Mon.Jan 09, 2023

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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

Sales 348
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4 Trends to Watch in 2023, According to a Digital Substance Use Disorder Company

MedCity News

There are several trends to watch out for in the substance use disorder space in 2023, according to CHESS Health’s CEO Hans Morefield. These trends include rising addiction rates and increased comfort in virtual health.

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Trending Sources

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JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023

Fierce Pharma

JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023. kdunleavy. Mon, 01/09/2023 - 10:34.

Sales 328
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Free access to Zolgensma curbed, says Novartis

pharmaphorum

Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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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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JPM23: Regeneron reports disappointing sales of powerhouse Eylea, says it's a 'blip'

Fierce Pharma

JPM23: Regeneron reports disappointing sales of powerhouse Eylea, says it's a 'blip'. kdunleavy. Mon, 01/09/2023 - 14:21.

Sales 298
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JP Morgan 2023 – Day 1

pharmaphorum

We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. Check below for updates throughout the day.

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More Trending

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CommonSpirit Health CEO at JPM: Some providers will be commodities

MedCity News

In an interview with MedCity News after his presentation at the J.P. Morgan Healthcare Conference, Wright Lassiter III said while some providers will be considered commodities, his vision for CommonSpirit Health is not to be “at the bottom of the totem pole.

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Teva's $4.25B opioid settlement gets support from 48 states and will move forward

Fierce Pharma

Teva's $4.25B opioid settlement gets support from 48 states and will move forward. zbecker. Mon, 01/09/2023 - 11:27.

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CVS Invests $25M in Virtual Mental Health Clinic

MedCity News

CVS Health invested $25 million in Array Behavioral Care, a provider of virtual mental health care. Last year, Array’s clinicians had more than 400,000 encounters with patients.

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JPM23: Ipsen scoops up liver disease specialist Albireo for $952M

Fierce Pharma

JPM23: Ipsen scoops up liver disease specialist Albireo for $952M. kdunleavy. Mon, 01/09/2023 - 08:57.

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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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Healthcare Hires of Note

MedCity News

Read about executive hires across healthcare and life science companies and organizations such as ProofPilot, Genentech, MassBio, Virgin Pulse, and more.

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JPM23: Bluebird touts gene therapy launch progress, extends cash runway to 2024

Fierce Pharma

JPM23: Bluebird touts gene therapy launch progress, extends cash runway to 2024. esagonowsky. Mon, 01/09/2023 - 09:26.

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Former Execs From Datavant & Grand Rounds Create Health Data Startup

MedCity News

Crescendo Health recently launched with a $3.4 million initial investment. The startup provides clinical researchers with software tools that make it easier to gather study participants’ longitudinal health data.

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Bristol Myers Squibb, Pfizer turned away from SCOTUS in high-profile cases

Fierce Pharma

Bristol Myers Squibb, Pfizer turned away from SCOTUS in high-profile cases. kdunleavy. Mon, 01/09/2023 - 11:48.

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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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Neurocrine Commits $175M to Voyager in New Neuro Gene Therapy Alliance

MedCity News

Neurocrine Biosciences is paying $175 million up front for rights to a preclinical Voyager Therapeutics gene therapy that could put the biotech in competition with Eli Lilly among other companies. Voyager could earn up to $1.5 billion in milestone payments.

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JPM23: BMS touts 'diversified' portfolio as launches kick into gear and old drugs near patent cliff

Fierce Pharma

JPM23: BMS touts 'diversified' portfolio as launches kick into gear and old drugs near patent cliff. aliu. Mon, 01/09/2023 - 14:20.

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M&A Monday: AstraZeneca Leads Way as Three Pharmas Splash Out $3.5B in Deals

MedCity News

AstraZeneca has committed $1.3 billion to acquire CinCor Pharma, a clinical-stage biotech whose lead drug candidate has the potential to treat hypertension in a new way. In other M&A news, Ipsen and Chiesi Farmaceutici each announced acquisitions of rare disease biotechs. All three deals come with contingent value rights.

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JPM23: Is Novartis weighing respiratory, eye drug sell-offs after Sandoz? Not necessarily, CEO says

Fierce Pharma

JPM23: Is Novartis weighing respiratory, eye drug sell-offs after Sandoz? Not necessarily, CEO says. aliu. Mon, 01/09/2023 - 16:06.

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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.

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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials.

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Upgrading Omnichannel Coordination to Improve Customer Centricity

PharmExec

"The customer is always right" — a commitment to omnichannel marketing is a commitment to serving the customer. David Laros of Beghou Consulting offers up this tersely written playbook on the topic.

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NourishedRx Launches Food Benefits Platform Powered by Google Cloud

MedCity News

NourishedRx is a food-as-medicine company that offers dietary assistance for health plans’ members through methods like medically-tailored meals, grocery support and diet education. Through the new platform, NourishedRx is able to communicate with its food partners, health plan customers and members.

Food 110
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Alzheimer’s drug Leqembi to launch at discount to Aduhelm

pharmaphorum

Eisai and Biogen’s Alzheimer’s therapy Leqembi will be priced at $26,500 per year – a little less than misfired predecessor Aduhelm – after getting conditional authorisation for the drug from the FDA on Friday. The US regulator has granted accelerated approval to anti-amyloid therapy Leqembi (lecanemab) with a fairly broad label to treat patients in the mild cognitive impairment or mild dementia stage of disease who have confirmed presence of amyloid pathology.

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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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Novellia founders seek to use digitomics, precision data to speed up drug development

MedCity News

Healthcare startup Novellia’s platform seeks to digitally bring in all chapters of a patient’s health journey to allow clinicians and researchers to finally see the full story.

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Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. in an all-cash transaction at $14.50 per American Depositary Share (ADS). Each ADS represents five Amryt ordinary shares. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 billion, with upfront consideration of $1.25 billion representing a 107%

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AstraZeneca to acquire CinCor in nearly $2b deal

European Pharmaceutical Review

AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. for a transaction value of approximately $1.8 billion, represented by combined upfront and maximum potential contingent value payments, if achieved. If the acquisition is completed, AstraZeneca will gain rights to CinCor’s drug candidate baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension.

Pharma 93
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The kindred nature of martial arts and drug development

PharmaVoice

How the IRLAB Therapeutics CEO is guiding the company in its development of potentially groundbreaking Parkinson’s disease treatments.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Cold Calling Tips for Medical Sales Reps

MedReps

The phrase “cold calling” tends to strike fear in the hearts of sales reps everywhere. Let’s be honest: no one enjoys making cold calls, as it can be tricky to quickly introduce yourself and your products to busy customers before they hang up. However, in order to meet those sales goals, cold calls have to be part of the equation because they are effective and can work quite nicely when done correctly.

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Making Pharmacy Benefits Transparent and Returning Control to Patients and Employers [Sponsored]

MedCity News

Transcarent wants to transform the digital pharmacy benefit experience, enabling self-insured employers and their staff to make more informed choices.

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FDA grants accelerated approval for Leqembi

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. The FDA’s decision means the drug is the second of a new category of medications approved for Alzheimer’s that target the fundamental pathophysiology of the disease. The agency’s judgement is based on trial results which showed Leqembi helped to reduce amyloid beta plaque.

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AstraZeneca makes CinCor Pharma acquisition

PharmaTimes

Agreement involves access to global rights of blood pressure lowering therapy baxdrostat

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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.