Tue.Feb 04, 2025

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February 4, 2025: Workshop Summary Now Available for ‘Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues’

Rethinking Clinical Trials

A workshop summary, videocast recordings, and other materials are now available from the NIH Pragmatic Trials Collaboratory’s 2024 virtual workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.

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Thermo Fisher continues viral vector withdrawal; lays off 300 employees

Pharmaceutical Technology

The cuts at two Massachusetts plants follow further site closures and layoffs across the company over the past few years.

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Dangerous Kind of Fat Hidden in The Body Can Raise Your Risk of Death

AuroBlog - Aurous Healthcare Clinical Trials blog

(Peathegee Inc/Getty Images) Humans with relatively more fat hidden in and around their muscles face a higher risk of death or hospitalization from heart disease, according to new research an association that persists regardless of body mass index (BMI).

Research 244
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Flagship-backed Omega signals it’s headed toward bankruptcy

Bio Pharma Dive

Flagship’s Pioneering Medicines initiative could acquire Omega’s assets via a stalking horse bid, according to a regulatory filing.

Medicine 211
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Radiopharmaceutical deals drive sector growth despite supply crisis

Pharmaceutical Technology

Developers celebrate gains for advances with radiopharmaceuticals while regulators and isotope suppliers work to keep up.

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Merck shares tumble as company pauses Gardasil shipments to China

Bio Pharma Dive

Executives pulled back on a 2030 sales target of $11 billion as demand for the HPV shot shrinks amid China market turmoil.

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Italian charity seeks EMA approval for rescued gene therapy

Pharmaceutical Technology

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

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Maze Therapeutics Introduces IPO with Two CKD Candidates in Clinical Trials

XTalks

Maze Therapeutics, a clinical-stage biopharmaceutical company, has raised $140 million in its upsized initial public offering (IPO), pricing shares at $16 each. The company plans to use these funds to advance its groundbreaking research in small molecule precision medicines, targeting renal, cardiovascular and metabolic diseases, including obesity. Current Share Price: The announcement follows a $115 million Series D financing in December 2024, co-led by Frazier Life Sciences and Deep Track Capi

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Reducing Study Start-Up Times: Quality Improvement Practices at a Site Management Organization

ACRP blog

Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines. We pride ourselves on being a watchdog, for example, by making sure that operational elements of the protocol do not over-burden study participants and lead to

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USC receives grant for gene therapy targeting glioblastoma

Pharmaceutical Technology

USC has received a $6m grant from the California Institute for Regenerative Medicine (CIRM) to advance a new gene therapy for glioblastoma.

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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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Experts Share Ways to Streamline Informed Consent Process in Clinical Trial Startup

Advarra

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). The issue? Language relating to the potential cost of participation. One sites language on what they will pay for differs from anothers, and the contradictory wording needs to be reviewed and agreed to by the sponsor before the IRB can proceed.

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Vanda and AnaptysBio link for generalised pustular psoriasis therapy

Pharmaceutical Technology

Vanda and AnaptysBio have announced an exclusive worldwide licence agreement to develop and commercialise imsidolimab to treat GPP.

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

By Faraz Siddiqui & Sara W. Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) was caught in the crosshair once again. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.

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World Cancer Day: WHO warns of rising cancer burden in Southeast Asia

Pharmaceutical Technology

Southeast Asia had the highest number of cervical and childhood cancers among all of the WHO regions in 2022.

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

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Vertical Integration Redux: How Pharmaceutical Wholesalers Are Transforming the Buy-and-Bill Market (Video)

Drug Channels

ICYMI, the largest three pharmaceutical wholesalersCardinal Health, Cencora, and McKessonare using vertical integration to build significant market positions in businesses beyond drug distribution. In the video clip below, I review the vertical integration status of the largest three pharmaceutical wholesalers, illustrated in the chart below. [Click to Enlarge] I also: Explain how wholesalers have strengthened their position in buy-and-bill channels for provider-administered drugs through vertic

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Microplastics: the silent threat

Pharmaceutical Technology

Microplastics, tiny plastic bits less than five millimetres in size, come from breaking down larger plastics and are now everywhere.

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Analyzing biosimilar switching studies: Methodologies and outcomes

Drug Patent Watch

The Rise of Biosimilars: What We Can Learn from Switching Studies As the pharmaceutical industry continues to evolve, one trend is becoming increasingly clear: biosimilars are here to stay. With the patent cliff looming for many biologic medications, biosimilars offer a cost-effective alternative for patients and payers alike. But what happens when patients switch from a brand-name biologic to a biosimilar?

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AstraZeneca lung cancer therapy Imfinzi recommended for EU approval

Pharmaceutical Technology

EMA's CHMP has recommended AstraZeneca's Imfinzi for approval in the EU as a single agent for limited-stage small cell lung cancer (LS-SCLC).

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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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Grifols collaborates with startup FcR Therapeutics to develop autoimmune therapies

Pharma Times

Partnership aims to create recombinant nanobodies to treat immune disorders

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Immunotherapeutic responses and their assessments

Pharmaceutical Technology

Immunotherapeutics have transformed cancer outcomes. It is crucial that response patterns seen with them are assessed accurately.

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GH Research leaps on psychedelic data in depression

pharmaphorum

After setbacks with psychedelics, phase 2b data with GH Research's GH001 for treatment-resistant depression could lift confidence in the category

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Algiax announces results from phase 2a trial for neuropathic pain treatment

Pharma Times

Study shows AP-325 offers lasting pain relief without central side effects

Trials 82
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Solution Spotlight: Axtria Rapid CSR

pharmaphorum

Revolutionise your research process with Axtria Rapid CSR to produce faster and more accurate clinical study reports. Improve efficiency and accuracy in your clinical studies with these advanced solutions.

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Ways to Streamline Informed Consent Process in Clinical Trial Startup

Advarra

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). The issue? Language relating to the potential cost of participation. One sites language on what they will pay for differs from anothers, and the contradictory wording needs to be reviewed and agreed to by the sponsor before the IRB can proceed.

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Algiax non-opioid drug works in chronic neuropathic pain

pharmaphorum

A GABA-targeting drug developed by German Biotech Algiax has shown proof of concept in a chronic neuropathic trial trial.

Drugs 87
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Strengthening Production Efforts Domestically

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Alex Guillen, global pharma and life sciences director at Tive, explains what needs to be done in the United States in order to increase manufacturing output.

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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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Pfizer builds on Braftovi bowel cancer OK with survival data

pharmaphorum

Pfizer's Braftovi, just approved by the FDA as a first-line treatment for colorectal cancer based on response data, also extends patient survival.

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Transforming Specialty Pharmacy Engagement

Pharmaceutical Commerce

A report offers a comprehensive benchmarking and assessment of pharmaceutical manufacturer engagement with specialty pharmacies.

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NHS trial puts AI for breast cancer screening under scrutiny

pharmaphorum

Nearly 700,000 women will be recruited into an NHS trial of AI tools for breast cancer screening, in the hope of relieving pressure on radiologists.

Trials 69
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Pharma Pulse 2/4/25: Pharma Organizations Respond to Proposed Tariffs, Improve Asthma Management with Triple Inhaled Therapy & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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