Tue.Sep 13, 2022

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

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Can biotech IPOs bounce back? Third Harmonic to test investor appetite with planned offering

Bio Pharma Dive

The startup is the first young drugmaker in more than four months to seek an IPO of at least $100 million, a once common occurrence that's become rare following this year's sector-wide correction.

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ESMO 2022: neoadjuvant or adjuvant immunotherapy for locally advanced cancers?

Pharmaceutical Technology

The advent of immune checkpoint inhibition has arguably been the greatest breakthrough for the treatment of metastatic solid tumours, with durable complete responses observed across multiple cancer types. With success in the metastatic setting, pharma companies, researchers and physicians have invested heavily in exploring the use of immune checkpoint inhibitors (ICIs) for the treatment of locally advanced disease, hoping to increase response rates and prevent disease progression.

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BioMarin reports cancer case in hemophilia gene therapy trial

Bio Pharma Dive

The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.

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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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Novartis to make $300m investment in next-generation biotherapeutics

Pharmaceutical Technology

Nova r tis has announced plans to make investments worth $300m in next-generation biotherapeutics and to strengthen its capacity and expertise in the initial technical development of biologics. For this purpose, the company will create a completely integrated scientific environment. The multi-year investment, covering the development of drug substances as well as drug products, will be implemented across the current locations of the company in Switzerland, Austria and Slovenia.

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Akero shares soar as NASH drug succeeds in mid-stage trial

Bio Pharma Dive

The biotech’s experimental medicine meaningfully improved multiple signs and symptoms of patients with NASH, a common liver disease that's proven a tough target for several drugmakers.

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Rubius, a once high-flying biotech startup, lays off much of its staff

Bio Pharma Dive

The biotech will reduce staff by 75% and end development of two drugs, the latest setback for a company that was worth nearly $2 billion when it went public in 2018.

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AmerisourceBergen agrees to acquire PharmaLex for $1.29bn

Pharmaceutical Technology

AmerisourceBergen has entered a definitive agreement for the acquisition of PharmaLex from Auctus Capital Partners in a deal worth $1.29bn (€1.28bn) in cash, subject to specific adjustments. The acquisition will expand the international solutions portfolio of AmerisourceBergen aiding in advancing its position as a preferred partner for biopharmaceutical manufacturers.

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STAT+: Akero treatment for NASH reduces liver scarring, achieves goals of mid-stage study

STAT News

Akero Therapeutics said Tuesday that an experimental medicine improved liver scarring at twice the rate of a placebo without worsening other symptoms — achieving the main goal of a mid-stage clinical trial involving patients with the fatty liver disease known as NASH. If the encouraging study results are confirmed in later Phase 3 clinical trials, the Akero drug, called efruxifermin, could become an effective treatment for a chronic disease that has grown into one of the leading causes of

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September 13, 2022: IMPACT Collaboratory Extends Deadline for Demonstration Project Letters of Intent

Rethinking Clinical Trials

The deadline to submit letters of intent for the NIA IMPACT Collaboratory’s Demonstration Projects Program has been extended to September 30, 2022. This summer, the IMPACT Collaboratory announced a request for applications for its Demonstration Projects Program. This funding mechanism supports large-scale pragmatic clinical trials embedded in healthcare systems to test the effectiveness of nonpharmacological interventions for people living with Alzheimer disease and related dementias and

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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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Opinion: Medicare needs to update its wheelchair coverage for the 21st century

STAT News

Both of us have spent much of our lives in wheelchairs. But not just any wheelchairs. Ours are equipped with power seat elevation and standing technologies individually configured to meet our needs. At the push of a button, our wheelchairs can elevate us to eye level with a nondisabled person or position us in a “standing” posture. We can complete everyday tasks like going to the bathroom or stocking kitchen cabinets that are nearly impossible for those who spend all or nearly all

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The economics behind 'quiet quitting' — and what we should call it instead

NPR Health - Shots

Is "quiet quitting" about being lazy or setting healthy boundaries? Is it even real? We dig into the data and ask workers themselves about what it means to them.

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Opinion: Vaccine guarantees can help prevent the resurgence of polio

STAT News

The first case of polio in the U.S. in a decade has triggered intense debate and unease. On Friday, New York Gov. Kathy Hochul declared a disaster after polio virus was detected in the wastewater of a third county in the state. Health officials are advocating for improving domestic vaccination rates to prevent a resurgence of polio, as they should. But this is only part of the solution.

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Biden touts his 'cancer moonshot' on the anniversary of JFK's 'man on the moon' speech

NPR Health - Shots

Biden announced many of what he calls "cancer moonshot" goals in February. On Monday he laid out some updates in a speech that marked 60 years since Kennedy gave his iconic moonshot speech.

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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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Opinion: Health care needs a Black Friday sale: the case for legalizing discounts on medical services

STAT News

The best time to buy a car is at model year-end sales, and Black Friday deals can’t be beat for major appliances. Ever wonder why you don’t see a President’s Day sale on colonoscopies? Or ads for buy-one-get-one free knee replacements? In most instances, offering patients a discount on health care services would be considered an improper patient inducement under the federal Civil Monetary Penalties Law and the Anti-Kickback Statute.

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Federal Officials Report of HelloFresh E. Coli Outbreak

XTalks

The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) reported a public health alert due to concerns that the ground beef in some HelloFresh meal kits may be associated with E. Coli illness. While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase.

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STAT+: Pharmalittle: Biden picks biotech exec to lead new biomedical research agency; FDA to hold meeting for OTC birth control pill

STAT News

Hello, everyone, and how are you today? The skies over the Pharmalot campus remain gloomy this morning, but our spirits are sunny, nonetheless. After all, as the Morning Mayor liked to say: Every new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will get busy gathering interesting items for you to peruse. So time to get started.

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ONWARD reports positive results from a pivotal spinal cord injury study

Pharma Times

Up-LIFT research achieves primary endpoint with improvement in arm and hand function

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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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An exclusive chat with Google’s Ivor Horn and the details on Verily’s $1 billion round

STAT News

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Bayer taps Clariness to build patient insights into clinical trial review process

Outsourcing Pharma

Bayer Pharma has enlisted Clariness to support its new study review process by providing pre-clinical trial patient insights and post-trial feedback.

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Thousands of nurses in Minnesota go on strike over better working conditions

NPR Health - Shots

NPR's Juana Summers speaks with Chris Rubesch, first vice president of the Minnesota Nurses Association, about why thousands of nurses are on strike for better work conditions.

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WHO calls for greater investment into research for millions living with long COVID

Pharma Times

Modelling indicates a 307% increase in cases identified between 2020 and 2021

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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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Idaho's extensive abortion ban is impacting neighboring Washington

NPR Health - Shots

Idaho's near-total abortion ban is one of the most austere in the country. It's already having a ripple effect in neighboring Washington state. Some Idaho lawmakers are trying to push it even further.

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Verily raises $1bn to push ahead with precision health plans

pharmaphorum

It’s all change at Alphabet’s life sciences business Verily, with a $1 billion funding round and a shake-up of its senior leadership, including a new chief executive and executive chairman, who will have to decide how to spend the new money. Verily’s Andrew Conrad. Company founder Andy Conrad is stepping down as CEO and moving to the executive chairman position, while current president Stephen Gillett is being promoted to the CEO role two years after joining the company from Go

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The Inflation Reduction Act: Three Unintended Consequences for Biosimilars, Health Plans, Providers, and Pharmacies

Drug Channels

By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. 117-169). Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation. These include disruption to the now-booming biosimilar market, the prospects of physician/hospital vertical integration that will raise commercial healthcare costs and expand 340B, and the need for complex new processes to admini

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Nurses in Minnesota are in the middle of a 3-day strike

NPR Health - Shots

Thousands of nurses in Minnesota walked off the job Monday to protest being understaffed and overworked. The nurses are demanding among other things higher wages.

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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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Honoring Deaf Awareness Month

ACRP blog

ACRP spoke with Meribeth Germino, Senior Leadership and Team Performance Coach for Product Development, Genentech, about the importance of Deaf Awareness Month and how clinical researchers can more effectively work with this underserved population. The post Honoring Deaf Awareness Month appeared first on ACRP.

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Latest eBook – Make the switch to label-free interaction analysis

Drug Discovery World

The latest Creoptix eBook reveals the challenges presented by conventional label-based bioassays and explores how label-free interaction analysis can deliver a world of insight. Conventional bioassays rely on enzyme or fluorescent labels to detect biomolecular interactions. These come with challenges that lead to skewed and inaccurate results. In this eBook, learn how label-free interaction techniques drive: Faster analysis – fewer sample preparation steps.

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Today’s Clinical Trials: Do Print Materials Still Pack a Punch?

Imperical Blog

Even in this digital age, printed clinical trial materials remain popular and important tools for keeping sites and patients engaged. Clinical study sites rely on printed materials to gain local interest, and popular examples include: Posters Flyers Brochures Fact sheets These printed tools are designed… The post Today’s Clinical Trials: Do Print Materials Still Pack a Punch?

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Curavit partners with ixlayer for ‘frictionless’ patient experience in DCT

Outsourcing Pharma

The virtual contract research organization (VCRO) Curavit Clinical Research has entered a long-term partnership with ixlayer. The partnership ushers in convenience for patients in Curavitâs trials.

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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.