Sat.Sep 02, 2023 - Fri.Sep 08, 2023

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New Product Planning: The Function's Evolution in Pharma

PharmExec

With an organization's future commercial success under its remit, the NPP function has rapidly progressed to a prominent role in the biopharma industry—but evidence-generation strategies must evolve with an eye toward emerging trends and technologies.

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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

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HHS Issues Proposal Bolstering Nondiscrimination Protections For People With Disabilities

MedCity News

HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.

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Neuroplast spinal cord injury study milestone

PharmaTimes

The trial analyses the impact of its ‘Neuro-Cells’ among patients with traumatic spinal cord injuries - News - PharmaTimes

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Improving Health Equity and Diversity Throughout the Life Sciences

PM360

Since 2020, diversity, equity, and inclusion (DE&I) has been a prime area of attention within healthcare and the life sciences. For one, the pandemic put a spotlight on the disparity within clinical trials—in 2020 the FDA found that 75% of trial participants were white, 11% were Hispanic, 8% were Black, and 6% were Asian. Furthermore, the rise of the Black Lives Matter movement at the time forced organizations in all industries to take a closer look at their DE&I efforts and inspired som

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Patent cliffs, divestitures and maturing biotechs all point to more pharma M&A: analysts

Fierce Pharma

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. | Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.

Biopharma 334

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CRISPR-Equipped Bacteria Detect Tumors

Medgadget

Researchers at the University of California San Diego have created a bacterial sentinel system that can alert clinicians to the presence of tumors. The technology takes advantage of the specificity of the CRISPR system and the tendency of bacteria to uptake fragments of DNA from their environment. Termed “Cellular Assay for Targeted CRISPR-discriminated Horizontal gene transfer” (CATCH), the system has been created to detect gastrointestinal tumors in its first iteration.

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Unconventional Approaches Pharma Is Taking to Engage Patients

PM360

The “Kama Sutra” for Parkinson’s patients. A card game designed to help hemophilia patients exercise. A virtual product launch for patients akin to an iPhone debut. Documentaries, children’s books, Marvel comics, and interactive zines. All of these are examples of how companies are taking a little more unconventional approach to patient engagement. “The notion of radical empathy is something that has guided us when engaging patients,” says Ryan Mason, Chief Marketing and Creative Officer, Fishaw

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J&J's patient assistance program suffers data breach, IBM says

Fierce Pharma

IBM disclosed "unauthorized access" to J&J’s Janssen CarePath patient assistance program, which helped over 1 million U.S. patients last year.

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Recursion Vets Unveil Startup Noetik, Using AI to Unlock Tumor Biology

MedCity News

By revealing how tumors interact with immune cells, Noetik aims to identify new targets for new cancer drugs. The startup and its artificial intelligence-driven platform are supported by $14 million in seed financing.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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NICE recommends new type 2 diabetes treatment

European Pharmaceutical Review

Eli Lilly ’s Mounjaro (tirzepatide), has been recommended to treat poorly controlled type 2 diabetes in adults alongside diet and exercise. National Institute for Health and Care Excellence (NICE) final draft guidance recommends tirzepatide as a new treatment option for this indication. Compared with semaglutide , insulin therapy or a placebo, tirzepatide demonstrated that 81 percent to 97 percent of people achieved better glucose control in clinical trials.

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Nestlé divests peanut allergy treatment Palforzia to Stallergenes Greer

Pharmaceutical Technology

Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.

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Novartis files suit against IRA after blockbuster Entresto makes CMS' price negotiations list

Fierce Pharma

Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act (IRA). | Add Novartis to the list of biopharma giants that have filed lawsuits against the U.S. government as a reaction to the Inflation Reduction Act. The case was filed Friday in New Jersey federal court, three days after the CMS revealed that Novartis’ heart failure treatment Entresto was among 10 drugs subject to price negotiations in 2026.

Biopharma 295
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Alignment Health: What Are Seniors’ Top Barriers to Care?

MedCity News

A new survey from Alignment Health found that economic instability, food insecurity, lack of support and transportation access are the biggest social barriers for seniors.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Alzheimer’s senescent cell combination therapy presents promise

European Pharmaceutical Review

A Phase I trial employing the drug dasatinib has shown promise in clearing senescent cells in Alzheimer’s. Recent drugs targeting beta-amyloid plaques have only yielded modest results, according to the study researchers. Instead, the current US study pursued cellular senescence as an alternative area of focus. The findings published in Nature Medicine described how the US Food and Drug Administration (FDA)-approved tyrosine kinase inhibitor dasatinib was used in combination with quercetin, a pla

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Strategies for Success in an Evolving Commercialization Landscape

PharmExec

A phased launch approach may ultimately be more sustainable and enable maximum market penetration and commercial success with less upfront investment than traditional “go-for-broke” strategies.

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Astellas withdraws IRA lawsuit after avoiding CMS' price negotiations list

Fierce Pharma

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). | Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act. But now that the Centers for Medicare & Medicaid Services has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation.

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MA Beneficiaries With Cancer Spend Less on Healthcare Than Traditional Medicare Beneficiaries

MedCity News

Medicare Advantage beneficiaries with a cancer diagnosis spend $3,996 on out-of-pocket costs and premiums annually, versus $6,091 for traditional Medicare beneficiaries with cancer, a new report found.

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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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QA/QC & Environmental Monitoring In-Depth Focus 2023

European Pharmaceutical Review

Leveraging PAT for environmental monitoring in light of Annex 1 The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which is due to enter into force in August.

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The Stories That Shine

PharmExec

One of the most special things about Pharmaceutical Executive®, in my opinion, is when people share their stories—where they came from; how their upbringing or education or background impacted their desire to work in pharma; any personal ties to their work, such as finding new treatments in a specific disease state due to a loved one having been impacted by that same disease; and just generally sharing their passion for their work.

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BlueWhale Bio surfaces with $18M on mission to overhaul cell therapy production

Fierce Pharma

University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing. | Cell therapy manufacturer BlueWhale Bio uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by Danaher Corporation.

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5 Foundational Capabilities Needed for Implementing a Value-Based Care Program

MedCity News

Apprehension among practices and providers is understandable, given the complexity and variance of VBC contracts. However, instead of feeling overwhelmed and burdened by VBC, practices can slowly embrace these concepts by leveraging the many tools they already have in place or that exist in the healthcare ecosystem.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Bioprocessing & Bioproduction In-Depth Focus 2023

European Pharmaceutical Review

How breakthrough CAR-T cancer therapies could be made more widely accessible The development and regulatory approval of the first autologous CAR T-cell therapies is a huge advance for modern medicine and has been greeted with justifiable excitement. But applications of this technology are still limited, and given the time and cost constraints, more must be done to broaden access to this treatment.

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Hope sputters for emerging anti-TIGIT drug class

PharmaVoice

Leaked data for Roche’s immunotherapy appeared positive, but some experts aren’t convinced it’ll make an impact for cancer patients.

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Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

Fierce Pharma

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq. | Roche may not receive the FDA's decision on a subcutaneous version of its cancer immunotherapy Tecentriq on time thanks to the agency's requirement for changes to the drug's manufacturing process.

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Nursing Homes Reject CMS’ Proposed Staffing Level Requirements

MedCity News

CMS released a proposed rule to establish staffing standards among the nation’s nursing homes. Reactions have been mixed — but mainly negative. Long-term care facilities say that they can neither find nor afford more workers. On the other hand, some lawmakers argue the proposed rule doesn’t do enough to protect care quality for patients. As for labor unions, they seem generally happy with the rule.

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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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Semaglutide weight loss injection launched in UK

European Pharmaceutical Review

Novo Nordisk’s semaglutide injection Wegovy ® is now available as a treatment for obesity in the UK. The pharmaceutical company stated it believed that the launch of Wegovy will help provide an additional option to support people living with obesity in the UK. The semaglutide injection is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management.

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Brainomix’s e-Lung enters TIPAL trial

PharmaTimes

The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes

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J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertension

Fierce Pharma

Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag. | J&J’s Janssen has decided to stop a phase 3 trial for a high dose of Opsumit in a subtype of pulmonary hypertension. With the flop, J&J loses a chance to challenge Bayer's Adempas.

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Taming the Healthcare Data Beast: Conquering Complexity for Better Care

MedCity News

By following these foundational data best practices, healthcare organizations will harness the power of their data to provide superior patient care while safeguarding patient privacy and compliance.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time