Thu.Jan 16, 2025

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‘The bar has risen’: China’s biotech gains push US companies to adapt

Bio Pharma Dive

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference.

Drugs 361
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BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

XTalks

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. Called exPDite-2, the registrational trial meaning a trial designed to gather the necessary data for potential regulatory approval is slated to begin in the first half of 2025.

Trials 104
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Roche’s new deals head tries to navigate a more ‘complicated’ and ‘expensive’ biotech world

Bio Pharma Dive

Roche's core research spans five large areas. Boris Zaïtra, who now leads corporate business development, is confident his team of dealmakers can juggle them.

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Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Rethinking Clinical Trials

Speakers Dana Dailey PT, PhD Assistant Research Scientist Physical Therapy and Rehabilitation Science University of Iowa Associate Professor, Physical Therapy Department St. Ambrose University Heather Schacht Reisinger, PhD Director, Implementation Science Center Associate Director for Engagement, Integration, and Implementation Institute for Clinical and Translational Science Professor, Division of General Internal Medicine at the University of Iowa Slides Keywords Commun

Trials 100
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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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JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson

Bio Pharma Dive

AbbVie's CEO hinted his company may be less willing to invest in psychiatry after a costly setback, while Lilly explained what it got wrong forecasting GLP-1 drug demand.

Drugs 316
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Qiagen Receives FDA Clearance for First Mini Gastrointestinal Panel

XTalks

Qiagen received FDA clearance for its new QIAstat-Dx mini gastrointestinal panel last week. According to Qiagen, the test is the first in a series of QIAstat-Dx gastrointestinal (GI) panel tests for clinical use. The new QIAstat-Dx Gastrointestinal Panel 2 mini B&V (bacterial and viral) is designed for the rapid outpatient diagnosis of gastrointestinal conditions.

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Navigating Asthma During the Flu Season: Tips for Staying Healthy and Safe

Antidote

When preparing for flu season, those with asthma may have concerns about how the virus can affect their respiratory health and breathing. While asthma is a manageable condition, it does require extra care when dealing with seasonal illnesses like the flu. In this blog, we'll explore how asthma and the flu interact, provide tips for managing both, and offer resources to help you stay informed and prepared.

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JPM 2025: WuXi AppTec rebuffs concern about lower GLP-1 demand after Lilly’s low revenue forecast

Pharmaceutical Technology

Six out of 31 total new small molecules approved by the FDA in 2024 were produced by Wuxi, said the company's co-CEO.

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Lilly’s Omvoh approved by FDA for Crohn’s

Bio Pharma Dive

The clearance broadens use of Omvoh, which is part of a slate of new medicines Lilly is counting on to build on its success in diabetes and obesity.

Medicine 179
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“Nothing to do with geopolitics”: WuXi Biologics CEO bullish in face of Biosecure

Pharmaceutical Technology

At the JP Morgan Conference 2025, CEO Chen said the potential of the Biosecure Act passing has had only a minimal chilling effect on clients.

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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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Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

XTalks

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). The trial met its primary endpoint of proptosis (protrusion of the eyeball from the orbit) reduction with statistical significance at the 150 mg BID (twice a day) dose.

Trials 59
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JP Morgan 2025: Radiopharmaceuticals M&A fuels Telix’s busy year

Pharmaceutical Technology

The radiopharmaceutical developer expanded its reach, acquiring R&D, isotope production, manufacturing, and distribution.

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The Future of Patent Intelligence Tools: How AI is Revolutionizing the Landscape

Drug Patent Watch

The Rise of AI in Patent Intelligence AI has been making strides in various industries, and the patent sector is no exception. The integration of AI into patent intelligence has been a game-changer, offering unprecedented levels of efficiency, accuracy, and depth in analysis. Generative AI and Large Language Models (LLMs) Generative AI, particularly Large Language Models (LLMs), has become a cornerstone in the evolution of patent intelligence.

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Santhera launches DMD therapy in the UK following NICE nod

Pharmaceutical Technology

Santhera Pharmaceuticals has started launch preparations for its DMD drug Agamree (vamorolone) in the UK, after a recommendation from NICE.

Drugs 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Biofidelity and CellCarta partner to deploy Aspyre Lung in global clinical trials

Pharma Times

New partnership to advance precision medicine in lung cancer diagnosis

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European supergroup launches to tackle diversity in clinical trials

Pharmaceutical Technology

The new pan-European group of 73 regulators, companies and trial sites is backed by 66.8m in funding with a six-year goal.

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Actinogen boosts trial with Cambridge Cognition’s digital suite

Pharma Times

Partnership aims to advance Alzheimer's research with innovative tools

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Lyndra and Thermo Fisher partner for oral therapies

Pharmaceutical Technology

Lyndra Therapeutics and Thermo Fisher Scientific have entered a strategic partnership for Lyndra's long-acting oral therapies.

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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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Bioptimus raises $41m for its GenAI model for biology

pharmaphorum

AI start-up Bioptimus takes its funding above $76m as it prepares for the launch of a universal foundation model for pathology later this year.

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Be Bio secures $92m for haemophilia B and hypophosphatasia treatments

Pharmaceutical Technology

Be Biopharma has secured $92m in a Series C financing round to advance its clinical programmes for haemophilia B and hypophosphatasia.

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Lilly nets a second FDA okay for Omvoh, in Crohn's disease

pharmaphorum

Eli Lilly picks up a second FDA approval for IL-23 inhibitor Omvoh in Crohn's disease, but will it kickstart sales growth

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Designing clinical trials for a complex disease: pediatric obesity

Pharmaceutical Technology

Treating the growing problem of childhood obesity calls for exploring new approaches and treatments through well-designed clinical trials.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA bans red dye used in medicines over cancer risk

pharmaphorum

The FDA has banned the use of a red dye used in oral medicines, foods, and dietary supplements, more than 30 years after it was linked to cancer.

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JP Morgan 2025: GoodRx takes aim at US drug pricing challenges

Pharmaceutical Technology

GoodRx CEO Wendy Barnes outlined the company's priorities at the 2025 JP Morgan Healthcare Conference in San Francisco.

Drugs 147
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Santhera preps UK Duchenne drug launch after NICE says yes

pharmaphorum

Santhera will launch its new drug for Duchenne muscular dystrophy in the UK within the next few weeks after getting the green light for NHS coverage

Drugs 98
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Meridian Medical wins $129m US gov contract for nerve agent antidote supply

Pharmaceutical Technology

Meridian Medical Technologies has won a new contract worth up to $129m from the US for the supply of its DuoDote nerve agent antidote autoinjectors to the SNS.

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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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Driving innovation in clinical trials: Patient perspectives and multidimensional assessments

Outsourcing Pharma

Driving Innovation in Clinical Trials: Patient Perspectives and Multidimensional Assessments

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Life Sciences Industry Report – Part 3

pharmaphorum

Across every corner of the industry, from research and development to patient engagement, AI, and most recently generative AI (GenAI), is driving profound change.

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Overcoming clinical trial obstacles with AI: WCG’s outlook for SCOPE 2025

Outsourcing Pharma

Explore WCG's cutting-edge AI and tech solutions, including ClinSphere Total Enrollment, transforming clinical trials at SCOPE 2025.

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J&J files intravesical bladder cancer drug TAR-200 in US

pharmaphorum

Johnson & Johnson has started a marketing application in the US for TAR-200 as a treatment for non-muscle-invasive bladder cancer (NMIBC).

Drugs 75
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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