Wed.Jan 03, 2024

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JPM24, Day 2: BioNTech warns of COVID vaccine sales decline; Alnylam looks to become 'top-tier' biopharma player

Fierce Pharma

As the J.P. | As the J.P. Morgan Healthcare Conference rolled on in San Francisco, BioNTech, Alnylam and many other companies updated investors on their strategies heading into 2024.

Biopharma 289
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Goldman Sachs Closes $650M Fund to Invest in ‘Golden Era’ of Biotech Innovation

MedCity News

Goldman Sachs’s new fund—its first dedicated to life sciences—will focus on early- to mid-stage therapeutics companies with multiple assets. Genetic medicine, cell therapy, immunotherapy, and artificial intelligence are among the areas of investment interest for the firm.

Medicine 119
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Trending Sources

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With trial win for oral thalassemia drug, Agios charts broader path than gene therapy rivals

Fierce Pharma

Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients. | Gene therapies have been approved for certain patients with beta thalassemia. After a successful phase 3 readout, Agios hopes it can reach a unique subgroup and eventually all patients.

Patients 275
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Aetna Better Health of Kentucky, Av?sis and MapHabit Launch Pilot Program for Vulnerable Patients

MedCity News

Aetna Better Health of Kentucky, Avēsis and MapHabit have teamed up to support 200 Kentucky children with autism or intellectual disabilities. The pilot program will help the patients with activities of daily living, such as oral hygiene.

Patients 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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JPM24, Day 3: Alkermes enters new phase after busy year

Fierce Pharma

As the J.P. Morgan Healthcare Conference moves into its third day, we're covering the latest developments here. | On Wednesday at the the J.P. Morgan Healthcare Conference, attendees will get a chance to hear from AbbVie, Amarin and several other pharmaceutical companies.

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BJC-St. Luke’s Merger Will Be ‘the First of Many’ M&A Deals in the Hospital Sector This Year

MedCity News

On New Year’s Day, two Missouri health systems — St. Louis-based BJC HealthCare and Kansas City-based St. Luke’s Health System — officially completed their merger. The combined health system comprises 28 hospitals and hundreds of clinics serving 6 million people, and it is expected to generate $10 billion in annual revenue.

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Alleviating Patient Burden in Clinical Trials: Modeling a Consumer-Grade Experience

MedCity News

By leveraging analytics to optimize the patient experience in clinical trials, patient attrition will decrease, improving clinical outcomes and research goals.

Patients 115
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JPM24, Day 1: Moderna touts $6.7B in '23 sales; Bluebird has cash on hand to last until early 2025

Fierce Pharma

As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. | As the J.P. Morgan Healthcare Conference kicked off in San Francisco, EY released its annual report on the industry's dealmaking firepower. Plus, Moderna, bluebird and other companies updated investors on their businesses heading into 2024.

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CardioMech Snags $13M For Its Mitral Valve Repair Tech

MedCity News

Medical device startup CardioMech raised $13 million to advance the development and validation of its flagship device, which is designed to treat degenerative mitral valve regurgitation. The catheter-based device seeks to offer an uncomplicated, direct procedure for patients eligible for open-heart surgery as well as those considered eligible for the surgery.

Medical 108
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Pfizer rings in New Year with hemophilia B gene therapy nod in Canada

Fierce Pharma

After a pair of high-profile approvals for sickle cell disease gene ther | After a pair of high-profile approvals for sickle cell disease gene therapies in the U.S. last month, Pfizer is ushering in the New Year with a regulatory endorsement for its hemophilia B gene therapy north of the border.

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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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From Last Resort to Mainstay: The Evolution of ECMO in Critical Care

MedCity News

The evolution of ECMO from a last-resort intervention to a mainstay of modern critical care is a testament to the relentless pursuit of better patient outcomes in the field of medicine. Unfortunately, despite the immense life-saving capability of this therapy, it remains vastly underutilized.

Medicine 105
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GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

Fierce Pharma

When GSK laid out $90 million upfront to acquire rights to Scynexis’ antifungal Brexafemme last spring, the British pharma threw a lifeline to a company whose blockbuster launch ambitions had hit t | GSK has downgraded a licensing deal for Scynexis' antifungal ibrexafungerp following an ongoing recall of the drug's approved form, Brexafemme.

Pharma 202
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MHRA authorisation is first endocrine therapy innovation in decades

European Pharmaceutical Review

Korserdu ® (elacestrant) is the first treatment indicated for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations. The endocrine therapy has been granted a marketing authorisation by the UK Medicines & Healthcare products Regulatory Agency (MHRA). This represents the first endocrine therapy innovation in nearly 20 years. The small molecule treatment is authorised for postmenopausal women, and men, with oestrogen receptor (ER)-positive, HER2-negative, locally advanced

Medicine 105
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Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement

Fierce Pharma

After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement. | The agreement amends terms of the companies' 2019 partnership on heart med Nexletol and dismisses Esperion's lawsuit over milestone payments ahead of a potential European label expansion.

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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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MHRA’s post-Brexit mutual recognition framework goes live

pharmaphorum

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

Medicine 102
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Regulatory tracker: Menarini's Korserdu becomes UK's first new endocrine cancer fighter in decades

Fierce Pharma

Welcome to 2024's regulatory tracker for Fierce Pharma. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Pharma 130
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Expert analysis: the latest in HIV research and clinical trials 

Pharmaceutical Technology

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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Outsourcing regulatory activities in pharma

European Pharmaceutical Review

Outsourcing has become a necessity for many pharmaceutical companies; even the outsourcing of regulatory functions has grown over the past several years and is expected to increase steadily in future. The pharmaceutical regulatory affairs outsourcing market is thus projected to rise from $7 billion in 2022 to $15 billion in 2032, 1 driven by the growing number of clinical trial applications (see Figure 1 ) 2 and product registrations.

Pharma 89
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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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UK should remove blocks on phage research as AMR fears rise

pharmaphorum

UK report calls for the mothballed Rosalind Franklin Lab to be repurposed as a manufacturing unit to support clinical trials of bacteriophages as new antimicrobial agents

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Boehringer reinforces interest in NASH with new $2bn deal  

Pharmaceutical Technology

This collaboration comes six years after the German company Boehringer signed two agreements to develop treatments for NASH.

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Developing micro QC for ATMPs

European Pharmaceutical Review

What are the top trends relating to sterility testing of ATMPs? For me, one of the most promising developments involves the use of the next-generation sequencing-based sterility test (NGSST), which uses whole genome amplification and sequencing followed by microorganism identification with 48 hours. 1 This method removes the requirements for a culture period and has a higher accuracy than other rapid testing methods such as ATP bioluminescence.

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Novartis allies with Voyager to develop gene therapies in $1.3bn deal

Pharmaceutical Technology

Novartis will pay Voyager $100m upfront and up to $1.2bn in milestone-based payments and royalties on net sales.

Sales 98
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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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AnX Robotica receives FDA clearance for small bowel capsule endoscopy technology

PharmaTimes

NaviCam ProScan is the first AI-assisted reading tool for gastrointestinal bleeding

FDA 104
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Inside the world of priority review vouchers where ‘time is money’ – Part I

Pharmaceutical Technology

The first of a two-part series on therapies that receive an FDA priority review designation dives into how these vouchers incentivise innovation for low-commercial value-diseases.

FDA 59
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Novo Nordisk to open new AI hub in UK for drug discovery

PharmaTimes

The new hub will be located in the King’s Cross Knowledge Quarter, London

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The Weekly Wins of a Sales Superstar

Contrarian Sales Techniques

Navigating through a week in the sales world is like embarking on a mini-adventure, each day bringing its own set of challenges and triumphs. Let's break down the weekly routine of a sales superstar into beginning, middle, and end segments. This isn't just about getting through the week. It's about maximizing each day to its fullest potential. So, let's turn the pages of this weekly planner together.

Sales 59
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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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Invivyd Seeks EUA for Monoclonal Antibody Designed to Prevent COVID-19 in Immunocompromised Individuals

PharmExec

VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents.

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How to Get Into Medical Sales: A Comprehensive Guide

Rep-Lite

Medical sales is the field of selling medical products and services to healthcare providers, such as hospitals, doctors, and clinics. Medical sales representatives typically work for pharmaceutical companies, medical device manufacturers, or healthcare service providers. Medical sales reps play a vital role in bringing new and innovative products and treatments to the market.

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The Midday Mastery of a Sales Superstar

Contrarian Sales Techniques

I'm back, and this time we're diving into the midday routine of a sales superstar. You know, that crucial part of the day when energy levels can either skyrocket or take a nosedive. It's the halftime of your workday, and how you spend it can really set the tone for the second act. So, grab your favorite midday snack, and let's unwrap the secrets to keeping that sales spark alive post-noon.

Sales 52
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Why We’re Salesforce Managed Services Expert Navigators

Penrod

The Heart of Salesforce Managed Services Since our founding in 2011, we’ve met and exceeded the standards for world-class Salesforce support by setting our sights on enhancing efficiency for our clients. Our services model revolves around focusing only on the healthcare industry. Penrod is proud to announce that our recent Managed Services Expert Navigator status has positioned us as one of the top three solution integrators for Salesforce services in the Healthcare and Life Sciences indus

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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.