Sat.Nov 18, 2023 - Fri.Nov 24, 2023

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The Disconnect between R&D Costs and High Drug Prices

MedCity News

Multiple studies have shown no correlation between R&D costs and the launch price of new drugs though that is an argument often used by drugmakers to prevent a cap on pricing. Still, one way to keep costs low, is for organizations to leverage health technology like AI and improve formulary compliance.

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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Pharma 141
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Phone Attachment for Pupil Measurements with Any Skin Tone

Medgadget

A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those with a dark iris, which is more common in people with darker skin tones, because it can be challenging to distinguish between the iris and the pupil.

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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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New York Proposes Regulations For Stronger Hospital Cybersecurity

MedCity News

New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The state also put aside $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules.

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To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

Fierce Pharma

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victo | Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic.

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GSK propels its progress to Net Zero

European Pharmaceutical Review

Phase III trials of a low carbon version of GSK’s metered dose inhaler, Ventolin (salbutamol), using a next generation, lower carbon propellant, are set to start in 2024. The pharma company stated that if successful, it has the potential to reduce greenhouse gas emissions from use of the inhaler by approximately 90 percent. According to GSK, thirty-five million patients with respiratory conditions globally relying on its metered dose inhaler.

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The Power of Value-Based Digital Transformation for Specialties

MedCity News

There is a huge opportunity for specialties to play a critical role in complementing primary care and tertiary care by transforming into a sustainable model that is preventive, boundaryless, and one that empowers patients and caregivers.

Patients 131
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Pfizer's cost-savings mission continues with office shuffle, job cuts in Ireland

Fierce Pharma

Pfizer, working through a $3.5 billion cost-cutting drive, is not done yet making changes to its workforce in Ireland. | Pfizer's commercial office in Citywest, Dublin, will move to its Ringsend office building, the Irish Independent reports. The moves could end in more job cuts in the company's commercial division.

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What We’re Watching for 2024 – Top Trends in Market Access

Eversana Intouch

In the rapidly changing landscape of global markets, staying ahead of the curve is crucial for businesses aiming to expand and thrive. As we step into 2024, the realm of market access undergoes dynamic shifts influenced by technological advancements, policy changes, and evolving consumer behaviors. There are the usual suspects like evolving provider models, the continued transition to value-based care and pharma/biotech companies increased investment in “access,” but there are two trends that ar

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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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New Amgen immunotherapy could treat common solid tumour

European Pharmaceutical Review

Amgen’s new immunotherapeutic agent Tarlatamab has been shown in a Phase II trial to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer patients. The international DeLLphi-301study was investigated as a new anti-cancer treatment option for patients previously considered to be beyond treatment. Results from the trial were published in the New England Journal of Medicine.

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HHS Proposes Rule to Bolster Prohibitions Against Discrimination on the Basis of a Disability in HHS Programs

MedCity News

With proposed requirements ranging from accessible self-service kiosks to accessible medical equipment, the impact of this new rule will be wide-ranging with financial, operational, and practical consequences.

Medical 127
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Texas accuses Pfizer and contract manufacturer of providing ineffective ADHD drug to state's Medicaid program

Fierce Pharma

Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades.

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What Makes A Good Medical Sales Rep With Rob Bahna

Evolve Your Success

Success in medical sales is not only about knowledge, but also about the application of that knowledge, adapting proactively, and being aware of your impact in the room. In this episode, we have Rob Bahna discuss what truly makes a good medical sales rep. From his early beginnings to climbing the ladder of success, Rob provides a firsthand account of his journey through various leadership positions in medical sales.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

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Surviving and Thriving in the Age of AI: How Healthcare Leaders Can Learn What They Need to Know

MedCity News

AI may transform health care across the board, but not by itself. It’s a tool, and like any tool, it will work more effectively and more safely in trained hands. As the AI revolution continues to grow, we believe organizations should invest in that training now.

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With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma's patent tactics

Fierce Pharma

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. | The U.S. Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process. And it's Sanofi’s turn to land in the crosshairs.

Pharma 300
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Moderna completes next stage of UK R&D facility build

pharmaphorum

US biotech Moderna has completed the installation of its clinical laboratories at its new R&D facility in the UK dedicated to the discovery of new mRNA vaccines and therapeutics, part of a 10-year partnership with the government agreed last year that has been estimated to be worth around £1 billion.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Biohaven wants to muscle in on the Ozempic craze with a competing class of drugs

PharmaVoice

Biohaven and other companies are aiming to develop meds with a different mechanism of action that trim the waistline while building lean tissue.

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Merck Neuroscience Acquisition Brings a Startup With Parkinson’s, ALS Programs

MedCity News

Merck’s acquisition of Caraway Therapeutics adds programs for genetically defined neurodegenerative diseases. One of those programs addresses a target that was the focus of a different startup purchased by Merck in 2019.

Biopharma 122
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GSK aims to slash carbon emissions with next-generation inhaler

Fierce Pharma

Joining drugmakers like AstraZeneca and Novo Nordisk, GSK is making big strides in its quest to clean up its carbon footprint. | GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%.

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After FDA no, Almirall’s eczema drug gets EU okay

pharmaphorum

The European Commission has approved Almirall’s lebrikizumab as Ebglyss for the treatment of moderate-to-severe atopic dermatitis (AD), with an EU rollout set to start in Germany next year.

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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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Novo Nordisk to expand French production facilities

European Pharmaceutical Review

Novo Nordisk is investing over €2.1 billion (16 billion Danish kroner) to expand its production site in Chartres, France, supporting manufacture of its products for serious chronic diseases. Novo Nordisk’s multi-billion facility expansion This financial commitment will greatly strengthen manufacturing capacity, more than doubling the site’s footprint.

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PBMs Are in Regulators’ Crosshairs But Are Regulators Missing the Point?

MedCity News

Proposals targeting misaligned financial incentives, price transparency, and pharmacy access are important and necessary reforms. But the consequences of failing to address pharmacy benefit managers’ use of market power to block competition and extract monopoly profits from payers and consumers will not be limited to drug costs – it will change all of healthcare for generations.

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After protests, pharma industry reaches 'landmark' drug spending deal with UK government

Fierce Pharma

After blasting the U.K.’s drug pricing policy, the pharma industry has secured a new government spending deal featuring a higher revenue cap and an innovative drug-friendly rebate mechanism. | After blasting the U.K.’s drug pricing policy, the pharma industry has secured an improved government spending deal. The agreement will double the annual growth rate for prescription meds over the coming years.

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Stretchable E-Skin for Robotic Prostheses

Medgadget

Engineers at the University of British Columbia have collaborated with the Japanese automotive company Honda to develop an e-skin for robotic prostheses that allows such devices to sense their environment in significant detail. The soft skin is highly sensitive, letting robotic hands to perform tasks that require a significant degree of dexterity and tactile feedback, such as grasping an egg or lifting a glass of water without breaking it.

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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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BRUKINSA® granted significant EU approval in follicular lymphoma

European Pharmaceutical Review

BRUKINSA ® (zanubrutinib) in combination with the anti-CD20 monoclonal antibody obinutuzumab, has been approved by the European Commission (EC) to treat relapsed or refractory follicular lymphoma in individuals who have received at least two prior lines of systemic therapy. The oral treatment is now “the first Bruton’s tyrosine kinase (BTK) inhibitor approved in this indication and has the broadest label of any medicine in its class globally,” stated Dr Mehrdad Mobasher, Chief Medical Officer, H

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Eli Lilly Plans New $2.5B Manufacturing Site in Germany for Injectable Meds

MedCity News

The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs.

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AbbVie flexes litigation muscle with Rinvoq patent lawsuit against Sandoz, other generic players

Fierce Pharma

Looking to protect its lucrative immunology drug Rinvoq, AbbVie is suing a clutch of generic drug makers that are attempting to market copycat versions of the blockbuster. | In a lawsuit filed in Delaware federal court Monday, AbbVie accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceutical of trying to sidestep dozens of patents protecting Rinvoq through the next decade.

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Experts Believe Gene Therapy Offers Potential to Impact Gaucher Disease Market

Pharmaceutical Technology

According to several key opinion leaders (KOLs) interviewed by GlobalData, pipeline gene therapy holds the greatest potential to transform the Gaucher disease landscape

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.