Fri.Mar 22, 2024

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Unleashing Innovation: The Case for Permissionless R&D in Pharma

Drug Patent Watch

A recent article in Communications of the ACM explores opportunities for “Permissionless innovation” in pharmaceuticals.

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FDA clears first-of-its-kind Duchenne drug for broad use

Bio Pharma Dive

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.

Drugs 312
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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.

Insulin 264
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Medicare to cover Novo’s obesity drug for some patients

Bio Pharma Dive

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.

Drugs 173
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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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FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

Pharmaceutical Technology

The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

Antibody 244
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Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Fierce Pharma

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.

Insulin 128

More Trending

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Italfarmaco nabs FDA approval for new Duchenne med, teeing up sparring match with Sarepta

Fierce Pharma

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.

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Italfarmaco secures FDA approval for Duchenne muscular dystrophy drug

Pharmaceutical Technology

The FDA has approved Duvyzat for Duchenne muscular dystrophy patients aged six years and above.

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Innovate UK awards ten projects over £6m to develop new clinical tools for dementia

Pharma Times

Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year

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Innate shelves lacutamab monotherapy plans in peripheral T cell lymphoma

Pharmaceutical Technology

A combo trial will continue as planned in addition to the biotech’s cutaneous T Cell lymphoma programme.

Trials 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Four international teams awarded £4.7m to investigate heart and circulatory diseases

Pharma Times

These types of conditions are responsible for 25% of all UK deaths and affect 7.

Research 121
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Pharmaceutical consulting companies, pharmaceutical training and other development services

Pharmaceutical Technology

Download our free list of leading pharmaceutical consulting companies and training providers to make an informed purchasing decision.

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The 3 biggest mistakes we keep making in clinical operations

pharmaphorum

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.

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Pharmaceutical drug delivery market and systems

Pharmaceutical Technology

Download our free, comprehensive list of the leading companies within the pharmaceutical drug delivery market.

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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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Lilly CEO reaffirms commitment to Chinese market amid US threat against local biotechs

Fierce Pharma

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.

Marketing 119
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Vanda Pharmaceuticals files patent for treatment of psychiatric disorders with r-p88 once per day

Pharmaceutical Technology

Discover how Vanda Pharmaceuticals' patent for R-P88 offers a groundbreaking treatment for psychiatric disorders, simplifying dosing and administration for patients and healthcare providers.

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Digital diabetes tools ‘of little benefit and raise costs’

pharmaphorum

First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs

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Cellectis files patent for engineered T-cells for immunotherapy with inhibited B2M expression

Pharmaceutical Technology

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.

Engineer 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

pharmaphorum

Italfarmaco’s non-steroidal drug Duvyzat (givinostat) has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD)

Drugs 111
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Teladoc Health files patent for personalized care program for telehealth platform

Pharmaceutical Technology

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.

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Top 12 Foods with the Most Pesticides

XTalks

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.

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Biogen files patent for classification of brain lesions based on single point imaging

Pharmaceutical Technology

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.

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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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Heart claims unlock Medicare coverage of obesity drugs

pharmaphorum

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.

Drugs 105
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Purdue Pharma files patent for purifying noroxymorphone by preparing and isolating bisulfite adduct

Pharmaceutical Technology

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.

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PAP 2024: Amy Niles Discusses Goals of the PAN Foundation

Pharmaceutical Commerce

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.

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Ironwood Pharmaceuticals files patent for delayed release pharmaceutical composition containing linaclotide

Pharmaceutical Technology

Discover Ironwood Pharmaceuticals' innovative patent for delayed release pharmaceutical compositions with linaclotide. Learn about the unique design and targeted therapeutic effects for gastrointestinal disorders.

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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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Idorsia first-in-class hypertension drug gets FDA okay

pharmaphorum

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.

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AnGes files patent for crispr-based method for modifying mutant lRRK2 gene in cells

Pharmaceutical Technology

Discover how AnGes Inc. is revolutionizing Parkinson's disease treatment with RNA molecules and CRISPR technology. Learn about their patent for precise genetic modifications.

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Mirador’s massive $400m first round, and other financings

pharmaphorum

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.

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Ascendis Pharma files patent for ocular drug delivery system using cross-linked Ha

Pharmaceutical Technology

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.

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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.