FDA Law Blog: Biosimilars

OCTOBER 27, 2024

By Deborah L. Livornese & John W.M. Claud & Charles D. Snow — On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA.

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Drug Patent Watch

OCTOBER 27, 2024

A troubling trend has emerged in recent years, leaving both healthcare providers and patients grappling with an unexpected challenge: the persistent shortage of generic drugs in hospitals. This issue has far-reaching consequences, affecting patient care, hospital operations, and the broader healthcare system.

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Hospitals Drugs 98

Drugs.com

OCTOBER 27, 2024

MONDAY, Oct. 28, 2025 -- Halloween is meant to be a spooky season, but it can be downright terrifying to someone suffering from Alzheimer’s disease or dementia.“Halloween is full of scary sights and frightful sounds that create additional cha.

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Disease 98

Science Daily: Pharmacology News

OCTOBER 27, 2024

The warming climate in polar regions may significantly disrupt ocean circulation patterns, a new study indicates. Scientists discovered that in the distant past, growing inflows of freshwater from melting Arctic sea-ice into the Nordic Seas likely significantly affected ocean circulation, sending temperatures plummeting across northern Europe.

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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

Treatment

Codon

OCTOBER 27, 2024

This essay by Kamal Nahas is the first in a two-part series on tuberculosis. The second part — focused on vaccines and medicines — will be published next Sunday, concluding Issue 04 of Asimov Press. The Most Deadly Infectious Disease “Each successive episode of bleeding left him weaker than before,” wrote Mary Doria Russell of Doc Holliday, the gunslinging gambler, in her eponymous book, Doc.

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Immune Response Doctors Disease Laboratories 77

Covalent Modifiers

OCTOBER 27, 2024

Adrian L. Gill, Mathew A. Marx RAS Drug Discovery Past, Present and Future 2025 , 205-227 [link] Krazati (adagrasib/MRTX849) is a potent, selective, and covalent KRAS G12C inhibitor, representing a significant breakthrough in directly targeting KRAS. Adagrasib demonstrates favorable drug-like properties, selectively modifying mutant cysteine 12 in GDP-bound KRAS G12C , leading to the inhibition of KRAS-dependent signaling both in vitro and in vivo, and tumor regression in many KRAS G12C -positiv

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Clinical Trials Trials Drugs 68

Science Daily: Pharmacology News

OCTOBER 27, 2024

New research has revealed that species that are more social live longer and produce offspring for a greater time-span. This is the first study on this topic which spans the animal kingdom, from jellyfish to humans.

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Research 59

BioPharma Drive: Drug Pricing

OCTOBER 27, 2024

The startup claims its proprietary linker molecules can yield ADCs that are more precise and potent than existing options.

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Broad Institute

OCTOBER 27, 2024

C-ZIPTF: stable tensor factorization for zero-inflated multi-dimensional genomics data By Pinar Demetci October 27, 2024 C-ZIPTF: stable tensor factorization for zero-inflated multi-dimensional genomics data Neriman Tokcan Assistant Professor of Applied Mathematics University of Massachusetts, Boston Abstract: In this talk, we will delve into the challenges associated with tensor decompositions and present innovative models designed to tackle these obstacles effectively.

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RNA Research 52

Quanticate

OCTOBER 27, 2024

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans. These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years. Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United

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Clinical Trials Trials FDA Drugs 97

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Clinical Trials