Tue.Oct 31, 2023

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As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

Sales 328
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The New Era of Programmable Biology

MedCity News

While legacy pharma companies battle in court with government agencies over how to address the costs that result from antiquated drug development paradigms, a growing cadre of compute-enabled life science companies are unlocking the nascent power of next-generation compute technologies to transform drug discovery and development.

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Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up growth plan

Fierce Pharma

As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff. | As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff.

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48 Senators Urge Biden Administration To Mandate Coverage of OTC Contraceptives

MedCity News

Several senators wrote a letter to the Biden Administration asking for action that ensures coverage of over-the-counter birth control without the need for a prescription. The letter was led by Senators Patty Murray (D-Washington), Tammy Baldwin (D-Wisconsin), Bernie Sanders (I-Vermont) and Ron Wyden (D-Oregon).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Galapagos plans to cut 100 jobs after striking deal to transfer Jyseleca, 400 staffers to Alfasigma

Fierce Pharma

For 170 million euros plus royalties, Galapagos has transferred Jyseleca and its operations to Alfasigma. The deal includes 400 employees who will transfer to Alfasigma.

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CCC Hosts Annual ‘We Not Me’ Global Volunteering Event

Copyright Clearance Center

Oct. 31, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider, held its annual ‘We Not Me’ global volunteering event as part of a year-round charity initiative about demonstrating the power of individual action to build community and support the common good. CCC US-based staff collaborated with colleagues in various parts of the country including Massachusetts, New Hampshire, Rhode Island, Oregon, Washington, and California, serving

Education 114

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Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

MedCity News

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease. Analysts say prospects of the therapy, Elevidys, rest on FDA willingness to exercise flexibility it has already shown to rare disease drugmakers, including Sarepta.

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Amid COVID slump, Pfizer turns attention to RSV launch and a potential future in obesity

Fierce Pharma

As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market.

Marketing 211
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MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Jeff Smith, CEO of Bamboo Health

MedCity News

For the October episode, we discuss some recent executive hires and departures occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Jeff Smith, who became the new CEO of Bamboo Health this month.

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Catalent faces another possible revenue 'cliff' after Sarepta's gene therapy trial miss: analyst

Fierce Pharma

Even as Catalent dusts itself off from a pandemic sales plunge, the company may be teetering on the edge of another contract manufacturing precipice. | Catalent—just now getting past its “COVID cliff”—could face an “Elevidys cliff” after its partner Sarepta missed the mark in a confirmatory trial for its Duchenne muscular dystrophy gene therapy, analysts at William Blair wrote in a note to clients.

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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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Eli Lilly Strikes $250M Deal to Add Gene-Editing Medicines for Cardio Conditions

MedCity News

Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target.

Medicine 108
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Teamwork for Better Healthcare Solutions: Merging Clinical and Marketing Efforts

PharmExec

In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.

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How Tech is Saving Time for Specialty Pharmacies and Improving the Patient Experience [Sponsored]

MedCity News

In an interview, Surescripts’ Clinical Product Advisor Cecelia Byers shared how the company is working to simplify prescribing and obtaining specialty medications.

Patients 107
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Weekly injection shows promise for type 1 diabetes

European Pharmaceutical Review

Insulin icodec, a once-weekly basal injection to treat type 1 diabetes, has the potential to be as effective in managing the condition as daily basal insulin treatments, according to results of the year-long ONWARDS 6 Phase IIIa clinical trial, recently published in the Lancet. The study, conducted at 99 sites across 12 countries tested the efficacy and safety of a weekly basal injection of icodec (a long-lasting type of insulin) and compared it to a daily basal injection of insulin degludec in

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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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Bacteria Tag Team Tumors with T Cells

Medgadget

A team at Columbia University School of Engineering and Applied Science has developed a technique to enhance chimeric antigen receptor (CAR) T cell therapy in solid tumors. The technique involves engineering E. coli bacteria, that naturally tend to accumulate in the immune privileged core of solid tumors. The bacteria have been engineered to interact with tumor cells and deposit a synthetic antigen on the cells that can then be targeted by CAR T cells.

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ArriVent’s lung cancer therapy gains FDA breakthrough therapy status 

Pharmaceutical Technology

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

FDA 105
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Eko’s Newest CORE 500 Stethoscope: A Review

Medgadget

Arriving in two boxes reminiscent of Apple product packaging – one for the chest piece (the part that contacts the body), and another for the detachable earpiece (tubes + ear tips) – the CORE 500 is clearly an upgrade from the Eko DUO stethoscope. Similar to its predecessor, the CORE 500 can be used with your own headphones, smart phone, and just the chest piece, making it free of any hassle with the earpiece tubes.

Leads 91
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NHS patients to be offered the opportunity to travel for treatment

PharmaTimes

Around 400,000 eligible patients are set to benefit from the travel offer - News - PharmaTimes

Patients 116
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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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Exploring China’s research landscape and its future direction

Clarivate

Our latest Global Research Report from the Institute for Scientific Information (ISI) charts China’s research trajectory and its path of growth, quality and international collaboration. Over the last 40 years China’s research economy has experienced remarkable transformation and growth. China has emerged as a leading science and technology power on the global stage, rivaling western nations including the U.S.

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10 Crucial Ways Healthcare Companies Utilize Salesforce Managed Services

Penrod

The post 10 Crucial Ways Healthcare Companies Utilize Salesforce Managed Services appeared first on Penrod.

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High-performance computing could improve therapy for hard-to-treat cancer

PharmaTimes

Researchers reduced 4D-MRI image reconstruction times to 60 seconds - News - PharmaTimes

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Roche’s $7B Roivant deal was a ‘moment of opportunity,’ CEO says

PharmaVoice

Roivant CEO Matt Gline and Telavant CEO Frank Torti know Roivant’s position as buyers and sellers in the pharma industry, and they’re embracing those opportunities.

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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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Paychecks with Purpose: How Compensation is Changing in Medical Sales

Contrarian Sales Techniques

I decided to dive deep into the world of medical sales compensation plans. It's fascinating to see how things are shifting, especially with the rise of value-based selling. I've always been curious about how sales reps are rewarded for their hard work, and it seems the landscape is evolving. The Old Ways: Commission-Based Rewards The Good Old Days of Commissions I remember when medical sales reps were mostly paid based on the number of sales they made.

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Exploring sustainable cooling solutions for freeze dryers

PharmaTech

This article addresses new alternatives in industrial refrigeration systems ready to comply with current and future regulations, applicable for both new and existing freeze

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The Business Case for RWE

Pharmaceutical Commerce

How drugmakers can better harness real-world evidence to drive their clinical and commercial objectives, while also providing greater clarity for healthcare providers and improved access to therapy for the patients they serve.

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Despite trial miss, Sarepta plans new filing for DMD therapy

pharmaphorum

Despite trial miss, Sarepta plans new filing for DMD therapy Phil.

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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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Half of top 20 biopharma company market cap impacted amid the IRA in Q3 2023

Pharmaceutical Technology

Leading biopharmas are reshaping their strategies after the announcement regarding the first drugs subject to Medicare price negotiations under the Inflation Reduction Act (IRA).

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Team Building Leadership: Empowering Your Team to Achieve Greatness

Rep-Lite

In today’s dynamic and interconnected business landscape, the role of leadership has evolved beyond the traditional top-down approach. In this new era, where collaboration and cohesion are paramount, team-building leadership is a cornerstone for achieving success and excellence within organizations. Let’s discuss team-building leadership as a management and leadership approach.

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How Sales Leaders Are Incorporating Quickly Evolving AI Sales Tools into Their Toolkit

Quantified

While AI tools are a trending topic and have a vast potential to change business practices for the better—they can be overwhelming. Business tools are evolving overnight to incorporate bits of AI functionality wherever possible, and business leaders across every industry are fighting an endless wave of potential that makes it hard to pick a course of action, let alone stay on that course.

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Ortho Development® Announces Launch of the BKS® Uni Partial Knee System

Legacy MEDSearch

Ortho Development Corporation, a designer and manufacturer of orthopedic implants and instruments for hip and knee joint replacement surgery, today announced the launch of BKS® Uni, the latest addition to its portfolio of Balanced Knee® implant systems. BKS Uni is a partial knee replacement system designed to preserve bone, simplify surgical technique, and leverage the clinical heritage of the Balanced Knee System.

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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.