Fierce Pharma

JANUARY 12, 2024

When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. | A group of 24,000 users of Gilead's TDF-based HIV meds argue that the company knowingly shelved a safer HIV med to increase its profits. Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.

Manufacturing 220

Manufacturing 220

MedCity News

JANUARY 12, 2024

New research found that there are no racial disparities in weight loss results among patients taking obesity drugs. However, the study found that people of color have less access to services like behavioral care or surgical interventions, which are often needed in order for obese patients to lose weight and keep it off.

Patients 109

Patients 109

Fierce Pharma

JANUARY 12, 2024

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. | A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.

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FDA 207

MedCity News

JANUARY 12, 2024

The innovator’s mindset is shifting from solving the problems right in front of us to solving problems once considered impossible to fix. The lines between curable and incurable diseases are blurring in surgery because medical devices are scaling up precision and scaling down the size of anatomy that surgeons can operate on.

Medical 105

Medical 105

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Fierce Pharma

JANUARY 12, 2024

While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers. | While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers. That’s proven true in obesity, where the company recently introduced its dual-action GIP/GLP-1 agonist Zepbound against Novo Nordisk’s Wegovy.

Competition 130

Competition FDA 130

Pharmaceutical Commerce

JANUARY 12, 2024

An overview of a structural approach that guides development of the analytics and related reporting that may assist brands in gaining or maintaining reimbursement positions and maximizing sales.

Sales 104

Sales 104

European Pharmaceutical Review

JANUARY 12, 2024

Using an investment of €120 million, Boehringer Ingelheim is set to expand and upgrade its production site in Koropi, Greece. New technologies at the facility will support the increased manufacturing capacity, the company stated on X. The expansion will boost exports of medicines from Greece to the US market. This will be the case particularly for Jardiance ® , a treatment for type 2 diabetes, chronic heart failure and chronic kidney disease (CKD), according to Boehringer Ingelheim.

Manufacturing 96

Manufacturing Medicine Pharmaceutical Pharma 96

MedCity News

JANUARY 12, 2024

U.S. healthcare is unnecessarily spending millions of dollars on scopes—dollars that could be better spent opening up new service lines, investing in medical equipment, or hiring nurses for improved patient care.

Healthcare 95

Healthcare Healthcare Medical Patients 95

pharmaphorum

JANUARY 12, 2024

Lantheus has filed what it says is the first generic version of Novartis’ big-selling cancer radionuclide therapy Lutathera in the US, used to treat rare neuroendocrine tumours (NETs). The FDA has started a review of the generic and – if approved – Lantheus could be in line for 180 days of market exclusivity as the first company to bring a copycat version of Lutathera (lutetium Lu 177 dotatate) to the US market.

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FDA Marketing 79

European Pharmaceutical Review

JANUARY 12, 2024

A recent survey from the Pistoia Alliance revealed that AI and machine learning (ML) will be the top technology investment for 60 percent of life sciences companies over the next two years. 1 AI and machine learning (ML) will be the top technology investment for 60 percent of life sciences companies over the next two years” With this increased focus on AI/ML, EPR editor Caroline Peachey sat down with Henry Levy, President of Life Sciences at Clarivate, to discuss the status, challenges a

Pharma 78

Pharma Pharmaceutical Recruitment Pharmaceutical products 78

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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.

Safety

pharmaphorum

JANUARY 12, 2024

Researchers from the Wellcome Sanger Institute and partners have carried out a comprehensive analysis of cancer cells, identifying 370 ‘priority’ targets that could be used to develop new drug therapies.

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Pharmaceutical Technology

JANUARY 12, 2024

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

Manufacturing 98

Manufacturing 98

European Pharmaceutical Review

JANUARY 12, 2024

According to a paper published in Bioprocess Control , as an advanced process control method, Model Predictive Control (MPC) can optimise biomanufacturing operations and ensure consistent product yields. With biological systems becoming increasing complex, alongside expanding demand for precision in drug development and manufacturing, advanced process control methods that can ensure consistent product yields and high-quality outputs in bioproduction are becoming vital, the researchers acknowledg

Biopharma 76

Biopharma Manufacturing Pharmaceutical 76

pharmaphorum

JANUARY 12, 2024

Bayer’s AskBio gene therapy unit has started recruiting patients into a phase 2 trial of its AB-1002 candidate for congestive heart failure.

Recruitment 84

Recruitment Patients 84

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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

Distribution

PharmaTimes

JANUARY 12, 2024

If successful, the new test could see routine screening introduced in the NHS

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100

pharmaphorum

JANUARY 12, 2024

The FDA says it can find no evidence of increased risk of suicidal thoughts and self-harm with GLP-1 drugs like Novo Nordisk's Ozempic and Wegovy

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FDA 77

PharmaVoice

JANUARY 12, 2024

From regulatory concerns to leadership skills, pharma leaders at JPM shared how they’re approaching the coming year.

Pharma 78

Pharma 78

PharmaTimes

JANUARY 12, 2024

Researchers compared 20 years of antibiotic use on E.

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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.

Safety

Pharmacy Times

JANUARY 12, 2024

BrainSee creates a new standard for progression prediction in Alzheimer disease, marking a step forward in brain health management with non-invasive screening.

FDA 71

FDA Management 71

Pharmaceutical Technology

JANUARY 12, 2024

The US Department of Defense procurement contract for Emergent’s BioThrax is comprised of an initial five-year base agreement.

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64

Pharmatutor

JANUARY 12, 2024

Overview of FDA Drug approvals in 2023 - Total Guide admin Sat, 01/13/2024 - 11:38 In 2023, FDA approved 55 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as expanding the use or patient population of previously approved drugs.

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FDA Marketing Patients 52

Contrarian Sales Techniques

JANUARY 12, 2024

"Mr. Johnson gripped the steering wheel like a white-knuckled life raft, eyes wide as saucers as we navigated the dealership's obstacle course. 'Is this normal?' he croaked, as the shiny red SUV bounced over a speed bump like a startled gazelle. 'Because it feels like I'm about to launch us into orbit.' I chuckled, calming his nerves with a reassuring, 'Just testing the suspension, Mr.

Sales 52

Sales 52

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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.

Specialization

Penrod

JANUARY 12, 2024

Tracking Technologies and HIPAA OCR Guidelines In December 2022, OCR issued a Bulletin outlining health providers’ HIPAA obligations. An important aspect of this overview emphasizes that providers are not allowed to use tracking technologies in a way that would reveal Protected Health Information (PHI) in a manner inconsistent with HIPAA’s privacy standards.

Patients 52

Patients Healthcare Provider Electronics Healthcare 52

Pharmaceutical Commerce

JANUARY 12, 2024

The US Department of Defense awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all branches of the US military with BioThrax (Anthrax Vaccine Adsorbed) for use as pre-exposure prophylaxis against anthrax disease.

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pharmaphorum

JANUARY 12, 2024

Experts in clinical trial technology, design and execution will come together in a moderated discussion to explore these different facets of the opportunities created by AI, both traditional and generative.

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Pharmaceutical Commerce

JANUARY 12, 2024

Axon Therapy is a noninvasive system that sends magnetic pulses through the skin that stimulate damaged peripheral nerve cells involved in the body’s pain relief mechanism.

FDA 52

FDA 52

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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

Leads

PharmExec

JANUARY 12, 2024

Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.

Medical 52

Medical 52

Pharmaceutical Commerce

JANUARY 12, 2024

RemeGen Co. Ltd’s antibody-drug conjugate RC88 is being analyzed to treat platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

FDA 52

FDA 52

PharmExec

JANUARY 12, 2024

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

Marketing 52

Marketing 52

Pharmaceutical Commerce

JANUARY 12, 2024

Morgan Company report makes the case for expanding coverage for GLP-1s beyond diabetes treatment and into the weight loss class, but are employers on board?

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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.

Management