Sat.May 17, 2025 - Fri.May 23, 2025

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Open New Markets: How Biosimilar Clinical Trials Drive Access, Profitability, and Global Expansion …

ProRelix Research

As the patents for blockbuster biologics expire, a new era of opportunity emerges, ushering in the rise of biosimilars. These biologic alternatives offer the promise of affordable care, broader global […] The post Open New Markets: How Biosimilar Clinical Trials Drive Access, Profitability, and Global Expansion … appeared first on ProRelix Research.

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Regeneron wins bid to buy 23andMe out of bankruptcy

Bio Pharma Dive

The biotech, which has for years invested in genetics research, plans to acquire "substantially all" of testing firm 23andMe's assets for $256 million.

Genetics 289
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Sanofi buys Vigil Neuroscience for $470m in Alzheimer’s push

Pharmaceutical Technology

Sanofi has agreed to acquire Vigil Neuroscience in a $470m deal, nearly a year after investing an initial $40m in the company.

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FDA tightens heart tox warnings on mRNA COVID vaccines

pharmaphorum

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity

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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.

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MHRA approves guselkumab for Crohn’s disease and ulcerative colitis

Pharma Times

Regulator confirms safety and efficacy of new treatment option for patient

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Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

Bio Pharma Dive

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.

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No cardiac safety concerns reported with a pharmaceutically manufactured cannabidiol formulation

Medical Xpress

A pharmaceutically produced cannabidiol formulation had a good overall safety profile, including cardiac safety, according to research presented at Heart Failure 2025.

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World Schizophrenia Awareness Day 2025: Advances in Precision-Driven Clinical Research

XTalks

Observed each year on May 24, World Schizophrenia Awareness Day shines a light on one of the most misunderstood mental health conditions. Schizophrenia is a chronic psychiatric disorder that alters how individuals perceive reality, think and relate to others. Symptoms are typically categorized as positive (hallucinations, delusions), negative (emotional withdrawal, social disconnection) or cognitive (memory or attention deficits).

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FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

Bio Pharma Dive

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

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Genentech to onshore US manufacturing amid rising drug pricing tensions

Pharmaceutical Technology

Genentech has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in North Carolina.

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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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Dopamine and noradrenaline linked to hippocampal activation during light exercise

Medical Xpress

Researchers at the University of Tsukuba investigated whether monoamine neurotransmitters, such as dopamine, are involved in hippocampal activation even during light exercise. Dopamine secreted from the ventral tegmental area of the brainstem and noradrenaline secreted from the locus coeruleus were hypothesized to be involved in a brain neural circuit that regulates hippocampal activation during light exercise.

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Sanofi makes Alzheimer's play with Vigil takeover

pharmaphorum

Sanofi bids to add a drug candidate for Alzheimer's disease to its neurology pipeline via the acquisition of US biotech Vigil Neuroscience

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AI tool could help doctors ID breast cancers vulnerable to Enhertu

Bio Pharma Dive

Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.

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Bayer’s Eylea set for longer treatment intervals to challenge Roche’s Vabysmo

Pharmaceutical Technology

An EMA committee has issued a positive opinion for a label extension that would allow six-month injection intervals for Eylea 8mg.

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Bridging Innovation & Patient Care: The Growing Role of AI

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

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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US approves first blood test for Alzheimer's

Medical Xpress

The United States on Friday approved the first blood test for Alzheimer's, a move that could help patients begin treatment earlier with newly approved drugs that slow the progression of the devastating neurological disease.

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Mixed outcomes for pharma in big week for FDA adcomms

pharmaphorum

There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer

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FDA sets stricter approval standards for COVID vaccines

Bio Pharma Dive

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

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UK biopharma innovator venture financing surges to $1.1bn in Q1 2025

Pharmaceutical Technology

UK biopharmaceutical companies saw a surge in venture financing for innovator drugs in 2024, with double the total deal value from 2022: $827m in 2022 to $1.7bn in 2024.

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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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Better than stitches: Researchers develop biocompatible patch for soft organ injuries

Medical Xpress

University of California, Los Angeles and University of California, San Diego researchers developed an injectable sealant for rapid hemostasis and tissue adhesion in soft, elastic organs.

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AZ partners with Aptar on kidney disease-detecting AI

pharmaphorum

AstraZeneca has turned to another digital health partner to support its aspirations in chronic kidney disease (CKD)

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Roche strikes Orionis deal to develop ‘molecular glues’ for cancer

Bio Pharma Dive

The Swiss pharma has inked several collaborations in this field, suggesting it sees the approach as promising to rid the body of destructive proteins that are hard to target by other means.

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Viz.ai, Sanofi and Regeneron to link for COPD management

Pharmaceutical Technology

Viz.ai is set to enter into a multi-year collaboration with Sanofi and Regeneron for the management of COPD.

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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

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Sonrai and AOA Dx partner to accelerate ovarian cancer test development

Pharma Times

Strategic collaboration aims to improve early diagnosis

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NICE relents and backs drug for IgAN from CSL Vifor

pharmaphorum

Thousands of people living with rare kidney disease IgAN in the UK will soon be able to access a new oral treatment from CSL Vifor

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House passes reconciliation bill with massive Medicaid cuts

Bio Pharma Dive

Speaker Mike Johnson negotiated a number of last minute changes to the megabill to get it across the finish line, including moving up the start date for Medicaid work requirements.

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Wegovy and Zepbound costs capped at $200 in new Evernorth programme

Pharmaceutical Technology

The lower out-of-pocket costs come at a time of governmental scrutiny on prescription drug prices in the US.

Drugs 130
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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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MHRA Board meets in Scotland for first time, reinforcing UK-wide health priorities

Pharma Times

The Board of the Medicines and Healthcare products Regulatory Agency (MHRA) has met in Scotland for the first time, marking a significant step in the agencys approach to delivering health and innovation priorities across the UK.

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Easily distracted? How to improve your attention span

Medical Xpress

Feel like you can't focus? Like you'll never finish a book again? Like the only way to keep your mind and hands busy is to scroll on social media for hours?

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FDA OKs first blood test to aid Alzheimer’s diagnosis

Bio Pharma Dive

The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

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Navigating new EU regulations in the clinical supply chain

Pharmaceutical Technology

We learn how the EUs new Clinical Trial Regulation (CTR) and the CTIS platform are reshaping clinical trial approvals and the supply chain.

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