November, 2023

article thumbnail

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
article thumbnail

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.

363
363
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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

article thumbnail

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
article thumbnail

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

article thumbnail

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
article thumbnail

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

More Trending

article thumbnail

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.

FDA 363
article thumbnail

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
article thumbnail

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
article thumbnail

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 115
article thumbnail

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.

article thumbnail

FDA Approves Zepbound for Chronic Weight Management

PharmExec

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

article thumbnail

Why Generative AI Threatens Hospital Cybersecurity — and How Digital Identity Can Be One of Its Greatest Defenses

MedCity News

While more generative AI tools are becoming available in healthcare for diagnostics and patient communication, it is important for clinicians and healthcare staff to be aware of the security, privacy, and compliance risks when entering protected health information (PHI) into a tool like ChatGPT.

article thumbnail

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.

363
363
article thumbnail

Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

PharmaTimes

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

117
117
article thumbnail

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

article thumbnail

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.

116
116
article thumbnail

??A startling drop in U.S. life expectancy — and how pharma could help turn the tide

PharmaVoice

The recently observed dip was particularly acute for men, who now live an average of 5.8 fewer years than women.

Pharma 115
article thumbnail

AstraZeneca joins KRAS push in cancer with Chinese deal

pharmaphorum

AstraZeneca joins KRAS push in cancer with Chinese deal Phil.

129
129
article thumbnail

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.

article thumbnail

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.

article thumbnail

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 361
article thumbnail

Samay’s AI-assisted wearable technology accurately diagnoses COPD

PharmaTimes

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

Patients 127
article thumbnail

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.

124
124
article thumbnail

Humans can’t shake the mosquito threat. Here’s what pharma has in the pipeline.

PharmaVoice

The arsenal against the world’s deadliest creature is growing and a universal vaccine is in the works.

Pharma 116
article thumbnail

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.

article thumbnail

Bayer launches support tool for diabetic kidney disease

pharmaphorum

Bayer launches support tool for diabetic kidney disease Phil.

117
117
article thumbnail

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 135
article thumbnail

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.

article thumbnail

Milner Therapeutics to establish new genomics laboratory for drug discovery

PharmaTimes

The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes

123
123
article thumbnail

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.

article thumbnail

Cloud in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.

Pharma 114
article thumbnail

Tools like ChatGPT can personalize clinical trials tech — if companies avoid the pitfalls

PharmaVoice

From hallucinations to data privacy, pharma looks to iron out the kinks of generative AI.

Pharma 115
article thumbnail

Victoria Atkins replaces Barclay as UK health secretary

pharmaphorum

Victoria Atkins replaces Barclay as UK health secretary Phil.

116
116
article thumbnail

Expert: The Rumored Humana/Cigna Combination Makes Sense

MedCity News

With Cigna mostly focused on the commercial market and Humana mostly focused on the Medicare Advantage market, the rumored combination rumors check out, according to one industry expert.

Marketing 132
article thumbnail

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.