Pfizer asks FDA to authorize COVID-19 pill
Bio Pharma Dive
NOVEMBER 16, 2021
Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death.
Bio Pharma Dive
NOVEMBER 16, 2021
Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death.
World of DTC Marketing
NOVEMBER 16, 2021
SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer? There is no doubt that healthcare is the middle of an evolution not seen in over 30 years.
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Bio Pharma Dive
NOVEMBER 16, 2021
Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech.
Pharma Mirror
NOVEMBER 16, 2021
Rockville, Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients. “This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treat
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
NOVEMBER 16, 2021
A licensing deal with a U.N.-backed patent group could expand supply of Pfizer's experimental drug Paxlovid in lower- and middle-income countries.
pharmaphorum
NOVEMBER 16, 2021
An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example prior to ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 16, 2021
Amazon’s push into the provision of remote healthcare services has been rewarded with a top-tier corporate client – the Hilton hotel chain. The deal – first reported by Reuters – involves the Amazon Care platform, which includes remote, online consultations with clinicians, as well as home visits in some areas. It provides primary and preventive care, ongoing support for chronic conditions, and referrals to secondary and tertiary care.
BioPharma Reporter
NOVEMBER 16, 2021
CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D).
pharmaphorum
NOVEMBER 16, 2021
Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a new AstraZeneca-partnered candidate for heart failure. At the American Heart Association (AHA) congress, the two partners presented results from the phase 2a EPICCURE trial that showed that injecting their AZD8601 candidate directly into the heart muscle of patients undergoing coronary artery bypass graft (CABG) surgery seemed to improve heart functio
Pharma Times
NOVEMBER 16, 2021
The data was obtained by a Freedom of Information request, according to The Independent
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
pharmaphorum
NOVEMBER 16, 2021
Biogen’s chief medical officer Al Sandrock has announced he will retire at the end of the year, ending a 23-year career at the biotech. The architect of many of Biogen’s biggest-selling drugs, Sandrock is bowing out as Biogen is still struggling with the rollout of its controversial new Alzheimer’s disease therapy Aduhelm (aducanumab).
Scienmag
NOVEMBER 16, 2021
Years ago, there was a time that kids from a rural village in South Africa still wanted to swim in the rivers nearby. But when they got out of the water, those with sensitive skins would have the worst rash ever, says Prof Philiswa Nomngongo. She is from the University of Johannesburg’s (UJ) campus in […].
NY Times
NOVEMBER 16, 2021
The company announced a deal that could help significantly expand access to the Covid-19 treatment, but the agreement excludes a number of countries hit hard by the pandemic.
pharmaphorum
NOVEMBER 16, 2021
NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini group company Arvelle Pharma’s Ontozry. The cost-effectiveness agency has backed Ontozry (cenobamate) as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least two prior antiseizure medicines.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
NY Times
NOVEMBER 16, 2021
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the Delta variant.
Triage Cancer
NOVEMBER 16, 2021
Proactively caring for aging parents can present many unique challenges, both logistically and emotionally. This can become even more complex when a parent is diagnosed with cancer or if you are dealing with your own diagnosis while caring for aging parents. The more proactively you begin the care process, the more smoothly and efficiently you will be able to manage potential challenges.
pharmaphorum
NOVEMBER 16, 2021
In the second of a two-part series, Leela Barham argues that whilst international comparisons of uptake are useful, there could be more to gain from looking at more medicines and their uptake in England rather than looking at a small set of medicines and their uptake internationally. This could form a new commitment in the successor to the voluntary scheme learning from experience from measuring uptake on five highest health gain categories of medicines.
Scienmag
NOVEMBER 16, 2021
A study involving UT Southwestern neurology researchers found lower-quality outcomes for Hispanic ischemic stroke patients who receive endovascular thrombectomies than for comparable white and Black patients. Credit: UT Southwestern Medical Center A study involving UT Southwestern neurology researchers found lower-quality outcomes for Hispanic ischemic stroke patients who receive endovascular thrombectomies than for comparable white and Black patients. […].
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
BioSpace
NOVEMBER 16, 2021
While COVID-19 appears to be surging again in the U.S. and Europe, the government is spending billions to acquire antibody and antiviral therapies and edging toward vaccination boosters.
Scienmag
NOVEMBER 16, 2021
LOS ANGELES (November 16, 2021) — The Lundquist Institute’s Investigator Eli Ipp, MD, and a multi-center team of investigators have evaluated the performance of the EyeArt AI system in a study published in JAMA Open Network. Dr. Ipp and his co-investigators found that the accuracy of the EyeArt AI system was high in detecting mtmDR […].
Pharma Times
NOVEMBER 16, 2021
Voluntary license agreement will allow generic versions of pill to be manufactured
Scienmag
NOVEMBER 16, 2021
MUSC Hollings Cancer Center researcher Leonardo Ferreira, Ph.D., well-regarded for his pioneering work with regulatory T-cells, published a paper in Frontiers in Immunology that describes his experience using chimeric antigen receptor (CAR) regulatory T-cells to address the challenge of transplant tolerance. Credit: MUSC Hollings Cancer Center MUSC Hollings Cancer Center researcher Leonardo Ferreira, Ph.D., well-regarded for his pioneering work with regulatory […].
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
BioSpace
NOVEMBER 16, 2021
After 32 years, gene therapy pioneer Guangping Gao, Ph.D., is finally seeing the fruits of the doctoral thesis research he started in 1989.
Scienmag
NOVEMBER 16, 2021
Three Materials Science and Engineering doctoral students—Allison Osmanson, Mohsen Tajedini and Jimmy-Bao Le—earned the Best Student Presenter Award at TECHCON 2021, the flagship technical conference of the Semiconductor Research Corporation (SRC). Credit: UT Arlington Three Materials Science and Engineering doctoral students—Allison Osmanson, Mohsen Tajedini and Jimmy-Bao Le—earned the Best Student Presenter Award at TECHCON 2021, […].
Outsourcing Pharma
NOVEMBER 16, 2021
The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.
Scienmag
NOVEMBER 16, 2021
Nearly 2,500 scientists and engineers will present new research on the physics of fluids at the 74th Annual Meeting of the APS Division of Fluid Dynamics. Credit: Credit: Patrick Hickey / UCLA Nearly 2,500 scientists and engineers will present new research on the physics of fluids at the 74th Annual Meeting of the APS Division of Fluid Dynamics. Held November 21 […].
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
Pharma Times
NOVEMBER 16, 2021
Treatment authorised for use in adults with COVID-19 who are at high-risk of progressing to severe disease
Scienmag
NOVEMBER 16, 2021
Patients with new spinal cord injuries whose blood pressure is maintained within a newly defined range during surgery may stand a better chance of regaining some mobility and functionality – even in patients with the most devastating injuries – according to a new study by researchers at UC San Francisco. Credit: Adam Ferguson, PhD, and […].
NY Times
NOVEMBER 16, 2021
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid, and works differently from the first.
Scienmag
NOVEMBER 16, 2021
The largest survey of pollinator abundance in Wales has found that woodland and hedgerow creation can play a crucial role in action to reverse declines in insects that are essential for crop yield and other wildlife. Credit: None The largest survey of pollinator abundance in Wales has found that woodland and hedgerow creation can play […].
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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