Thu.Apr 11, 2024

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DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.

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UK’s NICE recommends AbbVie’s Aquipta to treat migraines

Pharmaceutical Technology

The oral drug, which gained UK approval in September 2023, is used for the prevention of both chronic and episodic migraines.

Drugs 244
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US sues Regeneron, alleging false price reporting on Eylea

Bio Pharma Dive

The lawsuit claims the drugmaker didn’t disclose reimbursement to drug distributors for credit card fees, artificially inflating the reported price of the blockbuster eye drug.

Drugs 189
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Radical Vaccine Strategy Could Help Quash Parasite Afflicting Millions

AuroBlog - Aurous Healthcare Clinical Trials blog

Using viruses that infect bacteria to detect proteins sprouted by a notorious parasite, scientists have honed in on possible vaccine targets for schistosomiasis, a neglected tropical disease that currently affects an estimated 600 million people worldwide, causing 280,000 deaths per year.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Century buys a startup, raises funding in cell therapy expansion

Bio Pharma Dive

The biotech is acquiring Clade Therapeutics and its stem cell technology at a discount price, while adding $60 million via a private placement led by Bain Capital.

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Drug delivery innovations push forth women’s health

Pharmaceutical Technology

From nanoparticles to transdermal patches, Pharmaceutical Technology takes a look at the latest in drug delivery technologies for women's health.

More Trending

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Surges in obesity drugs forecast to enter US market

Pharmaceutical Technology

Over the past two decades, there has been a marked increase in obesity rates among US adults, with projections indicating a continuing upward trend.

Marketing 130
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FDA commissioner tells lawmakers his agency needs more authority to prevent drug shortages

Fierce Pharma

After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., told lawmakers that the agency, as the "referee," needs to be given more authority in order to preemptively halt drug shortages.

Drugs 123
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Pharmaceutical filtration and purification solutions for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical Technology has listed the leading suppliers of pharmaceutical filtration equipment and purification solutions. Download here.

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US Drug Shortages Reach All-Time High Since 2001: Report

BioSpace

The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.

Drugs 123
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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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Rallybio and J&J collaborate to tackle maternal-foetal blood disorder

Pharmaceutical Technology

The collaboration pact will see Rallybio gaining a $6.6m equity investment from J&J to further a natural history study of FNAIT.

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How to overcome hurdles to HCP and patient adoption of digital health initiatives

pharmaphorum

Discover effective strategies to overcome barriers to healthcare providers (HCP) and patients adopting digital health initiatives like apps. Learn how to increase engagement and improve outcomes.

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Vertex joins pharma immunotherapy deal uptick with $4.9bn Alpine purchase

Pharmaceutical Technology

Alpine’s lead asset, povetacicept, is slated to enter Phase III trials in the second half of this year.

Trials 147
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Regeneron hit with DOJ complaint that it hid 'hundreds of millions' in Eylea credit card processing fees from Medicare

Fierce Pharma

The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea. | The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea.

Drugs 118
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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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OSE wins French govt grant for Phase III trial for cancer vaccine

Pharmaceutical Technology

The $9m French funding is for Phase III registrational trial for OSE’s Tedopi as a second-line treatment for NSCLC.

Trials 130
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Eli Lilly under pressure: Can they solve GLP-1 supply squeeze?

BioPharma Reporter

Specific doses of Eli Lillyâs GLP-1 blockbuster drugs Mounjaro and Zepbound are currently facing a supply shortage, and frustrated patients are urging the pharma giant to act â fast.

Drugs 119
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Addressing key challenges in HPAPI manufacturing

Pharmaceutical Technology

With specialised production facilities for HPAPIs in great demand, what are the key challenges in manufacturing?

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Vertex Buys Alpine for $4.9B to Bolster Autoimmune and Inflammatory Disease Pipeline

BioSpace

Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.

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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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Green shoots and cautious optimism: Insights from BIO-Europe Spring

pharmaphorum

Discover the latest insights and trends from BIO-Europe Spring conference, focusing on green shoots and cautious optimism in the industry. Learn about the latest funding opportunities and more.

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Vaccines, Next-Gen Approaches Target the Toughest Cancers: AACR

BioSpace

Data presented the American Association for Cancer Research’s annual meeting sparked hope that we could be getting closer to treating pancreatic cancer, glioblastoma and other particularly difficult tumors.

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In Alzheimer’s Dementia, Should EEG Be Used as a Functional Biomarker of Target Engagement and Organizational Change When Evaluating Treatment Efficacy?

XTalks

Approaches to help better understand the complexities of brain function are key to advancing the development of novel treatments for Alzheimer’s disease. In recent years, researchers have increasingly recognized the value of biomarkers in Alzheimer’s disease in several areas, including offering biological insights into the disease’s pathophysiology, developing diagnostic tools for earlier disease detection, monitoring disease progression and evaluating the efficacy of new treatments.

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Moderna Halts Plans for Kenyan mRNA Vaccine Plant After Taking $1B Financial Hit

BioSpace

Moderna Thursday said it paused plans to build an mRNA manufacturing facility in Kenya to buy time to assess vaccine demand after being hit with $1 billion in losses and write-downs due to canceled orders.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Researchers call to reduce repeat antibiotic prescriptions for respiratory tract infections

Pharma Times

RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR

Research 146
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Amylyx Plots New Path in Rare Genetic Disease After Relyvrio Withdrawal

BioSpace

On the heels of withdrawing Relyvrio from the U.S. and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035.

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Pfizer settles 12-year-old lawsuit in alleged pay-for-delay scheme for $39M

Fierce Pharma

In a case so old that it predates Pfizer’s 2009 acquisition of Wyeth, the companies and a class-action group of direct drug purchasers have agreed to

Drugs 115
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DOJ Sues Regeneron for Allegedly Inflating Medicare Pricing for Eye Drug Eylea

BioSpace

The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.

Drugs 107
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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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Novartis adds clinical-stage protein degrader from Arvinas

pharmaphorum

Novartis accelerates its protein degrader programmes by licensing a phase 3-ready prostate cancer candidate from Arvinas in a deal worth over $1 billion

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Innovative Financing Models for Repurposing Generic Drugs

Drug Patent Watch

A paper presented at the 2nd International Conference on Systems Medicine, AI, and Drug Repurposing proposes a novel approach to overcoming the financial barriers associated with repurposing generic drugs through… Source

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EU pharma reform package clears key Parliament vote

pharmaphorum

The European Parliament has voted through reforms to legislation regulating the pharma sector, which the industry claims could compromise competitiveness and patient care.

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UK study finds screening with a PSA test in prostate cancer can lead to overdiagnosis

Pharma Times

Prostate cancer is responsible for around 12,000 deaths a year in the UK and is the second biggest cause of death for men

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.