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In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response 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. Ugur Sahin, M.D.,
Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including smallmolecules, vaccines, cell and gene therapy products, biologics, etc.), As the U.S.
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S.
The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within 3 days after the infection. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. Jansen, Ph.D.,
BioNTech SE (Nasdaq: BNTX, “BioNTech”) has taken a next step to improve vaccine supply in Africa. The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution.
times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. Jansen, Ph.D.,
Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics.
Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19.
CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al.
Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5,
Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin—“attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing smallmolecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both smallmolecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to smallmolecules, biologics and biosimilars.
Similarly, about 40 percent of people with a deficiency in either IRAK-4 or MyD88 — key signaling molecules just downstream of the pattern recognition receptors — die before reaching adulthood, despite receiving vaccines, antibiotics, and advanced medical treatment. Creating Countermeasures Vaccine development can be fast.
With a focus on immuno- inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to smallmolecules, biologics and biosimilars.
CIBINQO (abrocitinib) is an oral smallmolecule that selectively inhibits Janus kinase (JAK) 1. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. About CIBINQO ® (abrocitinib).
Extra pieces of data, including proteins, lipids, or smallmolecules, are helpful when a particular DNA sequence is difficult to amplify or isolate from a sample, or when sequencing results don’t point squarely at a single disease-causing organism. New Yorkers wait to receive a monkeypox vaccine.
With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to smallmolecules, biologics and biosimilars.
With a diversified technology portfolio, EUROAPI is positioned as the world’s leading manufacturer of smallmolecule API (including complex chemical synthesis molecules, biochemical molecules from fermentation and highly potent molecules). Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.
at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. government fiscal year runs from October 1 – September 30. CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As a reminder, the U.S.
We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). Ovid’s most advanced pipeline programs include OV935 (soticlestat) in collaboration with Takeda and OV101 a ?-selective
Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The term microbiome differs from “microbiota,” which describes the specific micro-organisms that are harbored by the human body.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.
billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization.
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date.
by the middle to end of December 2020. participants are 56-85 years of age.
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.
.
Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.
Jansen, Ph.D.,
To survive this era, governments, multi-lateral organisations, foundations, and industry will need to work collectively on researching and developing new drugs that can prevent or treat a broad range of epidemic-prone pathogens, some of which have not yet been identified. Vaccines, however, do have some critical limitations.
• Submission based on real-world safety and efficacy data from Israel • Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster.
If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About Pfizer: Breakthroughs That Change Patients’ Lives.
Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S.
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
According to Citeline , there are 160 ALS studies planned or ongoing in 2024 with various sponsors such as academia, consortia, government, and industry, not including studies in HV populations. However, work is needed before CRISPR-mediated treatments become possible, including a better understanding of the genes involved in ALS.
Pfizer scientists will also collaborate with AWS healthcare and life sciences professionals to explore how researchers in Pfizer’s Pharmaceutical Sciences SmallMolecules teams can extract and mine information from legacy documents by leveraging AWS analytics and machine learning services.
— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.
About BRAFTOVI + MEKTOVI BRAFTOVI is an oral smallmolecule BRAF kinase inhibitor and MEKTOVI is an oral smallmolecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK). For more than 170 years, we have worked to make a difference for all who rely on us.
Abrocitinib is an oral smallmolecule that selectively inhibits Janus kinase (JAK) 1. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. About Abrocitinib.
Abrocitinib is an oral smallmolecule that selectively inhibits Janus kinase (JAK) 1. VACCINATIONS. Avoid use of live vaccines concurrently with XELJANZ. We look forward to hearing from the FDA as we work to bring these important potential treatment options to the appropriate patients.”. About Abrocitinib.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.
CGRP Receptor Antagonism Smallmolecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.
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