Sun.Dec 03, 2023

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Moving RNA Therapeutics Beyond the Liver

BioSpace

From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.

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Lilly's Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

Fierce Pharma

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. | As AbbVie and Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class with an accelerated approval in post BTK/BCL-2 chronic lymphocytic leukemia.

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Roche Jumps into Lucrative Weight-Loss Space with $2.7B Carmot Buy

BioSpace

The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity.

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Thirty years of the Patented Medicines (Notice of Compliance) Regulations

Pharma in Brief

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation in Canada.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lilly Wins Second Accelerated Approval for Reversible BTK Inhibitor

BioSpace

Lilly’s Jaypirca (pirtobrutinib) can now be used to treat chronic lymphocytic leukemia or small lymphocytic leukemia that had progressed from at least two prior lines of therapy, in addition to its previously-approved indications.

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Photobiomodulation Therapy to Treat Snakebites Caused by Bothrops atrox

JAMA Internal Medicine

This randomized clinical trial investigates the feasibility, safety, and efficacy of low-level laser therapy in reducing the local manifestations of Bothrops atrox envenomations.

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Which pharmaceutical drugs have the most drug patents in Spain?

Drug Patent Watch

This chart shows the drugs with the most patents in Spain. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Spain? appeared first on DrugPatentWatch - Make Better Decisions.

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AstraZeneca to Spend $247M in Collaboration with AI Discovery Outfit Absci

BioSpace

In the latest example of big pharma entering AI collaborations or using AI-based tools, AstraZeneca’s deal with Absci will aim to produce an oncology candidate.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

By Faraz Siddiqui & Alan M. Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit. As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”).

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EMA Requests More Data from GLP-1 Drugmakers in Suicidal Ideation, Self-Harm Probe

BioSpace

The European Medicines Agency is seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class.

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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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FDA Action Alert: Vertex/CRISPR, Arcutis and Optinose

BioSpace

This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.

Drugs 96
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EyePoint Pharma Stock Surges on Phase II Wet AMD-Therapy Results

BioSpace

EyePoint Pharmaceuticals’ treatment for wet age-related macular degeneration showed comparable results to Regeneron’s Eylea with a less frequent dosing regimen.

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J&J Hires Thousands, Invests Millions in AI-Powered Drug Discovery

BioSpace

Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.

Drugs 84
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Opinion: The Transformative Potential of Gene Therapy for Neurodegenerative D.

BioSpace

For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.

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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