Sat.Jan 28, 2023 - Fri.Feb 03, 2023

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How are digital biomarkers reshaping Parkinson’s disease research?

Bio Pharma Dive

Your Parkinson’s disease trials need better data. Hear how digital biomarkers change the game.

Research 246
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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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The possible effects of cinnamon on memory and learning

Medical Xpress

Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.

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Opinion: Disruptive science is leaping forward, not limping along

STAT News

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

Scientist 145
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). Under the terms of the deal, uniQure will obtain the worldwide rights to develop and market the clinical stage gene therapy, APB-102. uniQure stated that the license of APB-102 further strengthens its gene therapies pipeline developed for the treatment of neurological disorders as well

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STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT News

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

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FDA approves cancer drugs from Lilly, Menarini

Bio Pharma Dive

The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.

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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

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This winter's U.S. COVID surge is fading fast, likely thanks to a 'wall' of immunity

NPR Health - Shots

The main reason the surge is ebbing now, pandemic experts suspect, is the significant immunity many people in the U.S. have acquired from prior infections and COVID vaccinations many received.

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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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These blood-clot catching devices have been controversial for years. Why are doctors still relying on them?

STAT News

Inferior vena cava filters are supposed to save lives. The spider-like devices catch blood clots before they can travel up to the lung and cause deadly pulmonary embolisms. But for over a decade, these devices have been dogged by questions about how well they work and the serious complications they can cause for patients. The latest data make clear they’re still causing problems: Researchers examined a Food and Drug Administration database and found that adverse event reports related to t

Doctors 137
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Biotech CFOs eye research cuts, partnerships amid sector retrenchment: report

Bio Pharma Dive

The report, a yearly poll of 100 financing executives by accounting and consulting firm BDO, revealed the many levers young drugmakers are pulling to conserve cash.

Research 340
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Pfizer reports 30% operational growth in full-year 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 30% operational growth in revenues to $100.3bn in full-year 2022 compared with $81.2bn reported last year. The revenues grew 2% operationally excluding Paxlovid and Comirnaty’s contributions. In the fourth quarter (Q4) of 2022, they increased 13% operationally to $24.3bn compared to $23.8bn in the same quarter last year. On an operational basis, the revenues rose by 5%, omitting contributions from Paxlovid and Comirnaty.

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A baby spent 36 days at an in-network hospital. Why did her parents get a huge bill?

NPR Health - Shots

A family had more than $12,000 in medical bills they couldn't explain after their baby was delivered early. It turns out the doctors who cared for her worked at a different, out-of-network hospital.

Doctors 136
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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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Survey: A majority of Americans support banning all tobacco products

STAT News

WASHINGTON — A majority of Americans support banning all tobacco products, according to a new poll published by researchers at the Centers for Disease Control and Prevention. The survey , which was published Thursday in the peer-reviewed journal Preventing Chronic Disease, asked 6,455 people nationwide: “To what extent would you support a policy to prohibit the sale of all tobacco products?

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Magenta to explore sale, merger after study setback

Bio Pharma Dive

The biotech recently stopped a trial of its experimental conditioning regimen over safety concerns. Now it’s halting further development work as it undertakes a strategic review.

Sales 317
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Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

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Common eye infection antibiotic tablet may clear up treatment-resistant sex bug

Medical Xpress

An oral antibiotic tablet used to treat common eye infections may prove an effective medicine for a sexually transmitted bug that has become resistant to usual recommended treatment, suggest doctors in the journal Sexually Transmitted Infections.

Doctors 132
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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MRI scans reveal disparate impact of poverty and other ‘toxic stress’ on brains of Black children

STAT News

Stressful experiences during early childhood — particularly economic strife — appear to act as a toxic stressor that can alter regions of the brain tied to the processing of stress and trauma, according to a new study published Wednesday. The researchers found that Black children were impacted more than white children, largely because of the higher amounts of poverty and adversity they face.

Research 131
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Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly.

Marketing 360
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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.

Sales 246
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Junk food companies say they're trying to do good. A new book raises doubts

NPR Health - Shots

As the marketing of soda and fast food ramps up around the world, the companies involved forge partnerships to help the poor. The new book 'Junk Food Politics ' casts a critical eye at their efforts.

Marketing 130
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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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STAT+: Biden administration floats major 2024 pay cut for Medicare Advantage plans

STAT News

Medicare Advantage insurers could face an average 2.3% cut to baseline payments in 2024, the Biden administration said Wednesday. If the proposal stands, it would be a net cut of more than $3 billion to the industry. The major reason behind the proposed pay cut: Medicare officials want to update data and coding systems that are used to explain the health conditions of an insurance company’s enrollees.

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COVID-19 vaccine maker Medicago to close down

Bio Pharma Dive

The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment.

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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

The field of genomic medicine has reached a true turning point. With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting.

Genome 244
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SNAP recipients will lose their pandemic boost and may face other reductions by March

NPR Health - Shots

Congress ended the temporary benefit meant to help low-income households with pandemic-era hardships. A huge increase in Social Security benefits may mean some households see further SNAP reductions.

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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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Opinion: Promises — and pitfalls — of ChatGPT-assisted medicine

STAT News

Not long after the artificial intelligence company OpenAI released its ChatGPT chatbot, the application went viral. Five days after its release, it had garnered 1 million users. Since then, it has been called world-changing , a tipping point for artificial intelligence, and the beginning of a new technological revolution. Like others, we began exploring potential medical applications for ChatGPT, which was trained on more than 570 gigabytes of online textual data, extracted from sources like boo

Medicine 130
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Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline

Bio Pharma Dive

Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions.

Drugs 293
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Pharma sector reels as UK Government doubles VPAS payback rate on NHS drugs

Pharmaceutical Technology

The UK government’s decision to set an unprecedented payback rate of 26.5% on National Health Service (NHS) sales of branded medicines in 2023, almost double that of the previous year, has sent shock waves through the pharma industry. This payback rate applies to corporate members of the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), a five-year scheme initiated in 2019, which returns a proportion of funds to the NHS based on the sales of branded prescription medicines (innova

Branding 243
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Muslim-American opinions on abortion are complex. What does Islam actually say?

NPR Health - Shots

Since the Supreme Court ended the constitutional right to an abortion, many Muslims Americans have been turning to their faith to try to figure out: What does Islam say about the issue?

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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.