin as a cancer treatment, based on research showing the drug can boost cell-based immuneresponses to tumours. The post BeyondSpring faces a tough winter as FDA rejects its lead drug appeared first on.
It also developed the first single-dose drug therapy that can be used to eradicate malaria caused by Plasmodium vivax – tafenoquine – and is working on an improved TB vaccine which has been licensed to the Bill & Melinda Gates Foundation. The new unit will operate on a non-profit basis, said GSK in a statement.
The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immuneresponse after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5).
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., More than 45 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 170 million doses of the vaccine have been distributed since 1976.
All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immuneresponses following the second dose of INO-4800.
The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immuneresponses.
.
One consideration in using syngeneic models is that some drug candidates can cause a negative immuneresponse not seen in humans. Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. About Taconic Biosciences, Inc.
Source link.
Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. It is also entering late into the market. billion ($1.5
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. Download this exclusive report here.
The influenza virus is subject to constant mutations to evade the host immuneresponse, causing a seasonal variation in circulating strains. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
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. We are committed to implementing similar requirements in other markets wherever possible.
CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immuneresponse is unknown, and there appears to be no identifiable genetic predisposition to CIDP. Researchers estimate that the incidence of CIDP in the US ranges from 0.8
The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. VLA15 has demonstrated a strong immuneresponse and satisfactory safety profile in pre-clinical and clinical studies so far.
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?
In November , the European Medicines Agency agreed to review the Marketing Authorization Application for avacopan for the treatment of patients with ANCA-associated vasculitis. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems. Oral, Small Molecules.
We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immuneresponses to eradicate the tumor cells. Amorette Barber of Longwood University will be heading up our chPD1 program.
The analysis was prospectively designed to focus on patients who had not yet mounted their own immuneresponse to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.
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.
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. trial and we look forward to sharing T cell immuneresponse data from the German trial in the near future.”. “It View the full release here: [link].
Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. Graphite Bio licensed the product from Stanford University. The trial is evaluating the safety and efficacy of VIR-7831 in hospitalized COVID-19 adults.
Based on the acceptable safety profile and the favorable immuneresponse data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. 20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein].
29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. NEW YORK, Oct.
On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. What’s more, VAX-24 achieved a higher immuneresponse to 16 of the 20 serotypes it shares with Prevnar 20.
“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immuneresponse at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immuneresponse of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .
. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content