Thu.Jan 30, 2025

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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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MHRA launches refreshed ILAP to speed up NHS drug access

Pharmaceutical Technology

The pathway allows medicine developers to work with the regulators, the NHS and health technology assessment bodies.

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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.

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Takeda announces appointment of Julie Kim as CEO

Pharmaceutical Technology

Takeda has announced the appointment of Julie Kim as the successor to Christophe Weber, effective from June 2026.

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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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RFK Jr. fumbles Medicare basics during second confirmation hearing

Bio Pharma Dive

Robert F. Kennedy Jr., nominated to be health secretary, seemed unfamiliar with the particulars of the massive insurance program he'd oversee in exchanges with senators Thursday.

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Leveragen and Moonlight Bio unite for T-cell therapy development

Pharmaceutical Technology

Leveragen has announced a strategic partnership with Moonlight Bio, targeting the development of T-cell therapies for challenging cancers.

More Trending

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Acellera and Psivant partner for AI-driven drug discovery

Pharmaceutical Technology

Acellera and Psivant have announced a strategic research partnership aimed at developing computational drug discovery approaches.

Drugs 147
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Christophe Weber, veteran Takeda CEO, to retire next year

Bio Pharma Dive

Julie Kim, currently Takeda’s U.S. head, will replace Weber in June 2026 and become one of the few female CEOs of a top drugmaker.

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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

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Cargo to drop lead CAR-T therapy, lay off staff after study setback

Bio Pharma Dive

Safety concerns and disappointing efficacy results have led Cargo to stop testing the treatment, cut 50% of its workforce and evaluate strategic alternatives.

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

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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

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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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Marketing Your Patented Drug Effectively: Strategies for Maximizing Patent Protection and Exclusivity

Drug Patent Watch

Maximizing Patent Protection: Strategies for Pharmaceutical Marketers As a pharmaceutical marketer, you know how crucial it is to protect your patented drug's market share. But with the ever-changing landscape of the industry, it can be challenging to stay ahead of the competition. In this post, we'll explore effective strategies for maximizing patent protection and exclusivity, ensuring your product remains a leader in the market.

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Could an ECG spot people at risk of cognitive decline?

pharmaphorum

UK Biobank study suggests someone's risk of premature ageing or cognitive decline could be predicted using a simple ECG reading supported by an AI

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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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Velocity Partners with Verified Clinical Trials to Combat Double Enrollment Problem in Clinical Trials

Velocity Clinical Research

Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites. The collaboration addresses a critical industry challenge: the double enrollment of participants in multiple studies simultaneously across all clinical sites.

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Expert Insights: Development and Manufacture of Highly Potent Oral Liquids

XTalks

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients. In many cases, this guidance translates to a seemingly simple solution: for children, liquid formulations are often the preferred approach.

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The Power of Data and Machine Learning to Optimize HCP Prescription Volume

Intouch Solutions

In a recently published article from Med Ad News , co-authors Iyiola Obayomi, SVP, Managing Director, Data & Analytics, at EVERSANA INTOUCH, and Pierantonio Russo, MD, FCPP, FAAP, STS, Chief Medical Officer at EVERSANA, discuss the power of data and analytics and machine learning (ML) to optimize HCP targeting and prescription volume. In an era where AI and ML in healthcare are driving significant prescription gains by engaging healthcare professionals (HCPs) more effectively, success now de

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Dust mite allergy sufferers set for a new NHS treatment

pharmaphorum

ALK-Abello's Acarizax for dust mite allergy should soon be available through the NHS in England, Wales, and Northern Ireland, but not in Scotland.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma Pulse 1/30/25: Treating Disruptive Symptom’s in Crohn’s Patients, Majority of Americans Support Medicare and Medicaid & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Takeda CEO succession confirmed as Weber plans retirement

pharmaphorum

Takeda's long-serving chief executive Christophe Weber has said he will retire next year, after 12 years at the Japanese drugmaker.

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Lantheus to acquire Evergreen in $1bn deal to expand radiopharmaceutical pipeline

Outsourcing Pharma

Lantheus is acquiring radiopharmaceutical CDMO Evergreen Theragnostics in a deal worth up to $1 billion, expanding its manufacturing capabilities and drug pipeline. The acquisition includes Octevy, a PET imaging agent for neuroendocrine tumors, pending FDA approval.

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Life Sciences Industry Report - Part 6

pharmaphorum

Discover valuable insights into the rare disease landscape in Part 6 of our Life Sciences Industry Report. This white paper provides in-depth analysis and key findings for industry professionals.

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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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Determining the Correlation Between Obesity Management Drug Dispensed Prescriptions and Online Search Behavior

Pharmaceutical Commerce

Can monitoring these dispensed Rxs via online search behavior help predict future GLP-1 use in the United States?

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HCP marketing’s Pharma 4.0 moment: Leveraging AI for real-time campaign optimisation

pharmaphorum

HCP marketings Pharma 4.0 moment: Leveraging AI for real-time campaign optimisation Mike.

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Setback for Inhibikase Parkinson’s therapy

BioPharma Reporter

Inhibikase Therapeutics announced disappointing results from a Phase 2 trial for its Parkinsons disease drug, risvodetinib, and will now pause its development.

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Closing the gap: Combatting Misinformation in men’s healthcare

pharmaphorum

Explore effective health strategies and initiatives aimed at combatting misinformation in men's healthcare, particularly in the realm of mental health.

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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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Fair Market Value vs. Current Market Leverage

Pharmaceutical Commerce

How pharmaceutical manufacturers should consider their Fair Market Value cost assessment compared to their negotiation leverage when contracting for distribution services

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3rd Precision Medicine in Inflammatory Bowel Disease Summit | May 13-15, 2025

pharmaphorum

Join us at the 3rd Precision Medicine in Inflammatory Bowel Disease Summit on May 13-15, 2025, organised by Hanson Wade. This event will bring together experts to discuss the latest advancements in precision medicine for IBD.

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What Round II of Medicare Part D Drug Prices Signify for the Pharma Industry

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, value & access advisor for Schoonveld Advisory and author of The Price of Global Health, comments on the future implications of the latest CMS drug price negotiations.

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Simulated clinical trial populations and AI scalability

pharmaphorum

In a new pharmaphorum podcast with ZS Associates Sharon Karlsberg, principal and leader of oncology solutions, and Brandi Davis-Dusenbery, principal and partner, web editor Nicole Raleigh explores the potential for scaling advanced technologies in the biopharmaceutical 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.