Thu.Jan 23, 2025

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BridgeBio’s Neil Kumar on an underdog drug launch and wooing deal-hungry investors

Bio Pharma Dive

In an interview, the CEO discussed trying to gain support from investors hyper-focused on M&A, and competing with Pfizer and Alnylam in a closely watched commercial battle.

Drugs 354
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FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases

Pharmaceutical Technology

The FDA reported that six patients died after being injected with Tevas Copaxone or Sandozs Glatopa.

Drugs 264
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Strategies for effective biosimilar clinical trial design and execution

Drug Patent Watch

Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product.

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Ascentage prices first biotech IPO of 2025, raising $126M

Bio Pharma Dive

The China-based cancer drug developer’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.

Medicine 179
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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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The Future of Generic Drug Development for Emerging Markets: Opportunities and Challenges

Drug Patent Watch

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. With the rise of affordable healthcare initiatives and growing demand for quality medicines, emerging markets present a significant opportunity for generic drug manufacturers to expand their reach and improve access to life-saving treatments.

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Viralgen and Axovia to develop gene therapy for retinal dystrophy

Pharmaceutical Technology

Viralgen and Axovia are set to form a partnership to progress the development and manufacturing of gene therapy for retinal dystrophy

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Bladder cancer: Shaping the future of global clinical trials

Pharmaceutical Technology

A new report dives into the evolving clinical trial landscape and transformative therapies changing lives for bladder cancer patients.

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What Sponsors Should Look for in Patient Recruitment Partners

Antidote

Effective patient recruitment is a critical component of clinical trials, and for pharmaceutical companies, Contract Research Organizations (CROs), and other sponsors, selecting the right partner is key to ensuring that trials are successful, timely, and cost-effective. As clinical trials grow in complexity and size, the need for expert patient recruitment partners who can navigate the challenges of finding and enrolling suitable participants has never been greater.

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Pharmaceutical Technology Excellence Awards 2024 – Winners Announced!

Pharmaceutical Technology

The Pharmaceutical Technology Excellence Awards winners have been announced!

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Tris Pharma announces positive results from ALLEVIATE-1 trial of cebranopadol

Pharma Times

Phase 3 trial shows promising pain relief for acute pain patients

Trials 137
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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 grants ODD status to Zai Lab’s lung cancer treatment

Pharmaceutical Technology

The FDA has granted orphan drug designation (ODD) to Zai Labs ZL-1310, aimed at treating small cell lung cancer (SCLC).

Drugs 147
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Zydus announces USFDA Orphan Drug Designation for Usnoflast in ALS treatment

Pharma Times

Orphan drug designation offers development incentives and potential market exclusivity

Drugs 132
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Cellipont and Secretome link to manufacture cGMP cellular therapy

Pharmaceutical Technology

Cellipont and Secretome Therapeutics are set to enter a collaboration for the manufacturing of the latters cellular therapy, STM-01.

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Reflecting on a decade at CES: Has digital health really transformed?

pharmaphorum

This article reflects on the past decade at CES to assess how digital health innovations, including AI, have transformed the healthcare industry.

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

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Disc raises $225.5m as it eyes approval of rare skin disorder drug  

Pharmaceutical Technology

Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA earlier this week.

Medicine 147
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AMR biotech BioVersys plans to float on Swiss stock exchange

pharmaphorum

BioVersys has filed to list on the Swiss Stock Exchange, hoping to raise CHF80m for its novel antibacterial candidates.

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Emergent seeking to reverse fortunes and become a major overdose treatment player

Pharmaceutical Technology

Emergent Biosolutions (Gaithersburg, US) has purchased US and Canadian rights to Kloxxado, adding to its opioid overdose treatment portfolio, which includes Narcan.

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Tris cues up filing for non-opioid pain drug on phase 3 win

pharmaphorum

Tris Pharma has set its sights on an FDA filing for non-opioid pain drug cebranopadol this year after hitting the mark in an abdominoplasty trial.

Drugs 100
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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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Pharmaceutical Technology Excellence Awards 2024: Catalent

Pharmaceutical Technology

Global CDMO Catalent won in two categories in the 2024 Pharmaceutical Technology Excellence Awards.

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Study finds big life expectancy deficit in adults with ADHD

pharmaphorum

UK study finds adults with ADHD have a big shortfall in life expectancy, raising questions about diagnosis rates and treatment access.

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Magazine: The biggest challenges clinical trials will face in 2025

Pharmaceutical Technology

The year ahead in clinical trials looks set to be one that is challenged and influenced by regulatory developments, new guidance, and broader political shifts.

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The largest pharma acquisitions of 2024

Outsourcing Pharma

From Novo Holding's purchase of Catalent to BMS's Karuna acquisition, here are 10 of the most significant M&A moments of 2024.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Comprehensive EPCM(v) Services by ZETA: Ensuring Excellence in Pharmaceutical and Biotech Projects

Pharmaceutical Technology

Investment projects in the pharmaceutical and biotechnology industries require a high level of expertise and coordination due to their complexity…

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Velocity is a Founding Member of the Association of MultiSite Research Corporations

Velocity Clinical Research

Were proud to announce that Velocity is a founding member of the newly launched Association of MultiSite Research Corporations (AMRC)! This innovative trade association unites 14 leading organizations to address the systemic challenges in clinical trials and drive meaningful change across the industry. With over 80 fully integrated research sites across the U.S. and Europe and a network of more than 1.5M participants, Velocity is committed to patient-centric care, superior recruitment, and relia

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What is Electronic Data Capture? An Overview EDC System in Clinical Trials

Clinion

Electronic Data Capture (EDC) systems are specialized software platforms designed to collect, manage, and store data in clinical trials. They replace traditional paper-based methods with secure, efficient, and highly accurate digital solutions. By automating data collection and streamlining management processes, EDC systems enhance data quality, minimize errors, and ensure compliance with regulatory standards.

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Rare disease and the women's health gap

pharmaphorum

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Jennifer Schranz, head of rare diseases at Ipsen, for a conversation focused on rare liver disease primary biliary cholangitis (PBC), which affects nine women for every one man, and the womens health gap more generally.

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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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Fostering Relationships and Leadership Within the Trade Sector

Pharmaceutical Commerce

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Amanda Salindong, associate director of channel & distribution at Alnylam Pharmaceuticals, explains the premise of the Trade & Channel sessions that she participated in, along with some of the audience feedback that she received.

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Life Sciences Industry Report - Part 5

pharmaphorum

Stay updated on the latest trends and advancements in the life sciences industry, specifically focusing on oncology and cancer therapies with Part 5 of our comprehensive industry report. Learn more about the cutting-edge care options available.

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Pharma Pulse 1/23/25: Key Markets Investors Can’t Ignore, Moderna Gets $590 Million for Bird Flu Vaccine Development & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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2025 predictions and AI trends for pharma executives

pharmaphorum

Stay ahead of the game with our 2025 predictions and AI trends for pharma executives. Explore how AI is transforming drug development, healthcare, and regulatory processes.

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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