Sat.Jan 25, 2025 - Fri.Jan 31, 2025

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Cannabis Compound Discovered Inside Totally Different Plant

AuroBlog - Aurous Healthcare Clinical Trials blog

A type of Trema micrantha. (Daniel Pineda Vera/iNaturalist/CC BY 4.0) Scientists have discovered cannabidiol, a compound in cannabis known as CBD, in a common Brazilian plant, opening potential new avenues to produce the increasingly popular substance.

Scientist 147
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Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research

Bio Pharma Dive

Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.

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FDA approves Vertex’s acute pain treatment Journavx

Pharmaceutical Technology

The FDA has approved Vertex Pharmaceuticals oral Journavx (suzetrigine) to treat adults with moderate-to-severe acute pain.

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January 29, 2025: Early Lessons From ARBOR-Telehealth, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Richard Skolasky and Kevin McLaughlin of Johns Hopkins University will present “Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned.” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clini

Trials 173
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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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FDA approves new Alzheimer’s treatment regimen

Pharma Times

Patients and care partners may find once every four weeks maintenance dosing easier

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Atalanta banks $97M to send RNAi drugs into the brain

Bio Pharma Dive

The startup says its specially constructed RNAi therapies can get deep into brain tissue, yielding new ways to treat neurological conditions like Huntington’s.

Drugs 334

More Trending

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog

By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated

Trials 105
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Vedanta Biosciences reveals Phase 2 VE303 results

Pharma Times

Study highlights VE303's potential in reducing recurrent CDI

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A new, non-opioid pain drug is here. Getting it to patients could be agony.

Bio Pharma Dive

After decades of research, Vertex Pharmaceuticals now has an approved pain medication. Can one of the world’s most powerful biotechs contend with a healthcare system that’s long favored opioids?

Drugs 322
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Pfizer settles Biohaven kickback claims case for $59.7m

Pharmaceutical Technology

Biohaven, acquired by Pfizer in 2022, allegedly took doctors to high-end restaurants and paid speaker honoraria for preferential prescriptions.

Doctors 261
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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GSK backs £50m Oxford University cancer vaccine programme

pharmaphorum

A GSK alliance with Oxford University aims to identify precancerous changes in cells that could form the basis of preventive vaccines.

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Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Rethinking Clinical Trials

Speaker Jeffrey H. Samet, MD, MA, MPH John Noble Professor in General Internal Medicine & Professor of Public Health Boston University Chobanian and Avedisian School of Medicine and School of Public Health Boston Medical Center Slides Keywords Opioid Epidemic; Evidence-Based Practices; NIH HEAL Initiative; MOUD; OEND; Harm Reduction Key Points Over roughly 20 years, opioid overdose (OD) mortality in the U.S. increased tenfold: from a little over 8,000 in 1999 to over

Trials 100
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Enhertu, with new FDA OK, set to supplant chemo in HER2-low breast cancer

Bio Pharma Dive

The clearance is a step forward in AstraZeneca and Daiichi Sankyo’s plan to position antibody-drug conjugates like Enhertu ahead of chemotherapy in a variety of tumors.

Antibody 317
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Roche targets continued growth after strong 2024 sales

Pharmaceutical Technology

Roche achieved a sales growth of 7% (3% in CHF) in 2024, citing strong demand for pharmaceutical products.

Sales 233
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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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Alligator Bioscience reports survival benefit of mitazalimab with mFOLFIRINOX

Pharma Times

Comparison shows improved survival rates for pancreatic cancer treatment

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Gut microbes may mediate the link between drinking sugary beverages and diabetes risk

Medical Xpress

It is well known that consuming sugary drinks increases the risk of diabetes, but the mechanism behind this relationship is unclear. Now, in a paper appearing in Cell Metabolism, researchers show that metabolites produced by gut microbes might play a role.

Research 104
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FDA clears use of Ozempic to protect kidney health

Bio Pharma Dive

The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, which hasn’t yet proven it can improve outcomes in kidney disease.

Drugs 257
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Will European PFAS ban disrupt pharma supply chains?

Pharmaceutical Technology

A proposed ban on PFAS chemicals is being challenged over concerns about potential supply chain disruption in the pharmaceutical industry.

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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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Pfizer offers $60m to settle prescriber kickback claims

pharmaphorum

Pfizer has paid $60m to settle US government allegations that its Biohaven unit made improper payments to prescribers of its migraine drug Nurtec ODT.

Drugs 105
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Experimental drug speeds up myelin repair, restoring vision in mice

Medical Xpress

Researchers at the University of Colorado Anschutz Medical Campus have found a promising drug candidate that could help restore vision in individuals with multiple sclerosis (MS) and other neurological conditions that damage neurons.

Drugs 106
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Are we overlooking something critical in cell and gene therapy research?

Bio Pharma Dive

Taking control of O2 — ushering in the future of cell therapy research.

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The AI advantage in discovering new medicines 

Pharmaceutical Technology

With continued investment and growing buzz from the industry, the AI hype is expected to extend through 2025 and beyond.

Medicine 179
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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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Six life sciences real estate trends to watch in 2025

pharmaphorum

Stay ahead of the game by keeping an eye on these six life sciences real estate trends to watch in 2025. From AI integration to collaborative incubator spaces, the industry is evolving rapidly.

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Rising early adult mortality in the US: Death rates remain higher than expected post-pandemic

Medical Xpress

New research from the University of Minnesota shows that death rates for early adults, or adults aged 2544, rose sharply during the COVID-19 pandemic and remain higher than expected post-pandemic.

Research 102
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23andMe considers a sale as cash runs low

Bio Pharma Dive

The testing company ended last year with $79 million and told investors it will need to raise money to fund its operations and financial commitments.

Sales 226
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Tevogen Bio and Microsoft expand AI collaboration to PredicTcell tech

Pharmaceutical Technology

Tevogen Bio has expanded its partnership with Microsoft, aiming to further their collaboration centred on AI and advance PredicTcell.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Key trends shaping pharmaceutical operations in 2025

pharmaphorum

Stay ahead of the curve by exploring the key trends shaping pharmaceutical operations in 2025, including cybersecurity, efficiency, workforce management, and technology advancements. Learn more about these important industry developments.

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Does drinking alcohol really take away the blues? It's not what you think

Medical Xpress

A new study from the University of Chicago Medicine reveals that people with alcohol use disorder (AUD) and depression experience high levels of stimulation and pleasure when intoxicated, similar to drinkers who do not have depression.

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Metsera, Maze secure combined $415 million in IPOs

Bio Pharma Dive

The offerings reflect an increase in IPO activity that could continue, as four other biotechs recently outlined plans to go public.

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AB2 Bio and Nippon Shinyaku enter Tadekinig alfa licensing deal

Pharmaceutical Technology

AB2 Bio has made an option and licensing agreement with Nippon Shinyaku, granting the latter the option to commercialise Tadekinig alfa.

Licensing 162
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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.