October, 2023

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Clinical trial disparities and how to build a more inclusive future

pharmaphorum

Clinical trial disparities and how to build a more inclusive future Mike.

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Opinion: How AI Can Accelerate and Improve Clinical Trial Recruitment

BioSpace

New platforms are emerging to help biopharma companies fill their human studies more efficiently, but barriers remain to their successful implementation.

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On a journey to diverse, inclusive, and more efficient rare disease trials

pharmaphorum

On a journey to diverse, inclusive, and more efficient rare disease trials Mike.

Trials 117
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FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death

BioSpace

The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.

Antibody 115
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Health Literacy Month: How industry communication can impact patient health literacy

Antidote

Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.

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Evolving with the patient: Optimising CAGT post-trial long-term follow-up

pharmaphorum

Evolving with the patient: Optimising CAGT post-trial long-term follow-up Mike.

Trials 115

More Trending

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

Sales 145
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Parkinson’s Research Buoyed by Alzheimer’s Advances

BioSpace

After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.

Research 142
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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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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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CAR-TCR 2023 – Matt Lakelin

pharmaphorum

At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.

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A decade later, biotech’s CRISPR revolution is still going strong

Bio Pharma Dive

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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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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Relay Therapeutics Pauses Lirafugratinib Rare Cancer Plans Due to IRA

BioSpace

The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.

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Understanding primary sclerosing cholangitis symptoms

Antidote

Primary sclerosing cholangitis (PSC) is an autoimmune disease that mainly targets bile ducts in the liver. PSC is a rare condition, impacting about 1 in 10,000 people worldwide , and it is diagnosed twice as frequently in men as it is in women.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

Radiology 119
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Verve gets FDA green light to run base editing study in US

Bio Pharma Dive

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

In-Vivo 341
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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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Lisata receives orphan drug designation for pancreatic cancer therapy

Pharmaceutical Technology

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

Drugs 286
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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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NASH on the Cusp: An Emerging Market Opportunity

BioSpace

The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.

Marketing 130
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Local authorities in England are failing to meet dementia diagnosis targets

Pharma Times

The APPG has called for urgent improvements in rural and ethnically diverse-areas - News - PharmaTimes

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Podcast: The British start-up taking psychedelic therapy mainstream

BioPharma Reporter

In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.

Medicine 119
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Pfizer to cut costs, lay off staff on waning demand for COVID products

Bio Pharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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Empowering patients: How to match to clinical trials

Antidote

Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.

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As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

Sales 140
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease

BioSpace

While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.

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UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

Research 148
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Focussing on finding value in health sciences marketing

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with life sciences advisor Randall Hein, CEO of Heinsight LLC, and health sciences marketing expert Krystle Buntemeyer, CEO of SCORR Marketing, about the trends and changes for health sciences marketing over the past few years.

Marketing 116
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Vertex, CRISPR therapy for sickle cell passes FDA panel test

Bio Pharma Dive

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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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