Unleashing Innovation: The Case for Permissionless R&D in Pharma
Drug Patent Watch
MARCH 22, 2024
A recent article in Communications of the ACM explores opportunities for “Permissionless innovation” in pharmaceuticals.
Fri.Mar 22, 2024
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FDA clears first-of-its-kind Duchenne drug for broad use
Bio Pharma Dive
MARCH 22, 2024
The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.
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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes
Pharmaceutical Technology
MARCH 22, 2024
The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.
Medicare to cover Novo’s obesity drug for some patients
Bio Pharma Dive
MARCH 22, 2024
Two weeks after the FDA updated Wegovy’s label, Medicare changed its stance to allow people with a history of heart disease to receive treatment, a shift that could further boost access to the fast-selling medicine.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
FDA grants orphan drug status to HI-Bio’s felzartamab for AMR
Pharmaceutical Technology
MARCH 22, 2024
The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.
Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli
Fierce Pharma
MARCH 22, 2024
Sales are booming for Novo Nordisk’s GLP-1 treatments for diabetes and obesity. But that doesn’t mean the Danish company has moved on from its previous generation of blood sugar modulators. | With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market.
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Italfarmaco nabs FDA approval for new Duchenne med, teeing up sparring match with Sarepta
Fierce Pharma
MARCH 22, 2024
At a watershed moment for Duchenne muscular dystrophy (DMD) treatment, privately held Italian drugmaker Italfarmaco has added a new therapeutic option to the armamentarium against the debilitating | At a watershed moment for Duchenne muscular dystrophy treatment, privately held Italian drugmaker Italfarmaco has added a new therapeutic option to the armamentarium against the debilitating muscle-wasting disorder.
Cellectis files patent for engineered T-cells for immunotherapy with inhibited B2M expression
Pharmaceutical Technology
MARCH 22, 2024
Discover Cellectis SA's groundbreaking patent for engineered T-cells designed for immunotherapy, targeting cancer, infections, and autoimmune diseases. Learn about the innovative method and composition outlined in the patent for effective and affordable treatment.
The 3 biggest mistakes we keep making in clinical operations
pharmaphorum
MARCH 22, 2024
Explore the three major mistakes commonly made in clinical operations that impact patient care, clinical research, and data integrity. Learn how to avoid these pitfalls for successful clinical operations.
Teladoc Health files patent for personalized care program for telehealth platform
Pharmaceutical Technology
MARCH 22, 2024
Discover how Teladoc Health Inc. is revolutionizing telehealth with a patented method to personalize care programs. Learn about the innovative segmentation model, interactive content, and enhanced user experience.
The New Age of Decentralized Clinical Trials
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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
Lilly CEO reaffirms commitment to Chinese market amid US threat against local biotechs
Fierce Pharma
MARCH 22, 2024
At a time of heightened geopolitical tensions between the U.S. and China, Eli Lilly’s CEO said the Indianapolis-based company remains committed to the Chinese market. | David Ricks’ visit to China comes as Lilly has several key drug applications under review at local regulators.
Biogen files patent for classification of brain lesions based on single point imaging
Pharmaceutical Technology
MARCH 22, 2024
Discover how Biogen Inc.'s patent revolutionizes brain lesion classification with single-point imaging. Learn about the innovative method and system for accurate and efficient results.
Top 12 Foods with the Most Pesticides
XTalks
MARCH 22, 2024
In the quest for healthier eating habits, it’s crucial to consider not just what we eat, but how our food is grown. The Environmental Working Group (EWG) has once again spotlighted this issue with its 2024 Shopper’s Guide to Pesticides in Produce, revealing the foods with the most pesticides. The “Dirty Dozen” list serves as a stark reminder of the prevalence of pesticides in our produce aisles.
Purdue Pharma files patent for purifying noroxymorphone by preparing and isolating bisulfite adduct
Pharmaceutical Technology
MARCH 22, 2024
Discover Purdue Pharma's innovative patent for purifying noroxymorphone through a unique process involving bisulfite adduct formation and regeneration. Learn about the applications and benefits of this purified compound in pharmaceuticals.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Heart claims unlock Medicare coverage of obesity drugs
pharmaphorum
MARCH 22, 2024
Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.
Ironwood Pharmaceuticals files patent for delayed release pharmaceutical composition containing linaclotide
Pharmaceutical Technology
MARCH 22, 2024
Discover Ironwood Pharmaceuticals' innovative patent for delayed release pharmaceutical compositions with linaclotide. Learn about the unique design and targeted therapeutic effects for gastrointestinal disorders.
Digital diabetes tools ‘of little benefit and raise costs’
pharmaphorum
MARCH 22, 2024
First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs
Ascendis Pharma files patent for ocular drug delivery system using cross-linked Ha
Pharmaceutical Technology
MARCH 22, 2024
Discover Ascendis Pharma's innovative patent for hydrogel prodrug compositions using cross-linked hyaluronic acid to treat ocular conditions. Learn about the groundbreaking method for administering the drug conjugate and its potential impact on treating AMD, DR, RVO, and more.
The New Age of Decentralized Clinical Trials
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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.
Idorsia first-in-class hypertension drug gets FDA okay
pharmaphorum
MARCH 22, 2024
Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist class for that indication.
Verastem files patent for combination treatment of FAK inhibitor and immunotherapy for cancer
Pharmaceutical Technology
MARCH 22, 2024
Discover how Verastem Inc.'s patent combines FAK inhibitors with immunotherapeutic agents like anti-PD-1 to enhance cancer treatment efficacy in humans. Explore the innovative method targeting immune checkpoint blockade pathways.
PAP 2024: Amy Niles Discusses Goals of the PAN Foundation
Pharmaceutical Commerce
MARCH 22, 2024
In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, The PAN Foundation discusses the overall mission of the organization.
Chinook Therapeutics files patent for improving kidney function in a subject
Pharmaceutical Technology
MARCH 22, 2024
Discover the groundbreaking patent by Chinook Therapeutics for improving kidney function in IgA nephropathy patients. Learn about the innovative methods and dosages for effective treatment.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Mirador’s massive $400m first round, and other financings
pharmaphorum
MARCH 22, 2024
It has been a bumper week for biotech financings, with a $400m Series A for Mirador heading, topping impressive rounds for Capstan, Clasp, Engrail, Enliven, and Nouscom.
AnGes files patent for crispr-based method for modifying mutant lRRK2 gene in cells
Pharmaceutical Technology
MARCH 22, 2024
Discover how AnGes Inc. is revolutionizing Parkinson's disease treatment with RNA molecules and CRISPR technology. Learn about their patent for precise genetic modifications.
Claudia Zylberberg on her cell and gene industry triumphs and ISCT hopes
BioPharma Reporter
MARCH 22, 2024
Dr. Claudia Zylberberg is a scientist and founder, board member and former CEO of Akron Biotech, a company that makes materials and technologies to support advanced therapy development.
Lisata clinches rare disease status for osteosarcoma drug
Pharmaceutical Technology
MARCH 22, 2024
Lisata Therapeutics announced a rare pediatric drug designation for LSTA1, which is being studied in several early to mid-stage clinical studies.
How Machine Learning Drives Clinical Trial Efficiency
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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.
FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat
pharmaphorum
MARCH 22, 2024
Italfarmaco’s non-steroidal drug Duvyzat (givinostat) has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD)
Trend report: how the market for prefilled syringes is evolving in 2024 (and beyond)
Pharmaceutical Technology
MARCH 22, 2024
Today’s prefilled syringe market is set for rapid growth due to advancements in auto-injector technology. Can CDMOs keep up with demand?
Innovate UK awards ten projects over £6m to develop new clinical tools for dementia
Pharma Times
MARCH 22, 2024
Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year
Pharmaceutical consulting companies, pharmaceutical training and other development services
Pharmaceutical Technology
MARCH 22, 2024
Download our free list of leading pharmaceutical consulting companies and training providers to make an informed purchasing decision.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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