Thu.Feb 22, 2024

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After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

Fierce Pharma

As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new owner in the U.S. | As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new U.S. owner in Rigel Pharmaceuticals.

Medicine 268
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Meet the Marketplace Providers Are Using to Overcome the ‘Notorious Challenge’ of Radiology AI Adoption

MedCity News

About 80% of all FDA-approved healthcare AI applications are related to radiology — but due to a massive workforce shortage, radiologists don’t have the time to explore, choose, validate and implement the tools available to them. Some providers are using a radiology AI marketplace called CARPL to address this problem, including Massachusetts General Hospital and University Hospitals.

FDA 114
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Sanofi, Regeneron get a step closer on Dupixent COPD nod with FDA priority review

Fierce Pharma

Regeneron and Sanofi have reached another milestone as they look to add to their megablockbuster immunology drug Dupixent a new U.S. | Regeneron and Sanofi have reached another milestone is their advancement of Dupixent (dupilumab) as a potential treatment for uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation as the FDA has accepted the companies’ application and designated it for priority review with a target action date of June 27.

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Novavax and Gavi Settle Dispute Over Covid Vaccines Pact, Avoiding Arbitration

MedCity News

By settling now and agreeing to deferred payments over the next five years, Novavax avoids the risk of being responsible for a much bigger payout all at once. The arbitration hearing over the disputed vaccine purchase agreement with Gavi was scheduled for this summer.

Biopharma 108
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Amid contract manufacturing wind-down, Moderna advances production efforts for cancer programs

Fierce Pharma

To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. | To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. The Cambridge, Massachusetts-based biotech has incurred a COVID-related wind-down charge on one hand, while it spends millions of dollars to bolster cancer vaccines at the same time.

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Analyzing PCSK9 Inhibitor Use in Adults With Cardiovascular Disease

Pharmaceutical Commerce

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

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More Trending

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CCC to Host Town Hall on Copyright, Artificial Intelligence, and the Training of Large Language Models

Copyright Clearance Center

February 22, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will host the Town Hall event “The Heart of the Matter: Copyright, AI Training and LLMs” via LinkedIn Live on Thursday, 29 February, 11:00 EST/16:00 GMT. A panel of legal experts including Prof. Daniel Gervais , Vanderbilt University Law School, and Prof.

Training 103
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Fierce Pharma Asia—Daiichi’s €1B expansion; Astellas’ $800M cell-therapy bet; Novartis India’s strategic review

Fierce Pharma

Daiichi Sankyo is building additional antibody-drug conjugate capacity at its German site. Astellas partnered with Kelonia on cell therapy tech. | Daiichi Sankyo is investing 1 billion euros to expand its German site. Astellas partnered with Kelonia on cell therapy tech. Novartis launched a strategic review of a subsidiary in India that's focused on older meds.

Pharma 154
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Resources, Industry Support Will Help Primary Care Practices Meet Increased Medicare Demand for CGM

MedCity News

Now more than ever, enhancing primary care practices to include CGM capabilities is a crucial goal requiring the support and involvement of the broader healthcare community.

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Pfizer’s Litfulo becomes first NHS drug for alopecia areata

pharmaphorum

NICE has backed NHS use of Pfizer’s Litfulo for patients with alopecia areata, the first drug therapy for a condition that affects around 14,000 people

Patients 101
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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 Startups, Time is Running Out to Enter the MedCity INVEST Pitch Perfect Contest in Chicago

MedCity News

Are you a biopharma startup focused on oncology? A devices /diagnostics startup focused on cardiology? Or a health tech startup focused on how consumers/employers are addressing women’s health? If so, submit an application for MedCity INVEST Pitch Perfect by February 29!

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Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study

Pharmaceutical Technology

US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.

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Five Strategies To Boost Clinical Trial Diversity

MedCity News

Without taking specific steps to improve trial diversity, advances in inclusive treatments will continue at a snail’s pace.

Patients 117
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Immunocore and BMS partner to investigate first-line treatment for melanoma

Pharmaceutical Technology

The company will evaluate an IMC-F106C/Opdivo combination treatment in a Phase III registrational study called PRISM-MEL-301.

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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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Women’s Health Startup Pledges $10M for Women’s Health Research

MedCity News

Perelel’s $10 million pledge comes in the form of product donations and funding grants and will go to the Magee-Womens Research Institute and the Good+Foundation through 2027.

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Innovation to drive advanced drug delivery market

European Pharmaceutical Review

A report by Towards Healthcare has forecasted that the advanced drug delivery market will value $375.86 billion by 2033. The year 2023 was “significant” for the progress of advanced drug delivery systems, the author reflected. Last year, with a size of $234.84 billion, the market witnessed “remarkable advancements that promise to reshape healthcare landscapes across the globe”.

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Aptar buys digital health partner Healint

pharmaphorum

More digital health consolidation as Aptar buys Healint, a specialist in patient support apps and software to run virtual clinical trials and patient registries

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NICE recommends first medicine for severe alopecia areata

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended LITFULO ® (ritlecitinib) for treating certain patients with severe alopecia areata. This is “an important milestone” according to Lynn Clay, Specialty Care Lead at Pfizer UK. The once daily oral capsule is indicated as a treatment option in individuals who are 12 years and older.

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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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FDA accepts Regeneron’s BLA for linvoseltamab for review

Pharmaceutical Technology

The FDA has accepted Regeneron’s biologics licence application (BLA) for linvoseltamab to treat multiple myeloma for priority review.

FDA 97
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New brain cancer proton beam therapy clinical trial launched in UK

PharmaTimes

The trial is recruiting patients in Leeds, Manchester, Oxford, London, Cambridge and Kent

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Regeneron set for August FDA decision on BCMA bispecific

pharmaphorum

Regeneron should hear from the FDA in August on its application for multiple myeloma bispecific linvoseltamab after a priority review.

FDA 80
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NHS launches new campaign to help patients get treatment from pharmacies

PharmaTimes

Pharmacy First will enable patients to receive treatment for seven common conditions

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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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FDA warns over smartwatches, rings for blood glucose testing

pharmaphorum

FDA warns against use of wearable smartwatches and smart rings that claim to measure blood glucose, which are all unapproved medical devices.

FDA 70
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Building a High-Performing Sales Team for Your Medical Device

Rep-Lite

Small medical device companies often face unique challenges such as limited resources, intense competition, and a need for precise and compliant communication. Navigating through these challenges can be daunting, but knowing how to build a sales team can be the key to success. But building a high-performing sales team will need a ton of strategy, hard work, and persistence.

Sales 52
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First-in-Class Novel Therapy for Chronic Myelomonocytic Leukemia Granted FDA Orphan Drug Designation

Pharmaceutical Commerce

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

FDA 52
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The 2024 PM360 Pharma Choice Awards – Multicultural Bronze Winner

PM360

Bronze Winner – Verywell Health Verywell Health’s Health Divide: Menopause & Black Women Verywell Health’s Health Divide: Menopause & Black Women sheds light on health inequities experienced by Black women going through menopause by providing information about disparities like increased likelihood and severity of symptoms, reduced access to care, and more.

Pharma 52
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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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Study Finds Parkinson Disease Drug Nearly Matches Wegovy in Weight Loss Effects

PharmExec

Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease.

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The 2024 PM360 Pharma Choice Awards – Philantrophic Bronze Winner

PM360

The Considered, The Opt-In, Men4Choice, New Voices for Reproductive Justice, and Prochoice Majority Speak Up Man One in five men have been party to an abortion. Yet most remain silent in the fight for reproductive freedom. This series of deeply personal interviews with men from very different walks of life drove to SpeakUpMan.com, where users could find out how to vote to protect abortion.

Pharma 52
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Driving the UK’s “innovation engine” for novel AMR therapeutics

European Pharmaceutical Review

In recent months, Pharma and biotech have seen promising developments in line with their efforts to help overcome global antimicrobial resistance (AMR). The discovery and use of antibiotics brought about a groundbreaking transformation in the treatment of bacterial infections, substantially reducing the number of deaths associated with microorganism-related diseases in humans and animals.

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The 2024 PM360 Pharma Choice Awards – Professional Campaign Bronze Winner

PM360

Deerfield Agency and Beiersdorf Eucerin Sun Product Launch The launch of Eucerin® Sun was a sequential, omnichannel effort made up of three key milestones: reestablishing the clinical standard, introducing a groundbreaking antioxidant complex, and the unveiling of the full product line. Each milestone was pivotal in not only driving recommendations and sales, but also in delivering optimal sun protection for all.

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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.