Sun.Jul 21, 2024

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Health ministry issues draft rules for compounding of certain offences under drug regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union health ministry has issued a draft notification framing the rules related to compounding of offences for minor offences under the drug regulations.

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Rusan Pharma’s API Plant in Ankleshwar Receives USFDA GMP Approval

Pharmaceutical Technology

Rusan Pharma's new facility in India will enhance its global capabilities and expand its API product portfolio.

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Scientists Found an Alarming Pattern in The Brains of Sleep-Deprived Kids

AuroBlog - Aurous Healthcare Clinical Trials blog

Shorter sleep and later bedtimes are linked to potentially harmful functional changes to parts of the brain important for coping with stress and controlling negative emotions, our recently published research found. And children in families with low economic resources are particularly at risk.

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Medios sees highest patent filings and grants during May in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Medios here.

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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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Prenatal Cannabis Use and Maternal Pregnancy Outcomes

JAMA Internal Medicine

This cohort study examines the association between prenatal cannabis use and maternal health outcomes during pregnancy.

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Oscotec sees highest patent filings and grants during June in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Oscotec here.

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Dechra Pharmaceuticals sees highest patent filings and grants during May in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Dechra Pharmaceuticals here.

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Understanding the Patent Trial and Appeal Board (PTAB) – A Comprehensive Overview

Drug Patent Watch

The Patent Trial and Appeal Board (PTAB) is a crucial component of the United States Patent and Trademark Office (USPTO), established in 2012 by the Leahy-Smith America Invents Act (AIA).

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Oramed Pharmaceuticals sees highest patent filings and grants during April in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Oramed Pharmaceuticals here.

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Can Artificial Intelligence Speak for Incapacitated Patients at the End of Life?

JAMA Internal Medicine

This Viewpoint examines how artificial intelligence could support surrogate decision-makers while addressing some of the attendant epistemic and moral challenges.

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

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Y-mAbs Therapeutics sees highest patent filings and grants during June in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Y-mAbs Therapeutics here.

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Management of Elevated Blood Pressure in the Hospital—Rethinking Current Practice

JAMA Internal Medicine

This Clinical Insight proposes a new framework for managing asymptomatic blood pressure elevation in the hospital setting.

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Orion sees highest patent filings and grants during May in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Orion here.

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Lilly Wins Chinese Approval for Tirzepatide in Obesity on Heels of Novo’s Semaglutide

BioSpace

Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country.

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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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Medicover sees highest patent filings and grants during May in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Medicover here.

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Samsung Bioepis Gets FDA Approval for Biosimilar to AstraZeneca’s Soliris

BioSpace

The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.

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Kiniksa Pharmaceuticals sees highest patent filings and grants during April in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Kiniksa Pharmaceuticals here.

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Accelerated Chest Pain Treatment With Artificial Intelligence–Informed Triage

JAMA Internal Medicine

This quality improvement study evaluates the use of artificial intelligence to accelerate triage of patients presenting to the emergency department with chest pain.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Certara sees highest patent filings and grants during June in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for Certara here.

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Which pharmaceutical drugs have the most drug patents in Austria?

Drug Patent Watch

This chart shows the drugs with the most patents in Austria. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

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iTeos Therapeutics sees highest patent filings and grants during May in Q2 2024

Pharmaceutical Technology

Access and buy GlobalData’s databook on the latest filings and grants activity for iTeos Therapeutics here.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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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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Stand by Your Case? Without Standing, Supreme Court Precedent Means You’ll Have More Bad Times than Good

FDA Law Blog

By John W.M. Claud — Sometimes it’s difficult to be a plaintiff, putting all your work into just one case. That’s especially true if recent Supreme Court rulings have rendered your matter a quixotic pursuit, doomed to fail for lack of direct causation. That’s what happened last week in District Court in Maryland. Following the precedent on standing that the Supreme Court handed down in June in FDA v.

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