Thu.Nov 16, 2023

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Not-for-profit alliance advocates for life sciences collaboration

BioPharma Reporter

The Pistoia Alliance is a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D. It has just announced its four new strategic priorities made up of global pharma and tech representatives to deliver new project ideas to drive industry change.

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World’s first CRISPR medicine approved in UK for sickle cell, beta thalassemia

Bio Pharma Dive

Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.

Medicine 317
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World’s first CRISPR-based gene therapy approved for sickle cell anaemia

Pharmaceutical Technology

Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.

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West Coast investor Red Tree on its San Diego expansion and staying bullish in biotech

Bio Pharma Dive

Red Tree Venture Capital plans to tap into San Diego’s biotech pipeline as it works to build a West Coast competitor to Boston-area investors.

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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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Xphozah wins orphan drug designation for paediatric hyperphosphatemia

Pharmaceutical Technology

Ardelyx scores another FDA win after Xphyozah was approved by the FDA in October as an add-on therapy for chronic kidney disease patients.

Drugs 246
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FDA approves new Bristol Myers drug for lung cancer

Bio Pharma Dive

Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.

More Trending

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Homology enters reverse merger with Q32 Bio

Bio Pharma Dive

The deal, which will result in a combined company operating under Q32's name, comes months after Homology laid off much of its staff and halted research.

Research 274
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FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Pharmaceutical Technology

The mRNA therapy may help to accelerate the regeneration of the urinary sphincter muscle, treating women with stress urinary incontinence.

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Paper details Astellas gene therapy study that led to patient deaths

Bio Pharma Dive

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

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An ‘Extra Fold’ in The Human Brain May Delay Early Dementia by Years

AuroBlog - Aurous Healthcare Clinical Trials blog

Few people had probably heard of frontotemporal dementia until earlier this year, when the family of actor Bruce Willis announced the 68-year-old had been diagnosed with the condition. Frontotemporal dementia is a rare disease – thought to account for only one in every 20 cases of dementia.

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

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Top FDA official Woodcock to retire early next year

Bio Pharma Dive

The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

Drugs 173
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State govts should carry forward all projects introduced by Centre to promote Ayurveda: Dr Ramanathan

AuroBlog - Aurous Healthcare Clinical Trials blog

On the occasion of National Ayurveda Day, the Ayurveda Medicine Manufacturers Association of India (AMMOI) has called upon the state governments that the constructive steps being taken by the Union Ayush Ministry to make Ayurveda system of treatment as an alternative treatment method for the world population should be taken forward by all state governments […]

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Certa plans pivotal scleroderma trial after Phase II data readout

Pharmaceutical Technology

Certa plans to discuss trial plans with the FDA in early 2024, with the trial set to begin later in the year.

Trials 147
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Glox Therapeutics secures £4.3m seed funding to combat AMR

Pharma Times

The bacteriocin development programme will first target pseudomonas aeruginosa - News - PharmaTimes

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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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Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries

Fierce Pharma

Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries fkansteiner Thu, 11/16/2023 - 11:08

Vaccine 130
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LifeArc and UKDRI invest £14.5m into neurodegeneration research

Pharma Times

The funding will be used to develop new diagnostic tests, treatments and devices - News - PharmaTimes

Research 137
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BT-7480 by Bicycle Therapeutics for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Gastric Cancer.

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Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Fierce Pharma

Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. | Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BT-7480 by Bicycle Therapeutics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Solid Tumor.

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Pharma is racing to oncology's first line, causing a rethink of early-stage disease treatment

Fierce Pharma

Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas' MD Anderson Cancer Center. | Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner.

Drugs 126
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BMS strengthens NSCLC market share with ROS1 drug Augtyro

Pharmaceutical Technology

Augtyro (repotrectinib) is the only FDA-approved tumour kinase inhibitor (TKI) for ROS1-positive non-small cell lung cancer (NSCLC).

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Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

Fierce Pharma

Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

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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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UK MHRA extends licence for Vertex’s children’s cystic fibrosis drugs

Pharmaceutical Technology

The UK MHRA extended the licence of Vertex Pharmaceuticals’ cystic fibrosis drugs, Kaftrio and Kalydeco for children aged two to five years.

Drugs 130
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Life sciences inspections and investigations

pharmaphorum

Life sciences inspections and investigations Mike.

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LENZ Therapeutics and Graphite Bio agree to merge

Pharmaceutical Technology

LENZ Therapeutics has signed a definitive agreement with Graphite Bio to merge the two businesses in an all-stock deal.

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Retaining the human element of AI within pharma and healthcare

pharmaphorum

In this episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions, about the ins and outs of successful AI implementation within pharma and healthcare.

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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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Astellas agrees to take over Propella Therapeutics for $175m

Pharmaceutical Technology

Astellas Pharma has signed an agreement for the acquisition of Propella Therapeutics in a deal worth $175m.

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UK first to approve Vertex, CRISPR drug for blood disorders

pharmaphorum

UK first to approve Vertex, CRISPR drug for blood disorders Phil.

Drugs 111
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Welcome to the Brave New World of CRISPR Gene Editing

BioSpace

The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.

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BMS gets US approval for ROS1 lung cancer drug Augtyro

pharmaphorum

BMS gets US approval for ROS1 lung cancer drug Augtyro Phil.

Drugs 110
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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.