Fierce Pharma

AUGUST 31, 2023

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson h | Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price by 55% to $130 for a six-month course.

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Competition 272

MedCity News

AUGUST 31, 2023

During past recessions, the healthcare sector remained relatively immune to economic downswings — but things are different now that a sweeping labor shortage and lower patient volumes have been added to the mix.

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Fierce Pharma

AUGUST 31, 2023

For the JAK inhibitor momelotinib, which GSK obtained in its $1.9 billion acquisition of Sierra Oncology, a three-month delay at the FDA was worth the wait. | For the JAK inhibitor momelotinib, which GSK obtained in its $1.9 billion acquisition of Sierra Oncology, the three-month extension of the FDA's review turned out to be worth the wait.

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FDA 239

MedCity News

AUGUST 31, 2023

When real-life failure is not an option, practicing curated, trial-and-error simulations in VR can reduce patient risk in high-acuity scenarios. With nursing faculty also in short supply and a wave rapidly approaching retirement age, virtual reality simulations can help bridge the gap between learners needing supervised clinical experiences, and time-pressed preceptors, who have their own patients to care for in addition to guiding novices in clinical settings.

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Patients 113

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Fierce Pharma

AUGUST 31, 2023

For six years, Sanofi's specialty care chief Bill Sibold has helped the company make the most of its Regeneron-partnered immunology superstar Dupixent. | Bill Sibold, who took over the company's specialty care unit in 2017 just after Dupixent's first approval, is leaving Sanofi effective immediately. The company further shook up its leadership by appointing a new R&D head, a chief digital officer and adding an entirely new position.

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European Pharmaceutical Review

AUGUST 31, 2023

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Based on new data from the Novartis Phase I/II clinical trial , which used the first therapy to target a new genetic area and use cryopreserved stem cells, trial participants reported a decrease in vaso-occlusive events.

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Food and Drug Administration Medicine Food FDA 110

MedCity News

AUGUST 31, 2023

Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.

Medicine 105

Medicine Marketing FDA Biopharma 105

Fierce Pharma

AUGUST 31, 2023

Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. | Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene.

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Pharma 192

MedCity News

AUGUST 31, 2023

Beginning September 1, HHS’ Office of the Inspector General will begin enforcing the anti-information blocking regulations laid out in the 21st Century Cures Act. EHR vendors are the entities that are most at risk of being fined — they could face penalties up to $1 million.

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Fierce Pharma

AUGUST 31, 2023

Introduction: | New to this year’s HLTH event, the Pharma & Life Sciences Insights Program, included with HLTH 2023 registration, will spotlight the transformative potential of advanced digital technologies and the impact of a robust digital health strategy on drug discovery, personalized treatments and improving patient outcomes. Bringing together esteemed panels of scientists, digital health experts, innovators and tech pioneers, the Insights program will explore the power and potential of

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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.

Safety

MedCity News

AUGUST 31, 2023

Through a new partnership, Castell will be able to refer members of its Utah health plan customers to Headspace for behavioral health coaching and therapy.

Healthcare 101

Healthcare Healthcare 101

Fierce Pharma

AUGUST 31, 2023

In this interview, Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, discusses Jazz’s 20-year legacy and what it means to create an organization that is both patient-focused and a great place | Jazz Pharmaceuticals’ Chairman and CEO discusses the company’s longstanding history of bringing new medicines to patients with limited or no options.

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Pharmaceutical Patients Medicine 130

PharmaTimes

AUGUST 31, 2023

The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes

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Pharmaceutical Technology

AUGUST 31, 2023

Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.

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Leads 105

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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

Distribution

PharmaTimes

AUGUST 31, 2023

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes

Patients 106

Patients 106

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. Medical researchers constantly develop innovative therapies and treatment options to improve survival and quality of life. In precision oncology, technological advances have made targeted radiotheranostics a promising option for diagnosing and treating solid tumours. Usually consisting of an injected medical radionuclide and a target molecule, radiopharmaceuticals precisely bind to tumours, destroying tumour cells wit

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Food and Drug Administration Manufacturing Safety Transportation 80

PharmaTech

AUGUST 31, 2023

The updated vaccine will be ready to ship following a positive European Commission review.

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European Pharmaceutical Review

AUGUST 31, 2023

[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities. A recent report by the Access to Medicine Foundation has highlighted the management of waste and steps that pharmaceutical manufacturers of antibiotics can take to limit the risk of antimicrobial resistance

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Manufacturing Medicine Management Pharmaceutical 77

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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.

Safety

MedCity News

AUGUST 31, 2023

Mental health company Two Chairs launched two new solutions Tuesday: group therapy and care navigation.

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Leads 90

Pharmacy Times

AUGUST 31, 2023

The seamless integration of artificial intelligence and machine learning has the potential to accelerate research and enhance efficiency in a new era of personalized medicine.

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Medicine 67

PharmaTech

AUGUST 31, 2023

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

Manufacturing 52

Manufacturing 52

PharmExec

AUGUST 31, 2023

How to navigate an ever-changing social world

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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.

Specialization

Scott’s Directories

AUGUST 31, 2023

In the rapidly evolving landscape of healthcare sales, generating qualified leads is a cornerstone of successful business growth. Integrating digital strategies has transformed the traditional approach, making healthcare lead generation a vital component of any sales plan. Therefore, having access to proper healthcare sales lead generation can make a difference.

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Healthcare Sales Leads Healthcare Healthcare 52

Spotio

AUGUST 31, 2023

The solar industry represents vast opportunities. But if you’re in solar sales, you know that it’s not all sunshine and rainbows. The field is highly competitive, and more often than not, multiple solar installers bid on every job. How can you succeed in this kind of environment? Should you even try, or should you take your ball and go home?

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Prospecting Sales Engineering Leads 52

Legacy MEDSearch

AUGUST 31, 2023

There are some important changes in the SMS world that will affect your business/career search/online shopping habits and more. We at Legacy MedSearch believe in keeping our network in the loop, so here’s a quick summary. The What and Why Starting August 31st, the Federal Communications Commission (FCC) is rolling out stricter regulations for automated SMS (text) communication.

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Recruitment Networking Management Medical 52

PharmExec

AUGUST 31, 2023

In this Pharm Exec Podcast episode, Gerald Kierce, co founder and CEO of Trustible, and Andrew Camino Chung, the company's CTO and co founder, delve into the realm of artificial intelligence, discussing Trustible's mission and its pioneering efforts to ensure ethical AI use, particularly in the pharmaceutical industry, and how it navigates complex AI regulations across the globe.

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Ethics Pharmaceutical 52

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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

Leads

PharmaTech

AUGUST 31, 2023

Twist Bioscience is a synthetic biology and genomics company that has developed a DNA synthesis platform to industrialize the engineering of biology, which is a new method of this process by “writing” DNA on a silicon chip.

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Engineering Pharmaceutical 52

PharmaVoice

AUGUST 31, 2023

Medicare just announced its first-ever drug price negotiations and legislators are quickly pushing to broaden the program.

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PharmaTech

AUGUST 31, 2023

A company focused on the treatment of advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-drying program.

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Pharmacy Times

AUGUST 31, 2023

Ferric carboxymaltose was not found to have a significant impact on 6-minute walk distance, which is part of the primary outcome’s hierarchical composite of death and hospitalizations from heart failure.

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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.

Management