Sat.Jun 11, 2022 - Fri.Jun 17, 2022

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Pfizer study results show Paxlovid benefit less clear in lower-risk patients

Bio Pharma Dive

A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.

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The importance in health insurance in retaining employees

World of DTC Marketing

Sixty percent of employees in a recent survey reported experiencing healthcare cost increases that outpaced inflation in the past three years, and 63 percent expect that trend to continue, signaling potential cost challenges in the future. Right now, annual raises are being neutralized by increasing healthcare insurance premiums. If pharma wants to retain people, they may have to develop a solution to lower healthcare insurance premiums.

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. In case you missed it, you can watch the full webinar, here , or check out the top five things you missed: 1.

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F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients

NY Times

The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Bio Pharma Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

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US life expectancy continues historical decline.

World of DTC Marketing

According to a new report , life expectancy in the United States took another hit in 2021, furthering a dramatic decline from 2020 that was the largest since World War II. US life expectancy decreased from 78.86 years in 2019 to 76.99 years in 2020 and 76.60 years in 2021, a net loss of 2.26 years. In contrast, peer countries averaged a smaller decrease in life expectancy between 2019 and 2020 (0.57 years) and a 0.28-year increase between 2020 and 2021, widening the gap in life expectancy betw

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More Trending

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Jazz and Redx in milestone inhibitor agreement

Pharma Times

Jazz Pharmaceuticals and Redx announce that pan-RAF inhibitor will enter clinical development

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Pharma under the microscope as FTC considers new ways to review acquisitions

Bio Pharma Dive

At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.

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Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

pharmaphorum

The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease. The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another blow to the

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Opioid use disorder: Flexible treatment at home proves effective

Scienmag

Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September 2021? Or that more than 350,000 people who used drugs containing opioids to relieve their pain did so problematically? Credit: CHUM Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September […].

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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NICE recommends Eli Lilly’s breast cancer therapy

Pharma Times

Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence

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Roche Alzheimer's study fails in another setback to a long-tested hypothesis

Bio Pharma Dive

The failure is an upset not only to Roche, but also a blow to the wider Alzheimer’s research field, which has for years kept focus on a protein called beta amyloid.

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Moderna Plans Trial Testing COVID-19 Vaccine in Youngest Babies

BioSpace

Moderna's study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.

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Six months after authorization, what do we know about Paxlovid?

pharmaphorum

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” . At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug.

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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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Novartis receives vital licence for Scemblix

Pharma Times

Therapy represents the first STAMP inhibitor for patients with chronic myeloid leukaemia

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Vertex, CRISPR strengthen case for pioneering gene-editing treatment

Bio Pharma Dive

Positive data from 75 patients with either sickle cell disease or beta thalassemia keep the companies’ therapy on track to become the first CRISPR-based treatment submitted to drug regulators, possibly by the end of the year.

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Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says

NY Times

Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.

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Data-Led Digital KOL Engagement

pharmaphorum

When creating engagement plans for individual Digital Key Opinion Leaders (DOLs), it’s best to look at a range of data-led metrics about each DOL to fine tune the engagement and maximise benefit for all parties. The simplest, and often easiest metrics to obtain, relate to the activity characteristics of the Digital KOL. In Twitter for example, this may equate to the DOL’s activity levels, follower numbers, and so on.

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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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Merck and Mulliken Center collaborate for machine learning project

Pharma Times

The three-year project will focus on molecular representations and computational tools

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With biotech in retreat, Third Rock raises $1B for life sciences investing

Bio Pharma Dive

The fund, Third Rock’s sixth, comes amid a significant downturn in the biotech stock market, which has raised questions about the viability of young drug startups.

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Pandemic highlights need for supply chain visibility, partnerships

Outsourcing Pharma

During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.

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2nd NSCLC Drug Development Summit

pharmaphorum

The 2nd NSCLC Drug Development Summit returns for its second year to unite biopharma and academic leaders during an exciting era of personalized medicine. The industry is uniting to address mechanisms of drug resistance, spearhead progress in molecular subtyping and define practice-changing drug sequencing and combinations for the largest solid tumor indication, NSCLC.

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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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Nordic Bioscience and Roche strengthen collaboration

Pharma Times

The companies will focus on the development of biomarkers for chronic diseases

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What Biotech and Pharma need to consider about decentralized trials

Bio Pharma Dive

The pandemic motivated sponsors to reimagine decentralized trials and realize the benefits these models deliver.

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Co-existing mangrove-coral habitats have a new global classification system

Scienmag

On any given day between 2016 and 2019, Heather Stewart could be found snorkeling in between mangroves in the Bocas del Toro archipelago along Panama’s Caribbean coast. For years she visited these forests at the interface between land and sea, trying to understand what drove corals to grow inside them. Corals and mangroves often grow […].

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Why diverse clinical trials matter: the pharmaphorum podcast

pharmaphorum

In this episode of the pharmaphorum podcast, editor in chief Jonah Comstock welcomes Dr. Jennifer Jones-McMeans, divisional vice president for global affairs for Abbott’s vascular business to discuss diversity and equity in clinical trials. They discuss the nitty-gritty of clinical trial diversity – why it’s been so hard to achieve, why it’s important, and how to overcome the specific barriers to inclusion for different underrepresented communities.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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First patient dosed in Scancell’s clinical trial for multiple cancers

Pharma Times

First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer and renal cancer

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FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

Bio Pharma Dive

The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch.

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New Nano-Sensor Can Detect Pesticides on Produce in Minutes

XTalks

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. A study published in the journal Advanced Science outlines how the nano-sensors use flame-sprayed nanoparticles to increase the signal of chemicals. While still at an early stage, the researchers hope these nano-sensors could help uncover pesticides before consumption.

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MorphoSys slims down, narrowing its focus to cancer

pharmaphorum

MorphoSys seemingly inexorable shift into an oncology pure-play has continued with an out-licensing deal for two programmes in the kidney disease and immunology categories to China’s HIBio. The German biotech is handing over rights to CD38-targeted antibody felzartamab for two forms of glomerulonephritis and MOR210, an anti-C5aR1 antibody for autoimmune disorders and some forms of cancer, which are both currently in early-stage clinical testing.

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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.