Sat.Oct 05, 2024 - Fri.Oct 11, 2024

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Judo Bio debuts with $100M and a plan to take RNA drugs to the kidney

Bio Pharma Dive

The Cambridge, Massachusetts-based biotech is using what it calls ligand-siRNA conjugates to reach drug targets in the kidney, which historically have been difficult to reach with RNA therapies.

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Deltaclinical is participating Bio Japan from 9 – 11 OCT.

Deltaclinical

Would you like to learn more about our services? Visit us at booth C-24. We are happy to welcome you! But first, our CEO Geert Briers will attend the EU-Japan center conference in Osaka from 7 – 8 OCT.

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Health Canada approves Telix’s Illuccix label expansion

Pharmaceutical Technology

Health Canada has expanded the approved use of Telix Pharmaceuticals' Illuccix for patient selection in PSMA targeted radionuclide therapy.

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Mpox shows need for new approaches to therapeutic antibody research

pharmaphorum

The recent Mpox outbreak highlights the urgent need for new approaches to therapeutic antibody research. Discover how the World Health Organization (WHO) and CDC are responding to this public health crisis.

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

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Intellia starts late-stage test of CRISPR therapy for rare swelling disease

Bio Pharma Dive

The study, of Intellia’s treatment for hereditary angioedema, is the second Phase 3 trial the biotech has begun testing its “in vivo” gene editing medicines.

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North American biotech innovation: Who and where?

Drug Discovery World

DDW’s Diana Spencer explores some of North America’s most important life science hubs and finds out the benefits of each unique ecosystem. The United States dominates the biotech sector in North America and globally, with an estimated value share of nearly 59% in 2021 1. According to Key Biotechnology Indicators collated by the Organisation for Economic Co-operation and Development (OECD), the country had the largest number of biotechnology firms in 2021 with 2,840 2 , though some sources say th

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NHS England to be given a bigger role in GP data sharing

pharmaphorum

UK Health Secretary Wes Streeting has announced plans to allow NHS England to share primary care data with scientific researchers, taking on some of the responsibility held by GPs. The minister told the Royal College of General Practitioners (RCGP) annual conference that, while many UK patients have given their consent for their data to be shared with studies run by the likes of the UK Biobank, Genomics England, and Our Future Health, they "still see, far too often, that this data is not shared

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Scholar Rock scores with ‘surprise’ success in SMA drug study

Bio Pharma Dive

Phase 3 findings could position the biotech’s therapy to become part of a “new standard” for SMA, its CEO said, while boosting research into whether it can preserve muscle in people with obesity.

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Drug Patent Expirations for the Week of October 6, 2024

Drug Patent Watch

NUCYNTA ER (tapentadol hydrochloride) Collegium pharm inc Patent: 8,114,383 Expiration: Oct 10, 2024 See More … Source

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EMA starts review into hair loss drugs about potential link to suicidal thoughts 

Pharmaceutical Technology

The safety review was requested by the French medicines agency, citing new safety reports that alter the risk profile of finasteride.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Activist investor Starboard builds $1bn Pfizer stake

pharmaphorum

Activist investor Starboard Value has amassed a $1bn stake in pharma group Pfizer and wants strategic changes to restore growth

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Best practices for developing safety profiles in rare disease trials

Bio Pharma Dive

The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.

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Amid GLP-1 craze, Novo and Mylan ink patent settlement in Ozempic case

Fierce Pharma

With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S. launch of their generic to Novo Nordisk's wildly popular Type 2 diabetes drug Ozempic. | Mylan Pharmaceuticals and Novo Nordisk have reached a confidential settlement in a patent lawsuit tied to generic Ozempic, also known as semaglutide, India’s Natco Pharma said.

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Oncolytics targets accelerated approval for oncolytic virus therapy

Pharmaceutical Technology

The company intends to start a registrational Phase II trial of pelareorep and chemotherapy combination for breast cancer in 2025.

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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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AZ extends cardiovascular pipeline with $2bn CSPC deal

pharmaphorum

AstraZeneca pays $100m upfront for rights to an oral lipoprotein(a) drug developed by Chinese biotech CSPC Pharmaceutical.

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An effective analytical testing strategy for viral vectors should include these 7 steps

Bio Pharma Dive

Producing safe, effective, high-quality viral vector therapeutics depends on a robust and tailored analytical testing strategy.

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In long-acting HIV PrEP access showdown with Gilead, GSK moves to triple Apretude supply for certain countries

Fierce Pharma

GSK’s ViiV healthcare unit is countering rival HIV drugmaker Gilead’s recent global access moves with its own pledge to make at least 2 million doses of its long-acting pre-exposure prophylaxis (Pr | The long-acting HIV PrEP maker pledged to make at least 2 million more doses available for low-and middle-income countries in 2025 and 2026.

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Activist investor Starboard forges $1bn stake in Pfizer to swing profits

Pharmaceutical Technology

US hedge fund Starboard now holds 0.6% of Pfizer’s value as the drugmaker struggles with its post-pandemic financial performance.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Enhancing Scalability and Quality of 3D In Vitro Cell Models Production through Automation

Drug Discovery World

In this Case Study, InSphero, a Swiss-based company specialising in 3D in vitro cell models and cell culture tools for drug discovery, describes: The advantages of 3D in vitro cell models for drug discovery The automation of the production of 3D in vitro cell models via InSphero’s Akura™ technology The benefits of InSphero’s Akura™ technology and Hamilton’s pipetting technologies The post Enhancing Scalability and Quality of 3D In Vitro Cell Models Production through Automation appeared first on

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How AI Makes the Voice of the Consumer Louder

Intouch Solutions

How does your organization make marketing decisions? Artificial intelligence (AI) is revolutionizing the way pharmaceutical companies make marketing decisions, and EVERSANA INTOUCH is at the forefront of this transformation. In this POV, John Kenny, EVP and Head of Strategic Planning, delves into the innovative use of AI-powered personas to keep the customer’s perspective central in marketing strategies.

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How Is Prospective Data Differentiating Real-World Evidence (RWE)?

XTalks

Real-world evidence (RWE) is gaining increasing interest in the pharmaceutical industry, particularly in enhancing drug approval processes and optimizing clinical trial designs. Kelly Brassil, PhD, RN, FAAN Senior Director, Business Development Pack Health, a Quest Diagnostics company RWE is being used to expand drug labels to include broader patient populations often underrepresented in traditional studies.

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NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia

Pharmaceutical Technology

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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How can automation improve 3D in vitro cell model production?

Drug Discovery World

Download this new Case Study from Hamilton and InSphero, entitled ‘ Enhancing Scalability and Quality of 3D In Vitro Cell Models Production through Automation ‘ In this Case Study, InSphero, a Swiss-based company specialising in 3D in vitro cell models and cell culture tools for drug discovery, describes: The advantages of 3D in vitro cell models for drug discovery The automation of the production of 3D in vitro cell models via InSphero’s Akura technology The benefits of InSphero’s A

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KOL Collaboration Series: Expanding Pharmacies’ Scope of Practice

Pharmaceutical Commerce

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Jenni Zilka, SVP, community & specialty pharmacy and president, Good Neighbor Pharmacy, explains how pending legislation can improve patient access, and how these are helping with recognizing pharmacists as HCPs.

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Kaléo unveils 58 layoffs days after pledging to double in-office commercial team for EpiPen rival Auvi-Q

Fierce Pharma

After Kaléo unveiled a “redesign” of the in-office commercial team for its EpiPen rival Auvi-Q at the start of the month, the privately held company has announced a fresh round of job cuts in the U | After Kaléo unveiled a “redesign” of the in-office commercial team for its EpiPen rival Auvi-Q at the start of the month, the privately held company has announced a fresh round of job cuts across the U.S.

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OnKure and Reneo Pharmaceuticals complete merger

Pharmaceutical Technology

OnKure has announced the successful completion of its merger with Reneo Pharmaceuticals, forming the combined entity

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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EU approves first new treatment for rare liver disease in a decade

Drug Discovery World

The European Commission has conditionally approved Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). The approval is limited to adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that exerts an effect on the proteins PPARα and PPARδ, thought to be key regulators of bile

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Informa Connect’s PBM Contracting Summit

Drug Channels

Informa Connect’s PBM Contracting Summit December 10-11, 2024 | Chicago, IL Drug Channels readers save 10% with code 24DRCH10 * Experts from across the US come together each year at the PBM Contracting Summit to gain innovative and practical contracting strategies, master PBM innovation and design, improve patient care management and rising costs, understand the current legislative issues impacting contract negotiations and more.

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Advancements in early detection and innovative therapies targeting tau pathology

pharmaphorum

Stay updated on the latest advancements in early detection and innovative therapies targeting tau pathology in Alzheimer’s disease. Learn more about the cutting-edge research and treatments available.

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ProductLife boosts drug development with IntiQuan acquisition

Pharmaceutical Technology

ProductLife Group (PLG) has announced the acquisition of IntiQuan, a Swiss firm specialising in pharmacometrics.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.