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

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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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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

Sales 116
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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.

Marketing 109
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Modernising drug delivery through gel-based technology

European Pharmaceutical Review

Accessibility, as well as optimised nutrient and medicine release, are the driving forces behind modernising drug delivery. With millions around the world struggling with dysphagia and other conditions that affect their ability to take pills and other medications, innovative delivery methods with gel-based platforms are necessary to promote greater accessibility and medication adherence.

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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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Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

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How Copyright Clearance Center’s Michael Healy Advocates for ‘Responsible AI‘

Copyright Clearance Center

In a rapidly evolving publishing landscape, the executive director of the CCC is taking the lead on addressing one of the industry’s most pressing concerns: the use of copyrighted material in artificial intelligence systems.

Leads 98

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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?

European Pharmaceutical Review

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. With the recent failure of Lykos’ trial, how do you see the future of psychedelic therapies in research, especially in treating disorders like depression, PTSD, and substance use diso

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Jazz's HER2 bispecific snags FDA nod, teeing up showdown with AZ and Daiichi's Enhertu

Fierce Pharma

A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate Enhertu | A bispecific antibody has entered the HER2 fray with a differentiated profile from traditional agents and a chance to challenge AstraZeneca and Daiichi Sankyo’s star ADC Enhertu.

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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).

Pharma 94
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Eliminating Barriers and Increasing Access to New Testing to Improve Prenatal Care

MedCity News

New advancements can only be fully realized when clinicians, lawmakers, and patients come together. Biomarker tests not only have the potential to improve patient outcomes and address health equity, they can also decrease expenses for financially vulnerable medical systems. The post Eliminating Barriers and Increasing Access to New Testing to Improve Prenatal Care appeared first on MedCity News.

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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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Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

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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.

FDA 290
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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.

FDA 92
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

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Plasma specialist Grifols shrugs off private equity firm Brookfield's potential €6.5B takeover offer

Fierce Pharma

With Spanish plasma specialist Grifols turning down a potential multi-billion-dollar takeover bid, it’s likely back to the drawing board for Canadian private equity outfit Brookfield. | Grifols’ board of directors on Tuesday rebuffed private equity firm Brookfield’s potential 6.45 billion euro buyout offer, recommending management reject the deal that it argues “significantly undervalues the company’s fundamental prospects and its long-term potential.

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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.

Medicine 104
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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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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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Kura Oncology partners Kyowa Kirin to advance AML treatment

Pharmaceutical Technology

Kura has partnered Kyowa Kirin in a strategic global collaboration for developing and commercialising oral ziftomenib to treat AML

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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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Novartis raises mid-term sales outlook on pipeline promise

pharmaphorum

Novartis has raised its guidance for sales growth out to 2029 on the strength of its pipeline and the potential of late-stage R&D assets

Sales 84
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Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases. The post Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose appeared first on MedCity News.

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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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Wes Streeting says patients should view data sharing ‘the same as taxes’

Pharmaceutical Technology

UK Health Secretary Wes Streeting outlaid the key shifts needed to fix a “fragmented” NHS at the Jefferies London Healthcare Conference.

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Novartis, after slimming down, boosts growth projection through the end of the decade

Fierce Pharma

As he introduced Novartis’ meet-the-management event Thursday in London, CEO Vas Narasimhan hammered home Novartis’ status as a streamlined, “pure-play, innovative medicines” company and the succes | Novartis has adjusted its compound annual growth rate expectation from 5%-plus to 6%-plus through 2029. The Swiss company cited the momentum of its current growth drivers, which have paved the way for a strong sales performance this year.

Medicine 251
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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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World Class Health Snags $8M To Expand Global Centers of Excellence Network

MedCity News

World Class Health’s $8 million in seed funding was led by AlleyCorp. The company serves self-funded employers and offers access to a global centers of excellence network. The post World Class Health Snags $8M To Expand Global Centers of Excellence Network appeared first on MedCity News.

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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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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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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.

FDA 219
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FDA experts lukewarm on AZ's anticoagulant antidote Andexxa

pharmaphorum

AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexaa to full approval in the US.

FDA 92
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Value-Based Care Is a Four Layer Cake — Why Do We Only Focus on The Icing?

MedCity News

During a recent panel discussion, three healthcare experts discussed reasons why value-based care is struggling to reach scale. The post Value-Based Care Is a Four Layer Cake — Why Do We Only Focus on The Icing? appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time