Search Results for “antibody” – Page 57 – media

Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
- Source: drugdu
- 125
- June 5, 2023
Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
- 115
- June 4, 2023
CPhI Worldwide Europe

CPhI Worldwide Europe is a famous brand exhibition in the field of international pharmaceutical raw materials, as well as a professional exhibition in the field of pharmaceutical raw materials and intermediates. The show travels annually between France, Germany and Spain.CPhI World pharmaceutical raw materials, P-MEC pharmaceutical machinery, InnoPack pharmaceutical packaging materials and ICSE contract customization will be held at the same time, realizing four exhibitions in one, becoming a great gathering of the global pharmaceutical industry, in addition to zero distance to understand the latest technology application and product information, the development direction of the pharmaceutical industry, but also play a role in the weather.
- Source: drugdu
- 1,054
- June 1, 2023
Cats can play a role in transmitting COVID-19, finds new study

Cats can play a role in the transmission of SARS-CoV-2 and their contaminated environment (pens in this study) can be infectious, according to new research. The study is published in Microbiology Spectrum. “In practice, after the introduction of SARS-CoV-2 in our household, we should see our cat as part of the family regarding virus transmission,” said study co-author Wim van der Poel DVM, Ph.D., Professor of Emerging and Zoonotic Viruses, Wageningen University and Research, in the Netherlands. Dr. van der Poel and colleagues conducted the study to gain better insight into the risk of COVID-19 infection that could arise from cats infected with SARS-CoV-2. In the study, 16 cats were either directly exposed to SARS-CoV-2 virus obtained from a naturally infected human patient, exposed indirectly from a directly exposed cat, or exposed from the pen in which an infected cat was housed. All cats were regularly sampled during the whole ...
- Source: drugdu
- 138
- June 1, 2023
Study maps immune responses produced by COVID-19 vaccination in First Nations population

Published in Nature Immunology and Nature Briefing, the research is the first of its kind to decisively map immune responses produced by a COVID-19 vaccination in any First Nations populations. In partnership with Menzies School of Health Research, researchers at the Peter Doherty Institute for Infection and Immunity (Doherty Institute) evaluated immune responses in Aboriginal and Torres Strait Islander peoples and non-Indigenous individuals after receiving the mRNA COVID-19 vaccine. Lead author of the study and PhD candidate at the Doherty Institute, University of Melbourne’s Wuji Zhang, said the research provides strong evidence that COVID-19 vaccination triggers effective immune responses against the virus in First Nations peoples. “We found excellent antibody and T cell responses against SARS-CoV-2 in Australian First Nations peoples following COVID-19 vaccination. We saw high levels of antibodies binding to the virus following two vaccine doses,” Mr Zhang said. “T cells against the spike protein, which often recognize ...
- Source: drugdu
- 118
- May 31, 2023
AbbVie and Genmab’s blood cancer therapy granted FDA accelerated approval

AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
- Source: drugdu
- 117
- May 24, 2023
Phase I trial demonstrates first pharmacological treatment able to improve cardiac function in stiff-heart syndrome

Transthyretin-related cardiac amyloidosis is a progressive disease characterized by the deposition of amyloid protein fibrils in the heart. Amyloid fibril deposition thickens and stiffens the heart walls, and the disease is also known as stiff-heart syndrome. The accumulation of amyloid fibrils causes heart failure, and patients suffer from fluid retention, fatigue, and arrhythmias. The disease can be caused by genetic mutations or related to aging. Prognosis is poor, and untreated patients survive for an average of just 3 years. Now, the results of a study published in the The New England Journal of Medicine (NEJM) promise to radically alter the prospects of patients with this disease. The study was led by Dr. Pablo Garcia-Pavía, who heads the Inherited Cardiac Diseases Section at Hospital Universitario Puerta de Hierro and is a research scientist at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) and within the Spanish cardiovascular research network (CIBERCV). Coinciding with ...
- Source: drugdu
- 112
- May 22, 2023
CDC

As early signs point to a potential resurgence of mpox cases in the U.S. this summer, the Centers for Disease Control and Prevention (CDC) is rolling out real-world data for Bavarian Nordic’s vaccine and urging at-risk people to take two shots.Bavarian Nordic’s Jynneos, given in two doses, is estimated to be 85.9% effective against mpox, a real-world case-match study conducted in 12 U.S. jurisdictions showed. At one dose, the vaccine was found to be 75.2% effective. The CDC released the results in its new Morbidity and Mortality Weekly Report (MMWR). The report comes as a cluster of 21 mpox cases was reported in Chicago, with several diagnoses among those who were vaccinated raising concerns over Jynneos’ efficacy. Although Jynneos’ efficacy may look similar between the partial and full doses in this study of about 900 people, the CDC is still calling for at-risk people to take two doses because the ...
- Source: drugdu
- 115
- May 22, 2023
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
- 120
- May 21, 2023
Pfizer to raise $31 billion in debt offering to fund Seagen acquisition, SEC filing shows

Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close Friday, according to a prospectus supplement New York-based Pfizer filed with the SEC late Tuesday. The pharma giant’s debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna. Pfizer’s move comes as other corporations including Apple, T-Mobile and Merck rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff. Pfizer’s stock price dropped slightly on Wednesday. The company said it will secure ...
- Source: drugdu
- 129
- May 19, 2023

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