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Falling out of fashion with the rise of the modern pharmaceutical industry, it’s ready for a comeback driven not by mania, but rather by a mechanistic understanding of the molecules and bioactive compounds responsible for its efficacy. A History of Fermentation.
The UK government has signed deals for a further 90 million doses of coronavirus vaccine. The vaccines are being developed by the Belgian pharmaceutical company Janssen and the US biotech company Novavax. Inactivated whole virus vaccines: 60 million doses Valneva. Image copyright. Most of the vaccines require only two.
This week, another pharma company revealed a new technology device that can detect if a patient is infectious or not, while the Russian government published results of its Sputnik V vaccine, claiming it is more than 95 per cent efficient 42 days after the first dose. Read on to for the full insight.
Regeneron Pharmaceuticals, Inc. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes.
22, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. Nasdaq:BCRX) today announced that data from part 1 of a clinical trial of its broad-spectrum antiviral, galidesivir, showed that galidesivir was safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19.
REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic.
15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. President and Chief Executive Officer of Tonix Pharmaceuticals.
For example, pharmaceutical regulatory bodies are working tirelessly to fast track the approval of vaccines to treat Covid-19, doctors are now better prepared to handle patients with coronavirus and testing is becoming faster and more accessible. The New Year brings new hope as UK regulators approve Oxford vaccine for emergency use.
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announced that Health Canada has granted approval for COVIFENZ®, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID?19)
Regeneron Pharmaceuticals, Inc. About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. TARRYTOWN, N.Y. ,
A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. For more than 170 years, we have worked to make a difference for all who rely on us.
This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.
Bill Anderson, chief executive officer of Roche Pharmaceuticals, said: “We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN -COV2 could be a critical line of defense against the Covid-19 pandemic.”.
Patrick Soon-Shiong MD, chairman and CEO of ImmunityBio, said: “There is an urgent need for a vaccine that not only offers immediate protection but also activates T cells to clear the virus. When multiple mutations occur at the receptor-binding domain of the spike protein, it renders antibodies ineffective. Source link.
These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group. The neutralizing GMT against the wild-type virus was 2153 (after three doses), compared to 335 after two doses. Source link: [link].
WHO is closely monitoring 10 Covid variants as virus mutates around the world ( CNBC ) .
World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments ( Pink Sheet ).
World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments ( Pink Sheet ).
04, 2021 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, announced today that its subsidiary, InspirMed Inc., TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.
Bayer AG’s decision to join forces with CureVac and help produce the vaccine is another crucial step in the fight against the virus,” said State Premier Laschet. The pharmaceutical and biotechnology site in Wuppertal offers ideal conditions for the high-tech, complex process of vaccine production.”.
17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19.
–( BUSINESS WIRE )– Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, announced today that it has priced an underwritten public offering of 5,400,000 shares of common stock at a public offering price of $14.00 About Syros Pharmaceuticals. 20, 2021 03:41 UTC.
Forward-Looking Statements and Use of Digital Media This statement includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking (..)
The new vaccine is made up of a deactivated cold virus into which scientists cut-and-paste a genetic version of the “spike” protein used by the coronavirus to infect cells. The pharmaceutical giant pledged in its $1 billion contract with the U.S. The pharmaceutical giant pledged in its $1 billion contract with the U.S.
“While the results of this particular clinical trial are disappointing, we are proud that as an industry we proactively and collaboratively pursued this work, and that the program may contribute to a growing understanding of this challenging virus and strategies for patient care.
BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. About the Phase 2/3 Study. In the late-stage trial, Pfizer and BioNTech are studying a 30µg dose level in a 2-dose regimen among up to 30,000 participants aged 18 to 85 years. billion doses by the end of 2021.
The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.
–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?) Source: Syros Pharmaceuticals.
The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.
Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide. For more information, please visit www.BioNTech.de.
Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more information, please visit www.BioNTech.de.
Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. 6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients.
Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
Molecular Partners two antiviral DARPin® candidates, MP0420 and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. About Molecular Partners’ anti-COVID-19 program. About DARPin® therapeutics.
FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. The PDUFA VII Commitment Letter describes the agreed-upon standard review times for most drug products.
Government to supply doses in 2020 & 2021.
The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately.
Manufacturing and Delivery Capabilities.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. For more than 150 years, we have worked to make a difference for all who rely on us.
29, 2020– Alexion Pharmaceuticals, Inc. We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. ALEXION PHARMACEUTICALS, INC. ALEXION PHARMACEUTICALS, INC.
The amendment would make clear that the establishments that manufacture HCT/Ps regulated as devices are required to follow the registration and listing procedures in 21 CFR part 807. The following PDUFA dates were obtained from publicly available sources.
We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. “The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials.
Regeneron Pharmaceuticals, Inc. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. million doses.
OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), announced today that it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. About Takeda Pharmaceutical Company Limited.
For instance, the influenza virus is notorious for its ability to undergo antigenic drift, accumulating mutations in its surface proteins that can render existing vaccines less effective. Even after a vaccine is approved and distributed, the pharmaceutical industry's responsibility does not end.
The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. 3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.
government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. government will accept the vials of bamlanivimab if it is granted an Emergency Use Authorization (EUA) by the U.S. Supply agreements with governments – such as this one with the U.S.
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