Thu.Dec 22, 2022

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Merck builds out cancer drug pipeline with Kelun-Biotech deal

Bio Pharma Dive

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year.

Drugs 300
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Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

Fentanyl is a powerful opioid (a narcotic analgesic that is at least partly synthetic) that is being trafficked in increasing quantities from Mexico to the US by cartels. The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American.

Drugs 264
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FDA sets decision date for Alvotech’s Humira biosimilar

Bio Pharma Dive

Along with the review deadline, Alvotech also disclosed the FDA had turned back an application for interchangeability as the agency needs to reinspect a manufacturing facility.

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There’s a Worrying Link Between Newest Olympic Sports And Injury Rates

AuroBlog - Aurous Healthcare Clinical Trials blog

Athletes scaled new heights during the 2020 Tokyo Olympics with the addition of seven new sports, including karate and climbing. But while overall injuries remained comparable to previous games, some of the new sports contributed a disproportionately large portion of them. [link] To safeguard athletes’ wellbeing the International Olympic Committee (IOC) audits injuries and illnesses […].

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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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December 22, 2022: HCSRN Extends Early-Bird Registration Deadline for 2023 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2023 annual conference in Denver, Colorado, to January 9. The discounted registration rate will apply through this date. The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials.” The workshop will introduce concepts in the design, conduct, and implementation of pragmati

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Widely prescribed neuropathic pain drugs gabapentin & pregabalin to be under pharmacovigilance scrutiny

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology. PV is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine or vaccine related problem, according […].

Drugs 188

More Trending

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Lilly pays $75M to widen RNA editing deal with ProQR

Bio Pharma Dive

The expanded deal triples the amount of money the biotech could eventually receive from Lilly and adds several more neurological disease drug targets.

RNA 141
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Can dogs smell time? Just ask Donut the dog

NPR Health - Shots

After decades of wondering, an NPR reporter finally figures out how her husband's family dog knew when the school bus would arrive everyday. She did some digging — and now it all makes scents.

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Opinion: Lessons learned from the deadly combination of sepsis and Covid-19

STAT News

Sepsis, a deadly overreaction of the immune system to infection, has befuddled clinicians and researchers for decades. Covid-19 made things worse. The early signs and symptoms of sepsis mimic those of both Covid-19 and influenza: fever, chills, dry cough, shortness of breath, fatigue, muscle or body aches, sore throat, nasal congestion, runny nose, and more.

Research 137
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Henrietta Lacks' hometown will build statue of her to replace Robert E. Lee monument

NPR Health - Shots

A statue of the woman, whose cells were taken without her consent and became integral in several major medical breakthroughs, will be built in Roanoke, Va.

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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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UK, Moderna formalise 10-year vaccines alliance

pharmaphorum

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna. The government said today it has finalised the partnership – agreed in principle earlier this year and estimated to be worth in the region of $1.2 billion – although it is not revealing the financial details, as these are “commercially sensitive.” The overar

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U.S. life expectancy falls for second straight year as drug overdose and Covid deaths take toll

STAT News

Life expectancy for Americans fell for the second straight year in 2021, largely driven by increases in deaths from Covid-19 and drug overdoses, according to new data from the Centers for Disease Control and Prevention. A baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996.

Drugs 119
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Pfizer, Sanofi settle first California Zantac case slated for trial: report

Fierce Pharma

Pfizer, Sanofi settle first California Zantac case slated for trial: report. zbecker. Thu, 12/22/2022 - 12:38.

Trials 138
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Pandemic response gets a permanent new home at the White House

STAT News

WASHINGTON — The era of the rotating cast of public health czars at the White House may finally be over. Presidents for decades have brought fresh faces to the White House to coordinate federal responses to threats such as Covid-19, mpox, Ebola, AIDS, and the bird flu.

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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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When elders can't hear words at a noisy holiday gathering, too many brain cells may be firing at once

Medical Xpress

Looking for answers about how the brain works amid age-related hearing loss, Johns Hopkins Medicine researchers say they have found that old mice were less capable than young mice of "turning off" certain actively firing brain cells in the midst of ambient noise. The result, they say, creates a "fuzzy" sound stage that makes it difficult for the brain to focus on one type of sound—such as spoken words—and filter out surrounding "noise.".

Medicine 105
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After nine months, an update on NIH’s long Covid research

STAT News

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up  here  to receive it in your inbox. Pandemic response gets a home at the White House. The White House has relied on a rotating cast of temporary czars to coordinate responses to public health threats from Covid-19, to mpox, to AIDS, to the bird flu.

Packaging 111
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Japanese drugmakers make greener packaging pledge

pharmaphorum

Four Japanese drugmakers – Astellas, Eisai, Daiichi Sankyo, and Takeda – have joined forces in a partnership intended to reduce the environmental impact of pharmaceutical packaging. The companies say they will promote the use of greener packaging for their products by sharing knowledge on technologies that can reduce their environmental impact , including blister packs made of biomass- rather than petroleum-derived plastics and more compact packaging, as well as recycled and recyclable materials

Packaging 105
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Under new rules, methadone clinics can offer more take-home doses. Will they?

STAT News

Danielle Russell is, as she says, a “poster child” for methadone. For more than a decade, the medication — one of the most effective treatments for opioid addiction — has helped her move past the heroin she used to use. She finished a series of degrees, and is now a Ph.D. student in justice studies at Arizona State University.

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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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High-energy X-rays leave a trace of destruction in bone collagen

Medical Xpress

A team of medical researchers at Charité-Universitätsmedizin has analyzed damage by focused high energetic X-rays in bone samples from fish and mammals at BESSY II. With a combination of microscopy techniques, the scientists were able to document the destruction of collagen fibers induced by electrons emitted from the mineral crystals. X-ray methods might impact bone samples when measured for a long time, the researchers conclude.

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NORD’s Dr. Neilan Discusses Next Steps for Rare Disease Clinical Trials

XTalks

The National Organization for Rare Disorders ( NORD ) is a patient advocacy organization that is devoted to people with rare diseases and the various organizations that help them. NORD, along with its more than 330 member patient organizations, is “committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services.”.

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Cognitive scientists develop new model explaining difficulty in language comprehension

Medical Xpress

Cognitive scientists have long sought to understand what makes some sentences more difficult to comprehend than others. Any account of language comprehension, researchers believe, would benefit from understanding difficulties in comprehension.

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STAT+: Backed by a longtime mental health leader, a new startup aims to build support for serious mental illness

STAT News

The number of startups focused on mental health has surged in the wake of the pandemic and a growing mental health crisis. They want to help people to meditate on their phones, or prescribe drugs that can be delivered right to their doors. But few focus on the most vulnerable patients, people with serious mental illness, in the real world. This month, a for-profit startup co-founded by former National Institute of Mental Health leader Thomas Insel quietly launched with $29 million in funding to

Drugs 98
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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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Treating COVID-19 infection with molnupiravir can lead to quicker recovery at home

Medical Xpress

Molnupiravir (taken as an 800mg dose twice daily for five days) does not reduce hospital admissions or deaths in vaccinated adults with COVID-19 infection who are at higher risk of mortality, according to the results of a randomized controlled trial, published in The Lancet journal. However, the patients treated at home with molnupiravir recovered quicker compared to the control group.

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STAT+: Apple Watch hit with import ban, but ruling remains suspended as AliveCor patent battle plays out

STAT News

In the latest twist in a battle between Apple and medical device company AliveCor, the U.S. International Trade Commission issued a ban preventing Apple from importing all watches that use the hotly contested heart monitoring technology, but said the enforcement of that order will be suspended until appeals over the patents in question have played out.

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Cystic fibrosis drug could help treat pneumonia

Medical Xpress

Pathogens such as SARS-CoV-2 and pneumococcus can cause severe pneumonia. If the airways then fill with fluid, the patient risks developing acute respiratory distress syndrome. Researchers at Charité—Universitätsmedizin Berlin have now discovered the molecular mechanisms that trigger fluid accumulation in the lungs.

Drugs 98
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STAT+: Pharmalittle: Merck pays Chinese biotech $175 million for cancer drugs; who will make a gene therapy for very sick kids?

STAT News

Good morning everyone! Matthew Herper is here, filling in for Pharmalot, who is taking a well-deserved break, which means that today there’s English Breakfast tea instead of flavored coffee and two cozy cats instead of the usual mascot. What doesn’t change is that we’ve got the usual roundup of pharma news for you to read. We hope your holiday preparations are going swimmingly and that your work is starting to wrap up.

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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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Study discovers novel therapeutic target to advance the treatment of diabetic eye diseases

Medical Xpress

A recent study discovered a novel therapeutic target named ADAM10 that could be used to treat patients with Diabetic Retinopathy (DR), a condition that leads to blindness induced by prolonged diabetes. Abnormal blood vessel formation in the eyes of diabetic patients is a common phenomenon for DR, which could ultimately result in vision loss.

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Eisai and Biogen’s latest Alzheimer’s drug needs to be cheaper than the last one, analysts say

STAT News

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday. The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 pe

Drugs 98
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Economist Impact: World Cancer Series – pharmaphorum in attendance, day one (part iv)

pharmaphorum

To conclude pharmaphorum’s look back at day one of The Economist’s 8th Annual World Cancer Series congress in Brussels, Belgium, in November – where the foci were “innovation, equity, and excellence” – after the panel, ‘The future of European cancer control in a time of crisis’, came The Economist’s health policy editor Natasha Loder’s interview with Dame Kate Bingham, managing partner at SV Health Investors and former chair of the UK Government’s Vaccine Taskforce during the pandemic.

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2022 in review, CEO indictments, & the year ahead

STAT News

When does optimism become criminal? Why can’t biotech find its way back? And what’s going to happen in 2023? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We look back on the biggest biotech stories of 2022 and how, despite some meaningful advances in Alzheimer’s disease and gene therapy, the industry seems stuck in a sentiment rut.

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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.