Sat.Nov 11, 2023 - Fri.Nov 17, 2023

article thumbnail

CHMP recommends new immunotherapy delivery method

European Pharmaceutical Review

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.

Medicine 105
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 360
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

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

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

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

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

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.

More Trending

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 116
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

Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Fierce Pharma

Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. | Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.

FDA 299
article thumbnail

Report: Workers Trust Employers More Than Insurers With Their Health

MedCity News

Just 37% of employees trust their insurer to suggest high-quality care regardless of cost, while 53% trust their employer with their health, according to a survey released by Included Health.

Insurance 118
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

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.

110
110
article thumbnail

Reaching New Global ‘Frontiers’ In Life Sciences

Eversana Intouch

Last week, Frontiers Health, the premier global digital health innovation event, was held in Rome, Italy. The annual event assembled nearly 1,000 attendees from over 40+ countries across the healthcare ecosystem to learn, network and explore industry challenges, strategic trends and solutions in life sciences and healthcare. While Frontiers Health has always been a flagship event for EVERSANA INTOUCH and our clients to attend each year, this year’s event was significant as we were proud to co-ho

article thumbnail

Pharma is racing to oncology's first line, causing a rethink of early-stage disease treatment

Fierce Pharma

Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas' MD Anderson Cancer Center. | Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner.

Pharma 291
article thumbnail

Gilead’s $285M Confidence Vote for Next-Gen Cancer Med & New Cell Therapy Tech

MedCity News

Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.

Leads 116
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

How Digital Twins Drive Sustainability in Clinical Supply Planning

PharmExec

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.

Safety 105
article thumbnail

Odysseys with Ivy Cohen

PM360

PM360 asked Ivy Cohen, President and CEO, Ivy Cohen Corporate Communications, about the place she just can’t stop returning to. Ivy and her mother join in to choose the finale winner. My Odyssey: For the past seven years (with a couple year COVID gap), my husband, mother, and I attend Amateur Night at The Apollo—The Grand Finale on the night before Thanksgiving.

article thumbnail

Germany considers banning the export of Novo Nordisk's Ozempic

Fierce Pharma

How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? | How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? The craze is such that Germany’s drug regulator is considering banning the export of Ozempic, according to a report in Der Spiegel magazine.

286
286
article thumbnail

Why Healthcare is the Perfect Place For AI to Shine

MedCity News

In reality, the healthcare sector is, in many ways, the ideal place for AI to be used. After all, it’s one of the few industries with access to a treasure trove of precisely the kind of high-quality data with which AI operates best.

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

First CRISPR-based gene-editing therapy authorised

European Pharmaceutical Review

Casgevy (exagamglogene autotemcel), also known as exa-cel, is the first treatment to be licensed that uses CRISPR. It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia.

Safety 96
article thumbnail

Novo Nordisk to Discontinue Levemir for Diabetes Mellitus

PharmExec

Novo Nordisk said it will continue providing Levemir vials and the Levemir FlexPen for diabetes control while supplies last, until the full product discontinuation at the end of 2024.

97
article thumbnail

AstraZeneca’s first-in-class FDA approval for Truqap marred by surprise restriction

Fierce Pharma

After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. | After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. But an unexpected restriction has cast a dark cloud over the first-in-class approval.

FDA 284
article thumbnail

Report: Many Found Renewing Medicaid Coverage Easy, But Some Faced Barriers

MedCity News

New KFF focus groups revealed that some thought the process of renewing Medicaid coverage during the unwinding of the continuous enrollment provision was simple. Others, however, faced challenges with communication from state Medicaid agencies, and some weren’t aware their coverage had been terminated.

113
113
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

Micron Biomedical receives funds to produce needle-free vaccines

Pharmaceutical Technology

Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

article thumbnail

Unified vision essential in UK advanced manufacturing

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. This ‘manifesto for growth’, developed by the Manufacturing Five (M5), a coalition of the UK’s leading advanced trade associations, proposed the reforms necessary for the UK to close the gap with global competitors and growth of innovative manufacturing in the country.

article thumbnail

AstraZeneca plans to exit 'beating heart' of Indian operations in Bangalore

Fierce Pharma

Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing. AZ plans to find a buyer who can also serve as a contract manufacturer for the drugs produced there.

article thumbnail

We’re at a Turning Point for Alzheimer’s Disease Research

MedCity News

Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease.

article thumbnail

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.

article thumbnail

World’s first CRISPR-based gene therapy approved for sickle cell anaemia

Pharmaceutical Technology

Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.

105
105
article thumbnail

Guide to Outsourcing 2023

European Pharmaceutical Review

Outsourcing regulatory activities in pharma Here, EPR’s Editor explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities. Accelerating drug development for simple and complex drug programmes Quotient Sciences leverages more than 30 years of drug development expertise to support small molecule and synthetic peptide drug programmes, in both simple drug programmes as well as complex cases where specialised formulation e

article thumbnail

2seventy suffers sales slump on high production charges for BMS-partnered CAR-T med Abecma

Fierce Pharma

If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.

Sales 277
article thumbnail

From Inequality to Empowerment: The Role of Automation Technologies in Healthcare

MedCity News

Automation can be a powerful tool to bring together all the pieces needed to provide optimal care that can be scattered across various systems and apps. Whether it’s to exchange patient data quickly and easily, identify communities in need of programs to address food inequity, or reduce no-shows by sending automatic reminders, using the right technology is an essential tool for achieving better patient care.

article thumbnail

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.