Sat.Nov 16, 2024 - Fri.Nov 22, 2024

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action

MedCity News

The DEA recently announced the third extension of Covid-19 flexibilities for the virtual prescribing of controlled substances. Telehealth advocates applaud this move but remain hopeful for a more permanent solution in the future. The post Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action appeared first on MedCity News.

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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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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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Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

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Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding

MedCity News

The Silicon Valley startup formerly known as Ciitizen relaunched as Citizen Health. The company seeks to empower patients with access to their complete health history — and it’s starting off by focusing on patients with rare diseases. The post Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding appeared first on MedCity News.

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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius

MedCity News

Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights. The post GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius appeared first on MedCity News.

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Syndax gets FDA okay for first-in-class leukaemia drug

pharmaphorum

Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another

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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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AHA 2024: Plozasiran demonstrates promising Phase III results in FCS adults

Pharmaceutical Technology

During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,

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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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Market Trends to Watch for Health Systems and Their Specialty Pharmacies

MedCity News

The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. The post Market Trends to Watch for Health Systems and Their Specialty Pharmacies appeared first on MedCity News.

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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

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AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

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Rapid growth spurt for UCB's Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval

Fierce Pharma

It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. | The latest nod positions Bimzelx to go head-to-head with Novartis' Cosentyx in the hidradenitis suppurativa market.

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Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025?

MedCity News

What concrete strategies should employers pursue to control rising costs while ensuring the best member experience and clinical outcomes? The post Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025? appeared first on MedCity News.

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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

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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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FDA approves Syndax’s Revuforj to treat leukaemia

Pharmaceutical Technology

The US FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating acute leukaemia with KMT2A translocation.

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Amid Seattle downsizing, Gilead cuts 100+ positions at California HQ

Fierce Pharma

The scope of Gilead Sciences' recent round of layoffs is coming into clearer view with the revelation that the company is planning more than 100 cuts at its corporate headquarters. | The scope of Gilead Sciences' recent round of layoffs is coming into clearer view with the revelation that the company is planning more than 100 cuts at its corporate headquarters.

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Don’t Erode Medical Device Trust with Right to Repair

MedCity News

Right to repair would undermine the FDA’s regulations and introduce unnecessary risk into the healthcare industry, threatening the high-quality care that doctors provide patients. The post Don’t Erode Medical Device Trust with Right to Repair appeared first on MedCity News.

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Tirzepatide gets a big win in obesity-related heart failure

pharmaphorum

Eli Lilly's tirzepatide has been shown to significantly cut cardiovascular risks in patients with obesity and a form of heart failure with few treatment options, in another big win for the GLP-1 receptor agonist class.The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly's drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.

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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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Workplace Shortages? Attract Top Talent With 5 Healthcare Recruitment Marketing Strategies

Healthcare Success

You know about competitive compensation, life-enhancing benefits, a supportive company culture, and a healthy work-life balance. But, how do you ensure that your marketing efforts truly differentiate your organization, giving you a competitive edge? We’ve gathered our top recruitment marketing strategies to help position your organization as an employer of choice and attract high-caliber professionals. 5 Healthcare Recruitment Marketing Strategies to Combat Workforce Shortages 1.

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With patent settlement, BeiGene defends blockbuster Brukinsa from MSN's generic threat until 2037

Fierce Pharma

As BeiGene works to grow the reach of its cancer offerings, the company inked a patent settlement with MSN over its star medicine Brukinsa.

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Why AI Won’t Replace Human Psychotherapists

MedCity News

Despite AI’s growing ability to simulate empathy and even outperform humans in some areas of emotional awareness, can it truly replace human therapists and take the burden off the mental health care system? The post Why AI Won’t Replace Human Psychotherapists appeared first on MedCity News.

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Pfizer bags EU okay for haemophilia drug Hympavzi

pharmaphorum

Pfizer's Hympavzi has become the first once-weekly subcutaneous treatment for people living with severe haemophilia B in the EU

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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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Sanofi investment to enhance antibody bioproduction in France

European Pharmaceutical Review

Sanofi is investing over €40 million in its Lyon Gerland site, supporting antibody bioproduction in France. A portion of this, €25 million, will be directed toward production and development of Sanofi’s second generation of its polyclonal antibody Thymoglubulin. It is used for transplantation and is manufactured exclusively at the Lyon Gerland site, Sanofi stated.

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Eisai sunsets development, access program for withdrawn obesity med in Dravet syndrome

Fierce Pharma

In the wake of a market pull in obesity nearly five years ago, the other shoe has dropped for Eisai’s serotonin 2C receptor agonist lorcaserin. | Eisai has terminated a phase 3 study of lorcaserin as a potential adjunct treatment for patients with Dravet syndrome, a rare form of epilepsy that starts in infancy. The company is also shutting down an extended access program in which patients were able to access the medication off-label.

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How Emory’s New Partnership Seeks to Scale Value-Based Care Across Georgia

MedCity News

Emory Healthcare in Atlanta announced a partnership with Guidehealth, value-based care enablement startup. The collaboration is designed to help primary care reach more than 350,000 patients across Georgia. The post How Emory’s New Partnership Seeks to Scale Value-Based Care Across Georgia appeared first on MedCity News.

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MSD says subcutaneous Keytruda matches IV form

pharmaphorum

MSD's subcutaneous formulation of top-selling cancer drug Keytruda was non-inferior to the current intravenous version in a head-to-head trial

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time