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
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
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
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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 company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.
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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
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 […]
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.
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.
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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
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.
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).
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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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
LENZ Therapeutics has signed a definitive agreement with Graphite Bio to merge the two businesses in an all-stock deal.
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
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Gastric Cancer.
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.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
NOVEMBER 16, 2023
Astellas Pharma has signed an agreement for the acquisition of Propella Therapeutics in a deal worth $175m.
Pharma Times
NOVEMBER 16, 2023
The bacteriocin development programme will first target pseudomonas aeruginosa - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 16, 2023
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Solid Tumor.
XTalks
NOVEMBER 16, 2023
Air Up, a revolutionary water bottle company, emerged from a unique academic project and rapidly transformed the way we perceive and consume water. Founded by a team of five, including Tim, Lena, Fabian, Jannis and Simon, the Munich-based startup began as a university project in 2016, combining neuroscience and design. By 2019, the Air Up bottle was launched in its home country, paving the way for a new era in hydration.
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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.
Pharmaceutical Technology
NOVEMBER 16, 2023
BT-7480 is under clinical development by Bicycle Therapeutics and currently in Phase II for Solid Tumor.
Intouch Solutions
NOVEMBER 16, 2023
Last week, Frontiers Health, the premier global digital health innovation event, was held in Rome, Italy. The annual event assembled nearly 1,000 attendees from over 40+ countries across the healthcare ecosystem to learn, network and explore industry challenges, strategic trends and solutions in life sciences and healthcare. While Frontiers Health has always been a flagship event for EVERSANA INTOUCH and our clients to attend each year, this year’s event was significant as we were proud to co-ho
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.
Intouch Solutions
NOVEMBER 16, 2023
Following a wildly successful Frontiers Health event , agency leaders Faruk Capan, CEO, EVERSANA INTOUCH and Chief Innovation Officer, EVERSANA, and Angela Tenuta, President, Full-Service Agencies, EVERSANA INTOUCH, along with EVERSANA team members had the opportunity to celebrate the newest additions to the EVERSANA family, the Healthware Group team, in person at an employee welcome reception.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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