Mon.Nov 04, 2024

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Ensuring Safety and Efficacy in the Cold Chain Space

Pharmaceutical Commerce

In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, explains why ultra-precise temperature control and customized logistics solutions are critical when it comes to biologics and personalized medicine.

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Northwestern and Case Western Reserve universities develop Huntington’s therapy

Pharmaceutical Technology

Researchers from Northwestern and Case Western Reserve universities have developed a polymer therapeutic to treat Huntington's disease.

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Empowering versatile applications of digital PCR with standardized, validated assays

Bio Pharma Dive

Bio-Rad’s extensive ddPCR assay offerings help researchers leverage the full power of digital PCR.

Research 237
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FDA grants fast track status to FELIQS’s FLQ-101 to prevent ROP

Pharmaceutical Technology

The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP).

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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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Centers of excellence or product-centric BizDevOps managed services?

Bio Pharma Dive

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

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November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application

Rethinking Clinical Trials

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a grant application for PCORI.

More Trending

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Injectables manufacturing ushers in a new era of accessibility

Pharmaceutical Technology

Increasingly, injectable manufacturers recognise that to achieve maximum profitability, they need to focus on the value they provide.

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Novo inks Ascendis deal to develop long-acting GLP-1, other metabolic drugs

Bio Pharma Dive

Per terms, Novo could pay up to $285 million in upfront and milestone fees to Ascendis, which specializes in a kind of drug-enhancing technology.

Drugs 182
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Disc teases potential NDA for rare skin disorder drug

Pharmaceutical Technology

In an end-of-Phase II meeting, the FDA indicated support for accelerated approval based on existing clinical data.

Drugs 130
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Neurogene secures $200M ahead of anticipated study readout

Bio Pharma Dive

The news led to a stock surge on expectations that forthcoming data for the company’s experimental gene therapy for Rett syndrome may turn out positive.

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

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Prokarium bolsters IP portfolio with two new US patents

Pharmaceutical Technology

UK-based biopharmaceutical company Prokarium has received two Notices of Allowance from the US Patent and Trademark Office.

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In defense of radioligand therapies, Novartis fired off patent lawsuits against Lilly and other rivals

Fierce Pharma

As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against its competitors. | As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against competitors.

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NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

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BioNTech reports surprising COVID vaccine sales in Q3 but tempers expectations for annual sales

Fierce Pharma

BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.

Sales 122
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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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Novo puts $285m into monthly GLP-1 based on Ascendis tech

pharmaphorum

Novo Nordisk puts $285m into a once-monthly GLP-1 agonist for obesity using technology developed by fellow Danish pharma Ascendis

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Journey Medical, with FDA nod, won't stop believing it can establish new rosacea standard of care

Fierce Pharma

Dermatology drugmaker Journey Medical has trekked its Dr. Reddy’s Laboratories-partnered rosacea med across the FDA finish line as Emrosi. | The drug proved superiority in clearing lesions over Galderma's standard-of-care Oracea capsules in phase 3 studies, leaving Journey to deploy its dermatology sales force to establish Emrosi as a dominant treatment.

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Accord will build £50m manufacturing plant in UK

pharmaphorum

Accord Healthcare unveils £50m investment, backed by the UK government, that will see a new manufacturing facility built in Newcastle

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Thermo Fisher integrates Labguru ELN for streamlined lab management

Outsourcing Pharma

Thermo Fisher Scientific has joined forces with Labguru to integrate Labguruâs Electronic Lab Notebook (ELN) into Thermo Fisherâs Laboratory Information Management System (LIMS) and lab operations software.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The AI effect in pharma commercial strategy: From data to real-time insight & actions

pharmaphorum

Discover how AI is transforming the pharma commercial strategy. Unlock real-time insights & actions from data. Click here for more.

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Incyte wins injunction to block launch of Sun Pharma's JAK inhibitor Leqselvi

Fierce Pharma

Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.

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NHS pilots iPhone app to rule out throat cancer

pharmaphorum

NHS England starts pilot trial of an iPhone app and device that could be used by nurses to speed up reviews of suspected throat cancer cases.

Nurses 110
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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Drug Channels

Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid ho

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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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Incyte blocks US launch of Sun Pharma's alopecia drug

pharmaphorum

US district court grants an injunction sought by Incyte on the launch of Sun Pharma's recently approved Leqselvi for alopecia areata

Drugs 110
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While Novo and Lilly's market value declined in Q3, BMS, Gilead and Sanofi surged: GlobalData

Fierce Pharma

While Eli Lilly and Novo Nordisk had market cap declines in the third quarter, Bristol Myers Squibb, Gilead Sciences and Sanofi saw their value increase, according to GlobalData.

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Medicare Part D: Navigating Plans and Potential Gaps in 2025

Pharmaceutical Commerce

With a 26% decline in prescription drug plans from 2024 to 2025, navigating potential gaps and accessing care remains vital for low income patients.

Drugs 52
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Nektar pads wallet with $90M manufacturing plant sale to Ampersand

Fierce Pharma

After a protracted rough patch—which has included layoffs, partnership terminations and lawsuits—San Francisco’s Nektar Therapeutics is extending its cash runway with the sale of one of its two mai | Nektar is selling its Huntsville, Alabama, manufacturing plant and reagent supply business to private equity firm Ampersand for a total value of $90 million.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Pharma Pulse 11/4/24: RWD Benefits in Privacy and Targeting, Challenges of Treating Type 1 Diabetes & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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ESSA Pharma Pulls Plug on Masofaniten Prostate Cancer Drug After Disappointing Trial Results Against Xtandi

XTalks

ESSA Pharma announced the discontinuation of its Phase II study on masofaniten, which it was evaluating for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The decision came after a futility analysis of data from the study indicated there was a low probability of achieving the prespecified primary endpoint. ESSA was evaluating the drug in a head-to-head study against Pfizer and Astellas’ blockbuster prostate cancer drug Xtandi (enzalutamide).

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Pharmas ask appeals court to reconsider IRA lawsuits

pharmaphorum

The pharma industry's challenge to Medicare drug price negotiation powers continues to rumble on, with three drugmakers asking a US appeals court to revive their lawsuits.Lawyers for AstraZeneca, Bristol-Myers Squibb, and Johnson & Johnson argued at a panel hearing in Philadelphia late last week that the negotiation powers – introduced as part of the Biden administration's Inflation Reduction Act (IRA) – infringe their constitutional rights.

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World Diabetes Day 2024: Advanced Care for Diabetes Management

XTalks

As we approach World Diabetes Day on November 14, this year’s theme , “Diabetes and Well-being,” underscores the need to support both physical and mental health in diabetes care. With over 537 million people affected globally, diabetes complications like cardiovascular disease, kidney failure and neuropathy are on the rise. Early diagnosis and proactive management are essential to reducing these risks.

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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.