Tue.Jan 07, 2025

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FDA issues first recommendations on AI for drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product.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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Verona says COPD drug is off to a flying start

pharmaphorum

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

Sales 101
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Irish Startup Snags $120M for Heart Failure Implant

MedCity News

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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US reports its first fatal case of H5N1 bird flu

pharmaphorum

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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5 Ways You Can Win Faster with Gen AI in Sales

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.

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Novartis gene therapy set to enhance SMA treatment

PharmaTimes

OAV101 IT expands potential for type II SMA patients

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GSK bags breakthrough status for bone cancer drug

pharmaphorum

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

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More Trending

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FDA issues first guidance on AI in medicine development

pharmaphorum

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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FDA Publishes Two Guidance Documents, One in Final Version

PharmaTech

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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Subcutaneous options offer convenience for patients — and a valuable window for drugmakers

PharmaVoice

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

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Molex, Phillips Medisize Close Acquisition of Vectura Group

PharmaTech

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

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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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Variant Bio and Novo Nordisk to identify targets for metabolic disease treatment

Pharmaceutical Technology

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

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Klick Health Acquires Peregrine Market Access, Further Cementing its Position as the Leading Go-To Commercialization Partner in Life Sciences

PM360

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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FDA accepts Sentynl’s Menkes disease therapy NDA for priority review

Pharmaceutical Technology

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

FDA 59
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FDA Requires Warning for Guillain-Barré Syndrome in Prescribing Information for RSV Vaccines

Pharmacy Times

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.

FDA 52
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10 Ways to Leverage Buyer Signals and Drive Revenue

In today’s ultra-competitive markets, it’s no longer enough to wait for buyers to show obvious signs of interest. Instead, sales teams must be proactive, identifying and acting on nuanced buyer behaviors — often before prospects are fully ready to make a purchase. In this eBook from ZoomInfo & Sell Better, learn 10 actionable ways to use these buyer signals to transform your sales strategy and close deals faster.

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WuXi Biologics to sell Ireland-based vaccine site to MSD for $500m

Pharmaceutical Technology

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

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Beyond Amorphous Solid Dispersions: Novel Applications in Pharmaceutical Spray Drying

PharmaTech

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

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Candid Therapeutics signs $925m T cell engager deal with WuXi Biologics

Pharmaceutical Technology

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

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Klick Health Acquires Peregrine Market Access

PharmExec

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

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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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FDA grants ODD to Tempest’s hepatocellular carcinoma treatment

Pharmaceutical Technology

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

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Top Pharma Marketing News and Trends for 2025: Insights for Industry Leaders

Pharma Marketing Network

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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Acelyrin stock plunges after positive Phase II data readout in thyroid eye disease

Pharmaceutical Technology

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

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Marketing in Pharma: Top Strategies for Executive Success

Pharma Marketing Network

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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Signal-Based Selling: How to Leverage 4 Key Buying Signals

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.

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FDA Grants Breakthrough Therapy Designation to GSK’s Novel Treatment for Relapsed or Refractory Osteosarcoma

PharmExec

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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Rebranding Big Pharma: Strategies to Build Trust and Connection

Pharma Marketing Network

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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FDA Grants Fast Track Designation to Vergent Bioscience’s Novel Agent for Visualizing Solid Tumors During Lung Cancer Surgeries

PharmExec

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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Merck Purchases WuXi Vaccine Plant in Ireland for $520 Million

Pharmaceutical Commerce

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

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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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With New Funding, Orbis Medicines to Develop Oral Macrocycles as Alternative to Biologic Drugs

PharmaTech

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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Denali slides after ALS drug flunks clinical test

pharmaphorum

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

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Pharma Pulse 1/7/25: FDA Issues Draft Guidance on AI in Supporting Regulatory Decisions, Strategic AI Budgeting for Pharmacies in 2025 & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 52
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Artificial Intelligence Makes Possible a Multiomic Approach in Oncology Drug Discovery

PharmExec

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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Activating Intent Data for Sales and Marketing

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.