Sat.Nov 18, 2023 - Fri.Nov 24, 2023

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The rare disease treatment revolution: Pioneering patient-centric transformation in pharmaceutical customer engagement

pharmaphorum

The rare disease treatment revolution: Pioneering patient-centric transformation in pharmaceutical customer engagement Mike.

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Treehill Partners’ Ali Pashazadeh on How to Improve Clinical Trial Design

BioSpace

After reviewing the outcomes of 1,200 clinical studies, the firm says it can help most biopharmas set their trials up for success while cutting costs in half.

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Demystifying Patient Advocacy in Clinical Research

XTalks

Today’s healthcare landscape is rapidly shifting, with an emphasis on the need for patient-centered care. Xtalks’ recent discussion with Rebekah Angove, PhD, Executive VP of Research and Evaluation at the Patient Advocate Foundation (PAF), offers a deeper understanding of incorporating patient narratives into clinical trials. Established over 25 years ago, the PAF has been dedicated to providing direct services to patients experiencing access and affordability challenges, especially those with c

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5 Cancer Vaccines to Watch in 2024

BioSpace

BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.

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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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How Worldwide and Every Cure Are Using AI To Unlock New Rare Disease Treatments

Worldwide Clinical Trials

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. We recently partnered with Every Cure , a nonprofit organization, to help them advance their mission of unlocking the full potential of every existing medicine to treat as many diseases as possible — with a specific focus on rare diseases.

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The Next Generation of Weight Loss Drugs is Rapidly Approaching

BioSpace

Successful drugs from Novo Nordisk and Eli Lilly are just the beginning of what one analyst says could be “the largest therapeutic class of drugs that the biopharma industry has ever seen.

Drugs 114

More Trending

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Roche’s Genentech partners with Nvidia in AI drug deal

Bio Pharma Dive

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

Drugs 321
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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. The pivotal proof-of-concept testing clears the way to progress the Clamp2 technology in a range of research programmes. Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s wi

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Drugs 353
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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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Quotient emerges from Flagship with plan to explore somatic mutations

Bio Pharma Dive

Studying somatic mutations could be “the next wave of opportunity” to develop more precise medicines, said Mike Stratton, one of Quotient’s scientific co-founders.

Medicine 275
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To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

Fierce Pharma

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victo | Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic.

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Food Industry Influencers Warned by FTC for Inadequate Disclosure of Paid Promotions

XTalks

Food industry influencers were recently at the center of a controversy highlighted by the Federal Trade Commission (FTC). Last week, the FTC issued warning letters to two major groups in the food and beverage sector and several online food industry influencers. Their offense? Inadequate disclosure of paid social media posts that endorsed a sweetener and various sugary products.

Marketing 110
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Health Canada approves Jazz’s cannabis derived seizure therapy

Pharmaceutical Technology

Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.

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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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Flagship-backed microbiome biotech Evelo to shut down

Bio Pharma Dive

The company said it had not found “a viable alternative” to closing down in the months since it hit a clinical setback and laid off staff.

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Pfizer's cost-savings mission continues with office shuffle, job cuts in Ireland

Fierce Pharma

Pfizer, working through a $3.5 billion cost-cutting drive, is not done yet making changes to its workforce in Ireland. | Pfizer's commercial office in Citywest, Dublin, will move to its Ringsend office building, the Irish Independent reports. The moves could end in more job cuts in the company's commercial division.

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Flagship-Founded Microbiome Company Evelo Biosciences Throws in the Towel

BioSpace

In an SEC filing, the biotech launched by Flagship Pioneering said there was no viable alternative to dissolution as its cash ran out and anti-inflammatory assets failed to achieve clinical success.

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Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

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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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AstraZeneca creates digital health unit, with big-name partnerships already in place

Bio Pharma Dive

Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

Marketing 291
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Texas accuses Pfizer and contract manufacturer of providing ineffective ADHD drug to state's Medicaid program

Fierce Pharma

Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR. The lawsuit further accuses the companies of manipulating quality-control testing from 2012 to 2018 to ensure samples received passing grades.

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BHF and UKDRI announce first UK centre for vascular dementia research

Pharma Times

The centre will help discover new treatments to prevent, halt and cure the condition - News - PharmaTimes

Research 133
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Takeda wins EU approval for paediatric use of Takhzyro in HAE

Pharmaceutical Technology

Takhzyro has been approved for the routine prevention of recurrent hereditary angioedema attacks in patients aged 2 years and older.

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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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Bristol Myers faces FDA delay on cancer cell therapy decision

Bio Pharma Dive

The regulator plans to convene an advisory panel to discuss an expanded indication for Abecma, presenting another hurdle for Bristol Myers and partner 2seventy bio.

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With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma's patent tactics

Fierce Pharma

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. | The U.S. Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process. And it's Sanofi’s turn to land in the crosshairs.

Insulin 116
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Two charities co-fund £5.5m childhood cancer research programme

Pharma Times

SMPaeds2 aims to advance precision medicines for children with relapsed cancer - News - PharmaTimes

Research 135
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Signal: Moderna mRNA patent revoked by EPO after Pfizer suit

Pharmaceutical Technology

Pfizer and BioNTech countersued Moderna following an initial August 2022 suit alleging that its patents were overly broad.

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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.

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Medtronic CEO downplays impact of obesity drugs on procedures, devices

Bio Pharma Dive

Surging demand for GLP-1 agonists has put medtech firms like Medtronic under pressure, even as they argue the hit to their businesses will be minimal.

Drugs 269
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GSK aims to slash carbon emissions with next-generation inhaler

Fierce Pharma

Joining drugmakers like AstraZeneca and Novo Nordisk, GSK is making big strides in its quest to clean up its carbon footprint. | GSK plans to start late-stage trials of a low-carbon version of its metered dose inhaler (MDI) Ventolin utilizing a next-generation propellant in 2024. If the new product proves successful, it has the potential to slash greenhouse gas emissions from Ventolin use by roughly 90%.

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Food Deflation Anticipated: Walmart CEO Foresees Price Drops

XTalks

Walmart’s president and CEO, Douglas McMillon, foresees an upcoming phase of food deflation in the US. He expressed this during an earnings call last week, saying that he’s expecting “a period of deflation in the months to come,” adding, “While that would put more unit pressure on us, we welcome it because it’s better for our customers.” He mentioned that although beef prices remain high, there has been a noticeable decrease in the cost of eggs, dairy, chicken and seafood.

Sales 105
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Bayer expands German manufacturing facilities to fulfill supply demand

Pharmaceutical Technology

Bayer announced the launch of a Berlin, Germany-based manufacturing facility to meet future demands from the US, China and Europe.

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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.