European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.

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Food and Drug Administration FDA Medical Food 98

pharmaphorum

JANUARY 7, 2025

Verona Pharma's plans to transform COPD treatment with recently approved Ohtuvayre look like they are on course, given early sales figures.

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Sales Pharma 104

PharmaTimes

JANUARY 7, 2025

OAV101 IT expands potential for type II SMA patients

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Patients 83

pharmaphorum

JANUARY 7, 2025

A man in Louisiana has become the first recorded fatality in the US attributed to the H5N1 strain of bird flu.

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Advertiser: ZoomInfo

Incorporating generative AI (gen AI) into your sales process can speed up your wins through improved efficiency, personalized customer interactions, and better informed decision- making. Gen AI is a game changer for busy salespeople and can reduce time-consuming tasks, such as customer research, note-taking, and writing emails, and provide insightful data analysis and recommendations.

Sales

MedCity News

JANUARY 7, 2025

FIRE1 raised $120 million for its Norm system a heart failure monitor implant that seeks to keep patients out of the hospital. The post Irish Startup Snags $120M for Heart Failure Implant appeared first on MedCity News.

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Patients 78

pharmaphorum

JANUARY 7, 2025

GSK has claimed its second breakthrough designation from the FDA for B7-H3-targeted ADC, this time in osteosarcoma.

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FDA 90

pharmaphorum

JANUARY 7, 2025

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area

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Pharmaceutical Technology

JANUARY 7, 2025

Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.

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PharmaTech

JANUARY 7, 2025

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

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FDA 59

PharmaVoice

JANUARY 7, 2025

New formulations for under-the-skin application of drugs give pharmas another opening in a crowded market.

Patients 59

Patients Pharma Marketing 59

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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.

Sales Management

PharmaTech

JANUARY 7, 2025

The transaction, which was first announced in September 2024, expands Phillips Medisizes inhalation drug delivery capabilities.

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Pharmaceutical Technology

JANUARY 7, 2025

The FDA has accepted for filing and priority review Sentynl Therapeutics CUTX-101 NDA for the treatment of Menkes disease.

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FDA 59

PM360

JANUARY 7, 2025

Acquisition highlights companies shared commitment to clients, workplace culture, and attracting the industrys best people TORONTO, ON/SARATOGA SPRINGS, NY January 7, 2025 Klick Health today announced it has acquired Peregrine Market Access, a leading market access strategy and value communications specialist in life sciences. The acquisition strengthens Klick Healths position and ongoing investment in the increasingly important value, access, and reimbursement segments within life sciences co

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Pharmaceutical Technology

JANUARY 7, 2025

The transaction is expected to close in the first half of 2025, subject to the satisfaction of customary closing conditions.

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Advertiser: ZoomInfo

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Sales Strategy

Pharmacy Times

JANUARY 7, 2025

Despite these concerns, experts have emphasized that the benefits of RSV vaccination outweigh potential risks for older adults, who are at heightened risk of severe RSV-related illness.

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FDA 52

Pharmaceutical Technology

JANUARY 7, 2025

Candid plans to conduct first-in-human studies in 2026 as it continues its T-cell engager deal drive.

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PharmaTech

JANUARY 7, 2025

Webinar Date/Time: Wed, Feb 5, 2025 11:00 AM EST

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Pharmaceutical 52

Pharmaceutical Technology

JANUARY 7, 2025

The FDA has granted ODD to Tempest's amezalpat (TPST-1120), for individuals with hepatocellular carcinoma (HCC).

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FDA 59

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PharmExec

JANUARY 7, 2025

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Marketing 52

Pharma Marketing Network

JANUARY 7, 2025

Table of Contents Sr# Headings 1 Introduction: Why Pharma Marketing Matters 2 Digital Dominance in Pharma Marketing 3 Personalization: The Future of Engagement 4 Regulatory Updates Impacting Pharma Ads Introduction: Why Pharma Marketing Matters The world of pharmaceutical marketing is evolving rapidly, and staying informed is no longer optional for executives.

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Marketing Pharma Media Healthcare Provider 52

Pharmaceutical Technology

JANUARY 7, 2025

Acelyrin plans to initiate two Phase III studies this quarter, which will enrol up to 350 patients with thyroid eye disease (TED).

Patients 52

Patients 52

Pharma Marketing Network

JANUARY 7, 2025

Table of Contents Sr# Headings 1 Introduction: The Importance of Marketing in Pharma 2 Digital Strategies Redefining Pharma Marketing 3 Building Trust Through Patient-Centric Campaigns 4 Navigating Compliance While Innovating Introduction: The Importance of Marketing in Pharma Marketing in pharma has never been more critical. In todays rapidly evolving landscape, executives must navigate a complex mix of innovation, regulation, and competition to remain relevant.

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Advertiser: ZoomInfo

As prospects define their problem, search for solutions, and even change jobs, they are generating high-value signals that the best go-to-market teams can leverage to close more deals. This is where signal-based selling comes into play. ZoomInfo CEO Henry Schuck recently broke down specific ways to put four key buying signals into action with the experts from 30 Minutes to President’s Club.

Prospecting

PharmExec

JANUARY 7, 2025

Breakthrough Therapy Designation for GSK5764227 was based on data from the ARTEMIS-002 Phase II trial, which demonstrated promising efficacy and safety in 42 osteosarcoma patients.

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Safety FDA Patients 52

Pharma Marketing Network

JANUARY 7, 2025

Table of Contents Sr# Headings 1 Introduction: Big Pharma and Public Perception 2 Transparency: The First Step to Trust 3 Humanizing Big Pharma Through Patient-Centric Marketing 4 The Role of Community and Corporate Responsibility Introduction: Big Pharma and Public Perception The term Big Pharma often stirs strong emotions, conjuring both respect for its life-saving innovations and skepticism over perceived corporate motives.

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Pharma Media Marketing Patients 52

PharmExec

JANUARY 7, 2025

Fast Track designation was based on results from a Phase II study, which demonstrated that VGT-309 was safe, well-tolerated, and enhanced tumor visualization in lung cancer patients.

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FDA Patients 52

Pharmaceutical Commerce

JANUARY 7, 2025

The deal is expected to be finalized by the first half of this year.

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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

Patients

PharmaTech

JANUARY 7, 2025

With the new $94 million (90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.

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Medicine 52

pharmaphorum

JANUARY 7, 2025

Another clinical trial setback disappoints the ALS patient community, this time involving Denali's eIF2B agonist DNL343.

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Patients 52

Pharmaceutical Commerce

JANUARY 7, 2025

The latest news for pharma industry insiders.

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Pharma FDA 52

PharmExec

JANUARY 7, 2025

While challenges remain, AI is accelerating the process by enabling researchers to identify and design new drug candidates more quickly and efficiently with applications in target discovery, structure prediction, and drug optimization.

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Advertiser: ZoomInfo

Sales and marketing leaders have reached a tipping point when it comes to using intent data — and they’re not looking back. More than half of all B2B marketers are already using intent data to increase sales, and Gartner predicts this figure will grow to 70 percent. The reason is clear: intent can provide you with massive amounts of data that reveal sales opportunities earlier than ever before.

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