Tue.Jul 30, 2024

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Pfizer quits Duchenne gene therapy, lays off staff following study setback

Bio Pharma Dive

The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.

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GSK and Flagship Pioneering link for new medicines and vaccines

Pharmaceutical Technology

GSK has announced a strategic collaboration with Flagship Pioneering for the discovery and development of medicines and vaccines.

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Ancient Genes of Zombie Viruses Revealed as Hidden Drivers of Cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

When viruses pay us a visit, they sometimes leave parts of themselves behind. Silently tucked away in our genomes, some of these bits of foreign DNA can get passed down through the generations.

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Study finds semaglutide decreases tobacco-related healthcare

Pharmaceutical Technology

Semaglutide, marketed as Ozempic and Wegovy, decreased tobacco-related healthcare encounters compared to other medications.

Marketing 245
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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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Pfizer’s Bourla confident in company’s obesity drug position, despite delays

Bio Pharma Dive

The CEO noted how Pfizer's danuglipron could still be the second oral GLP-1 treatment to enter registrational tests after Lilly's orforglipron.

Drugs 200
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July 30, 2024: Save the Date: Meet HCRSN in St. Louis for the 2025 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) will hold its 2025 Annual Conference from April 8 to 10, 2025, in St. Louis, Missouri. HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of learning healthcare systems.

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Talk of the Towne episode 11: American Kidney Fund

Antidote

In the latest installment of Talk of the Towne, we sat down with Melanie Paris, M.A., MPH, the Senior Director of Strategic Partnerships and Kidney Disease Education at the American Kidney Fund (AKF). In the discussion, we got her insights into the types of kidney disease, treatment disparities, and the importance of clinical research in the field. She also shared many valuable resources for individuals and their loved ones living with kidney disease, which are linked here.

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FDA grants priority review for Novartis’ leukaemia treatment

Pharmaceutical Technology

The US FDA has granted priority review designation for Novartis’ Scemblix for Ph-positive chronic myeloid leukemia in the chronic phase.

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Incyte trims cancer drug pipeline in R&D refocus

Bio Pharma Dive

The company will stop developing five experimental treatments, including two oral checkpoint inhibitors targeting PD-L1.

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Collegium buys Ironshore for $525m and enter ADHD market

Pharmaceutical Technology

Collegium will pay $525m upfront to add Ironshore’s FDA-approved ADHD medication Jornay PM to its portfolio.

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

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A symbiotic relationship for optimal AI-powered healthcare

pharmaphorum

Discover how OPEN Health and fusion's AI technology partnership is creating a symbiotic relationship that is revolutionising healthcare. Explore the benefits of this for optimal patient care.

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Biotech IPO raising in Q1 2024 surged from Q4 2023 – but has the momentum lasted?

Pharmaceutical Technology

Biotech IPOs surged in Q1 2024, with eight completed IPOs raising a total of $3.72bn, six times more than the $621m raised in Q4 2023.

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5 cybersecurity guidelines for remote monitoring in clinical trials

pharmaphorum

Implementing strong cybersecurity guidelines for remote monitoring in clinical trials is crucial to protect sensitive data. Learn these top 5 guidelines to secure your remote monitoring plan effectively.

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NICE not to recommend Daiichi Sankyo-AstraZeneca’s Enhertu for NHS

Pharmaceutical Technology

The UK NICE has decided not to recommend Daiichi Sankyo and AstraZeneca’s Enhertu for advanced HER2-low breast cancer for NHS use.

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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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Pfizer tacks on $1B to 2024 revenue outlook amid cost-cutting drive

Fierce Pharma

For more than a year after Pfizer’s COVID product sales peaked at the end of 2022, the company’s quarterly revenues showed year-over-year declines. | For the first time since its sales peaked during the pandemic, Pfizer registered year-over-year revenue growth during the second quarter of 2024. And while the busy has been busy trimming operating expenses, it did add $1 billion to its total revenue projection for the year.

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Boehringer Ingelheim acquires Nerio Therapeutics for $1.3bn

Pharmaceutical Technology

Boehringer Ingelheim has acquired Nerio Therapeutics, a drug discovery and development company, in a deal valued at $1.3bn.

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Approaching the regulatory world with passion: CERs and EU MDR processes

pharmaphorum

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Ethan Drower, co-founder and CEO of Cite Medical Solutions, a company providing full Clinical Evaluation Report (CER) services and industry literature review for European Union Medical Device Regulation (or EU MDR) processes.

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Cybersecurity in clinical trials: safeguarding patient data against digital breaches

Pharmaceutical Technology

Trials and their partners need to adopt a strong cybersecurity strategy to protect sensitive patient data from hackers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BioNTech cancer vaccine hits the spot in melanoma

pharmaphorum

mRNA specialist BioNTech has chalked up an important win in its cancer pipeline, showing efficacy with its BNT111 vaccine candidate in a phase 2 trial in advanced melanoma.The study is looking at the combination of BNT111 with Regeneron's PD-1 inhibitor Libtayo (cemiplimab) in 184 patients with advanced melanoma who have relapsed after or not responded to treatment with a PD-1/PD-L1 inhibitor, or the two therapies given alone.

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Roche’s Vabysmo challenges Eylea dominance with third European indication

Pharmaceutical Technology

The European Commission (EC) has approved Vabysmo (faricimab) for the treatment of retinal vein occlusion.

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Circular RNA Will Soon Replace mRNA in Biopharma

BioSpace

The advantages of using circular RNAs—including increased durability, enhanced protein expression, and substantially lower manufacturing costs compared to linear mRNAs—have driven a spate of investment in this technology.

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Salmonella Control: Comparing US and EU Regulations for Poultry

XTalks

Salmonella control in poultry in the US has come under intense regulatory scrutiny over the past few years. With increasing concerns about food safety, it might be worth considering whether the US should adopt the European Union’s (EU) regulatory mindset. The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) declared Salmonella an adulterant in raw breaded stuffed chicken products when contamination levels exceed one colony-forming unit (CFU) per gram.

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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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Sanofi sues Sarepta, claiming Duchenne gene therapy Elevidys infringes 2 manufacturing patents

Fierce Pharma

Six months after surviving a patent challenge involving its $3.2 million gene therapy, Sarepta faces a new lawsuit from another gene therapy developer claiming the approved treatment infringes its | Six months after surviving a patent challenge involving its $3.2 million gene therapy, Sarepta faces a new lawsuit from another gene therapy developer claiming the approved treatment infringes active patents.

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Older GLP-1 drug shows glimmer of benefit in Alzheimer's

pharmaphorum

A small study of Novo Nordisk's once-daily injectable GLP-1 agonist liraglutide shows a benefit in patients with Alzheimer's disease

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Explore how Lonza's experts tackle parenteral drug and bioconjugate development challenges

BioPharma Reporter

In the rapidly evolving field of pharmaceuticals, the development of parenteral drugs and bioconjugates presents unique challenges and opportunities.

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Benefits of Drug Patent Licensing Agreements

Drug Patent Watch

The Power of Patent Licensing: Unlocking Innovation and Access to Medicines Patent licensing agreements have become a crucial tool in the pharmaceutical industry, allowing companies to collaborate and…

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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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Women in Science - Tehmina Masud - the importance of growing outside your comfort zone

BioPharma Reporter

A book, a computer and some sage words from her physicist father set Tehmina on her path to a successful career in science.

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Cognition's SHINE data for Alzheimer's drug dulls prospects

pharmaphorum

Cognition Therapeutics has reported phase 2 data with its Alzheimer's disease candidate, claiming the results show proof-of-concept for the drug, although the study missed its main endpoint.Cognition's stock lost more than 40% of its value in trading after the data was presented yesterday, and slipped another 20% after hours, despite assertions by the New York biotech that its CT182 drug showed "consistent" improvements in cognitive outcomes compared to placebo in the SHINE study.

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From Eli Lilly to Entrepreneur: A Journey to Independent Consulting

BioSpace

After more than 20 years at Eli Lilly, Leslie Sam moved into independent consulting. To prepare for the transition, she focused on becoming technically deep and earning industry recognition.

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HDR UK and DPUK granted £2m for new motor neurone disease research initiative

Pharma Times

The rapidly progressive neurological condition affects around 5,000 people in the UK

Research 101
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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.