Tue.Mar 18, 2025

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

By Sara W. Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

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How non-traditional investors fuel up-and-coming biotechs when VC funding dries up

PharmaVoice

Smaller biotechs are finding creative ways to fund R&D at a time when the traditional financing channels have become more constrictive.

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Duchenne patient dies after receiving Sarepta gene therapy

BioPharma Dive

A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.

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How to use Pay Per Click Advertising to Reach HCPs in Pharma

Pharma Marketing Network

Introduction Reaching healthcare professionals (HCPs) in the pharmaceutical industry has become increasingly challenging due to strict regulations, evolving digital landscapes, and the growing demand for personalized content. However, pay per click advertising (PPC) presents a powerful and targeted solution for pharma marketers looking to engage HCPs efficiently.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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AstraZeneca and Alteogen agree on ALT-B4 platform tech

Pharmaceutical Technology

AstraZeneca has entered an exclusive licence agreement with Alteogen involving the latters ALT-B4 platform technology.

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More Trending

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UKHSA announces new effort to tackle hepatitis C

Pharma Times

The agency has launched a whole genome sequencing service to monitor the virus

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NHS medicines spending in England in greater focus

pharmaphorum

Stay informed about the latest information on NHS medicines spending in England, with a greater focus on the data provided by the NHS Business Services Authority (NHBSSA).

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Prime sets sights on liver, lung disease as next target for its gene editing tech

BioPharma Dive

The biotech unveiled a new research program in alpha-1 antitrypsin deficiency, a disease that’s also a focus for rival Beam Therapeutics.

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Novo Nordisk returns to ABPI fold after two-year suspension

pharmaphorum

Novo Nordisk has reached the end of its two-year suspension from the ABPI for breaches of its code of practice after making "sustained improvements"

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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 approves Biogen’s Skyclarys for Friedreich’s ataxia

Pharmaceutical Technology

Health Canada has granted approval for Biogens Skyclarys to treat Friedreichs ataxia (FA) in individuals aged 16 years and above.

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Sofinnova closes new fund and backs a trio of new biotechs

pharmaphorum

Sofinnova Partners has raised 165m for its new biotech fund and backed three startups working on Alzheimer's, fibrotic diseases, and cell therapies

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Big tech meets biotech: Recursion and the AI gold rush in pharma 

Pharmaceutical Technology

The use of AI in drug discovery and development has been recognised, explored, and implemented throughout the last decade, with a notable acceleration in recent years.

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Arbor raises $74M amid genetic medicine’s funding slump

BioPharma Dive

The round will fund a “one-and-done” treatment for a rare kidney condition that its CEO says can address concerns patients have with therapies from Alnylam and Novo Nordisk.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Does Compounding Make Sense for Your Pharmacy?

PioneerRx

Out of the approximately 56,000 community pharmacies in the U.S., about 7,500 pharmacies specialize in compounding services and that number is only expected.

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AstraZeneca buys cell therapy biotech for up to $1bn

pharmaphorum

AstraZeneca plans to acquire Belgian in vivo cell therapy biotech EsoBiotec and has signed a pair of licensing deals with drug delivery firm Alteogen.

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Access USA 2025: This Year’s State of the Industry

Pharmaceutical Commerce

The conferences opening session highlights the sectors current landscape of healthcare coverage and access.

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Vertanical's cannabis-based painkiller hits target in trials

pharmaphorum

A cannabis-derived drug developed by Vertanical has shown efficacy in phase 3 for chronic back pain and could reach its first markets soon

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Opko and Entera focus on oral care for obesity and metabolic disorders

Pharmaceutical Technology

Opko Health and Entera Bio have announced a partnership and licence agreement to progress the development of oral dual agonist GLP-1.

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EnteroBiotix cues up larger trial of microbiome IBS therapy

pharmaphorum

EnteroBiotix has reported phase 2a proof-of-concept data for its therapy for irritable bowel syndrome (IBS) based on gut microbiome species

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Sofinnova’s latest biotech fund sprouts three new startups

BioPharma Dive

As part of its “pan-European” plans, Sofinnova is backing startups developing treatments for fibrosis, cancer and Alzheimer’s.

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Study Explores Effectiveness of HTD1801 in Type 2 Diabetes

Pharmacy Times

Treatment with HTD1801 resulted in significant reductions in the hemoglobin A1c level and improved key cardiometabolic and liver parameters.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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DCAT Week 2025: Expanding Sterile Injectables Capacity

PharmaTech

PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.

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The faster horses fallacy: Why true innovation starts with customer insight

pharmaphorum

Learn why true innovation requires more than just improving existing products or services. Discover how customer insight and a focus on the healthcare industry can drive truly groundbreaking innovations.

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DCAT Week 2025: Impact of Geopolitical Climate on Biopharma

PharmaTech

PharmTech sat down with Joseph Principe, chief commercial officer at Abzena ahead of DCAT Week 2025 to get his perspective on how the geopolitical climate is impacting the industry.

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How Pharma Leaders Can Secure Supply Chains

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDOs national life sciences co-leader, outlines the ways that tariffs disrupt pharma supply chains, along with how leaders can evaluate and prepare for the resulting challenges.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.