Pharmaceutical Technology

JANUARY 13, 2023

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.

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Bio Pharma Dive

JANUARY 13, 2023

The discussions come months after two patients died from acute liver injury following treatment with the spinal muscular atrophy therapy.

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Deltaclinical

JANUARY 13, 2023

Home visits for clinical trials are becoming increasingly popular, as they offer a number of distinct benefits for both the patient and the provider. At Delta Healthcare Consulting, we understand how valuable home visits can be in providing high quality care to patients. A few key benefits of these visits include a more convenient experience, motivated participants, and higher retention rates.

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Clinical Trials Clinical Trials Trials Allergies 130

Bio Pharma Dive

JANUARY 13, 2023

The approval could help Rybelsus compete with oral drugs marketed by Eli Lilly, Merck & Co. and others.

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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

Clinical Research

Deltaclinical

JANUARY 13, 2023

Home visits for clinical trials are becoming increasingly popular, as they offer a number of distinct benefits for both the patient and the provider. At Delta Healthcare Consulting, we understand how valuable home visits can be in providing high quality care to patients. A few key benefits of these visits include a more convenient experience, motivated participants, and higher retention rates.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Allergies 130

Bio Pharma Dive

JANUARY 13, 2023

The state filed suit Thursday against pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx, alleging they worked with drugmakers to drive up the price of insulin.

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Insulin Pharmacy 141

STAT News

JANUARY 13, 2023

Oscar Health has excelled at one thing in particular since its inception a decade ago: burning cash. The health insurance company did not plan to be profitable immediately. It was staking its future on the new Affordable Care Act marketplaces and had to grow quickly to compete with larger insurance carriers. Oscar organized its health insurance product through an app, promoted virtual care, advertised on New York subways, and then low-balled prices in certain markets to attract young, healthy pe

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Production Marketing 144

Deltaclinical

JANUARY 13, 2023

Home visits for clinical trials are becoming increasingly popular, as they offer a number of distinct benefits for both the patient and the provider. At Delta Healthcare Consulting, we understand how valuable home visits can be in providing high quality care to patients. A few key benefits of these visits include a more convenient experience, motivated participants, and higher retention rates.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Allergies 130

STAT News

JANUARY 13, 2023

SAN FRANCISCO — Ginkgo Bioworks CEO Jason Kelly is here trying to convince the world’s largest drugmakers that yes, really, he actually can in fact help you. Kelly’s powers of persuasion, so potent for so long, have often come up short since Ginkgo went public in 2021. The company that raised $1.6 billion privately on the promise of engineering cells to make everyday products like perfumes and synthetic burgers — even one day an iPhone — has sunk like a rock on

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Engineer Production Marketing 111

pharmaphorum

JANUARY 13, 2023

The ‘big three’ insulin producers Novo Nordisk, Eli Lilly, and Sanofi are being sued by the state of California for allegedly working together to set artificially inflated prices for their products. The lawsuit also takes aim at the three largest pharmacy benefit managers (PBMs) in the US – CVS Caremark, Express Scripts, and OptumRx – which are accused of adopting a system of rebates that incentivise manufacturers to raise list prices for insulin and promote higher-priced products.

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

Clinical Trials

STAT News

JANUARY 13, 2023

WASHINGTON — David Kessler, the D.C. veteran who guided government dispatches of millions of Covid-19 vaccines and treatments, is exiting the Biden administration this month. His departure comes as the White House winds down a nearly three-year public health emergency amid stabilizing case trends, but also continues to grapple with depleted coronavirus response funds and public fatigue around the virus.

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pharmaphorum

JANUARY 13, 2023

Editor-in-chief Jonah Comstock lays out a few of the most potent threads he heard in the conference centres, hotel rooms, and rain-soaked Lyfts of San Francisco. After my customary cross-country redeye, I’ve officially traded the relentless rain of San Francisco for the gentle snowfall of my native Boston. And as I look out the window at that snow, my travel-addled brain can’t help but see it as a metaphor for pharma in 2023: a crisp white, wide canvas laden with possibilities, but also one that

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STAT News

JANUARY 13, 2023

Access to treatment for addiction has long plagued U.S. health systems. Why? Two reasons: It is expensive, and the long-term value of addiction treatment is often disregarded by insurance companies and other payers. Its dirty little secret is that access to treatments that work are available to the few who can pay for it — as I once needed to do — while millions of Americans get substandard treatment or none at all.

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Pharma Times

JANUARY 13, 2023

Company becomes the latest member of the ABPI and galvanises the company’s UK connections

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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.

Clinical Supply

STAT News

JANUARY 13, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to promenade extensively with the official mascot, catch up on our reading, and maybe hold a listening party with Mrs. Pharmalot (for now, the rotation will start with this and this ).

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NPR Health - Shots

JANUARY 13, 2023

It's the last weekend for Obamacare open enrollment, and nearly 16 million Americans have signed up for a health insurance plan.

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STAT News

JANUARY 13, 2023

Editor’s note: A live stream of the event will be embedded below at 1 p.m. ET. Relive the return to an in-person J.P. Morgan Healthcare Conference with the STAT reporters who attended. Get a full rundown of the deals, data, and scuttlebutt and come away with the ideas and water-cooler chatter you need for next week.

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Pharma Times

JANUARY 13, 2023

Green light for new asthma pen which offers self-administration option across the EU

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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.

Clinical Trials

STAT News

JANUARY 13, 2023

Marianne De Backer’s iPhone calendar is a solid block of green. De Backer, the head of strategy and business development at Bayer, has so many meetings on her schedule that there’s no telling where one ends and another begins. She hasn’t moved for much of the day from her spot in a Hilton conference room in San Francisco, decorated in shades of tan.

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Fierce Pharma

JANUARY 13, 2023

AmerisourceBergen Expands Global Footprint and Commercialization Solutions with Acquisition of PharmaLex. jpiatt. Fri, 01/13/2023 - 10:18.

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STAT News

JANUARY 13, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Drug Channels

JANUARY 13, 2023

Today’s guest post comes from Clay Courville, Chief Product Officer at CoverMyMeds. Clay discusses the ongoing problem of medication errors. He describes CoverMyMeds’ provider alerts solution, which is designed to minimize medication errors. Click here to learn more about CoverMyMeds’ Provider Medication Alerts solution. Read on for Clay’s insights.

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Production Drugs 84

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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.

Clinical Supply

STAT News

JANUARY 13, 2023

SAN FRANCISCO — Carbon Health is in a turbulent time: The primary care tech company has had two recent rounds of layoffs and announced plans to dial back major business lines. Yet it still managed to score  $100 million in new funding from CVS Health Ventures   and launched a new, high-tech primary care partnership with Blue Cross Blue Shield of Massachusetts.

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Marketing 94

Fierce Pharma

JANUARY 13, 2023

AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales. kdunleavy. Fri, 01/13/2023 - 09:29.

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Sales Marketing Drugs 104

NPR Health - Shots

JANUARY 13, 2023

The CDC has expanded screening of incoming international air travelers to try to more quickly spot any new variants that might emerge from China's massive COVID outbreak.

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Outsourcing Pharma

JANUARY 13, 2023

A license agreement from UCB to Pheno Therapeutics will enable the acceleration of a promising new drug tackling neurological diseases towards clinical development.

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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.

Clinical Trials

Fierce Pharma

JANUARY 13, 2023

Roche searches pharma chief Anderson's successor from within: chairman. aliu. Fri, 01/13/2023 - 09:36.

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NPR Health - Shots

JANUARY 13, 2023

Gas stoves have been in the news as the Consumer Product Safety Commission researches emissions and health effects. NPR Climate Desk's Jeff Brady sorts the misinformation from the facts.

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Fierce Pharma

JANUARY 13, 2023

New Biogen CEO tips subcutaneous lecanemab to help expansion into pre-symptomatic Alzheimer’s. ntaylor. Fri, 01/13/2023 - 09:33.

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NPR Health - Shots

JANUARY 13, 2023

Nearly 16 million people have already signed up for health insurance through the Affordable Care Act. There are still three more days to sign up. (Story aired on ATC on Jan. 12, 2023.

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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.

Clinical Trials