Tue.Nov 16, 2021

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Pfizer asks FDA to authorize COVID-19 pill

Bio Pharma Dive

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.

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Omnichannel marketing is the answer but what’s the question?

World of DTC Marketing

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.

Marketing 253
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Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit

Bio Pharma Dive

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.

Scientist 278
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Emmes and MedGenome Launch Genomics Strategic Partnership Focused on Advancing Rare Disease Research

Pharma Mirror

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

Genome 130
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Pfizer will allow generic drugmakers to produce promising COVID-19 pill

Bio Pharma Dive

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.

Licensing 269
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FDA clears GE Healthcare AI algorithm for patient intubation

pharmaphorum

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.

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Boost for Amazon’s telehealth business, as Hilton signs up

pharmaphorum

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.

Pharmacy 133
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Gene-edited cell replacement therapy for diabetes set to enter the clinic

BioPharma Reporter

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).

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AZ, Moderna say mRNA drug is promising in heart failure

pharmaphorum

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

Drugs 130
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Report: UK disposed of 600,000 AZ vaccine doses after they passed expiry date

Pharma Times

The data was obtained by a Freedom of Information request, according to The Independent

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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In shock move, Biogen chief medical officer Al Sandrock will stand down

pharmaphorum

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).

Drugs 105
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Why drinking water needs monitoring for HIV drugs

Scienmag

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 […].

Drugs 99
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Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries

NY Times

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.

Drugs 98
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Drug-resistant epilepsy drug Ontozry backed by NICE

pharmaphorum

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.

Drugs 98
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The New Age of Decentralized Clinical Trials

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.

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U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People

NY Times

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.

Drugs 98
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Proactively Caring for Aging Parents

Triage Cancer

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.

Doctors 96
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Are we measuring what matters most on uptake to medicines in England?

pharmaphorum

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.

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UTSW study finds Hispanic people receive lower-quality thrombectomies than white people

Scienmag

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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Accelerating Clinical Supply Through Integrated Drug Development

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.

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US Spends $1 Billion on GSK-Vir Antibody; Pfizer Requests Paxlovid Approval

BioSpace

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.

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Lundquist Institute investigator is lead author on a JAMA open network publication that positively evaluates EyeArt AI system to prevent diabetic vision loss

Scienmag

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 […].

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Pfizer signs deal to allow expanded use of COVID-19 treatment

Pharma Times

Voluntary license agreement will allow generic versions of pill to be manufactured

Licensing 126
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New immunology researcher probes regulatory T-cell biology to develop living drugs

Scienmag

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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How Machine Learning Drives Clinical Trial Efficiency

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.

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AAV Pioneer Guangping Gao Created Hope for Canavan Disease Cure

BioSpace

After 32 years, gene therapy pioneer Guangping Gao, Ph.D., is finally seeing the fruits of the doctoral thesis research he started in 1989.

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Materials Science and Engineering students earn three Presenter Awards at TECHCON

Scienmag

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, […].

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Pfizer inks COVID-19 treatment licensing agreement with MPP

Outsourcing Pharma

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.

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Press tips for the 74th Annual Meeting of the APS Division of Fluid Dynamics

Scienmag

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 New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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EC approves Celltrion’s COVID-19 mAb Regkirona

Pharma Times

Treatment authorised for use in adults with COVID-19 who are at high-risk of progressing to severe disease

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For new patients with paralysis, tighter blood pressure management may lead to more mobility

Scienmag

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 […].

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Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People

NY Times

The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid, and works differently from the first.

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Woodland and hedgerow creation can play crucial role in action to reverse declines in pollinators

Scienmag

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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.