November, 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.

Biopharma 131
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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

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Highly Cited Researchers 2023: The evolution of our evaluation and selection policy to support a robust scholarly landscape

Clarivate

Every year, the unveiling of the Highly Cited Researchers list sparks anticipation within the global research community as both researchers and their affiliated institutions or organizations scrutinize the list. Today, we present our 2023 list , recognizing 6,849 individuals from more than 1,300 institutions across 67 countries and regions. These Highly Cited Researchers stand out for their significant and broad influence in various scientific and social science domains, representing a small fra

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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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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 Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis

PharmExec

Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.

Patients 119
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10 Ways AI/ML Technologies Can Enhance Software Quality in the Life Sciences Industry

PM360

Quality in software is a multifaceted concept, closely tied to both conformance to requirements and fit for purpose. In the life sciences industry, where software permeates everything from the drug discovery process to pharmaceutical supply chain management, the need for rigorous fit-for-purpose evaluations has never been more critical. As pharmaceutical regulations increasingly intersect with software development standards, the traditional approach to Computer System Verification (CSV) is falli

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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The Women’s Edge and The Boston Globe Again Name CCC to Top 100 Women-Led Businesses in Massachusetts List

Copyright Clearance Center

November 16, 2023 – Danvers, Mass. – The Women’s Edge , a nonprofit that supports female business leaders, in partnership with The Boston Globe , has announced CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, was named to its annual Top 100 Women-Led Businesses in Massachusetts list.

Education 116
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Health Canada approves Jazz’s cannabis derived seizure therapy

Pharmaceutical Technology

Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.

Patients 131
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AstraZeneca showed the pandemic isn’t over for immunocompromised patients. What’s next?

PharmaVoice

Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.

Patients 116
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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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AbbVie agrees $10.1bn deal to buy ImmunoGen

pharmaphorum

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

Marketing 112
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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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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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Glasses Provide Audible Prompts for Blind Wearers

Medgadget

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer as to their surroundings.

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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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FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy

PharmExec

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

FDA 111
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Strategies for Combination Therapy in Oncology: Part Two – Working with the “Status Quo”

PM360

This is the second article in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the U.S. and Europe. In this article, we investigate strategies that manufacturers could consider to optimize pricing and access opportunities for their combinations in today’s environment. (You can find part one here.

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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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FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

Biopharma 133
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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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Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

Fierce Pharma

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

Marketing 360
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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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Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

PharmExec

Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.

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AbelsonTaylor Group Receives the Healthcare Businesswomen’s Association ACE Aspire Award for its Employee Psychological Safety Initiative

PM360

Award-winning health and wellness advertising agency AbelsonTaylor Group received the inaugural ACE Aspire Award for its employee Psychological Safety Initiative from the Healthcare Businesswomen’s Association (HBA). The Award was presented yesterday at the HBA Annual Conference in Chicago. The HBA’s ACE (Advancement. Commitment. Engagement.) Awards recognize companies committed to ensuring that gender diversity and leadership opportunities for women are part of their organizational DNA.

Safety 111
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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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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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U.K. Is First to Approve a CRISPR-Based Therapy, Covering Two Blood Disorders

MedCity News

Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is now approved in the United Kingdom for treating the blood disorders sickle cell disease and beta thalassemia. It’s the first regulatory approval in the world for a CRISPR-based therapy.

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Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Fierce Pharma

Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. | Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. The move is a consequence of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.

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How to succeed in biotech: A serial entrepreneur’s tips for surviving tough times

PharmaVoice

John Mulligan, founder of biotechs like Good Therapeutics and Bonum Therapeutics, discusses how biotechs can thrive when the market is against them.

Marketing 111
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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2024 Pipeline Report: First-World Focus

PharmExec

Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.

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NHS trials artificial intelligence system to prevent avoidable admissions

PharmaTimes

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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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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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.