BioPharma Reporter
NOVEMBER 16, 2023
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.
Bio Pharma Dive
NOVEMBER 16, 2023
Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.
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Pharmaceutical Technology
NOVEMBER 16, 2023
Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.
Bio Pharma Dive
NOVEMBER 16, 2023
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.
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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.
Pharmaceutical Technology
NOVEMBER 16, 2023
Ardelyx scores another FDA win after Xphyozah was approved by the FDA in October as an add-on therapy for chronic kidney disease patients.
Bio Pharma Dive
NOVEMBER 16, 2023
The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas.
Bio Pharma Dive
NOVEMBER 16, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 16, 2023
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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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
Bio Pharma Dive
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
The UK MHRA extended the licence of Vertex Pharmaceuticals’ cystic fibrosis drugs, Kaftrio and Kalydeco for children aged two to five years.
Bio Pharma Dive
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
Certa plans to discuss trial plans with the FDA in early 2024, with the trial set to begin later in the year.
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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.
Fierce Pharma
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
Augtyro (repotrectinib) is the only FDA-approved tumour kinase inhibitor (TKI) for ROS1-positive non-small cell lung cancer (NSCLC).
Fierce Pharma
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
LENZ Therapeutics has signed a definitive agreement with Graphite Bio to merge the two businesses in an all-stock deal.
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
BioSpace
NOVEMBER 16, 2023
In briefing documents for Friday’s advisory committee meeting, the regulator has expressed concerns about the effectiveness of the company’s P2X3 receptor antagonist gefapixant.
Pharmaceutical Technology
NOVEMBER 16, 2023
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Gastric Cancer.
BioSpace
NOVEMBER 16, 2023
When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.
Pharmaceutical Technology
NOVEMBER 16, 2023
Astellas Pharma has signed an agreement for the acquisition of Propella Therapeutics in a deal worth $175m.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Fierce Pharma
NOVEMBER 16, 2023
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
Pharmaceutical Technology
NOVEMBER 16, 2023
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Solid Tumor.
BioSpace
NOVEMBER 16, 2023
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.
Pharmaceutical Technology
NOVEMBER 16, 2023
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Solid Tumor.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
BioSpace
NOVEMBER 16, 2023
Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.
pharmaphorum
NOVEMBER 16, 2023
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.
BioSpace
NOVEMBER 16, 2023
The company's Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.
Drug Discovery World
NOVEMBER 16, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
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