Sun.Aug 11, 2024

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Three MDMA therapy papers retracted over data integrity concerns

STAT

The journal Psychopharmacology has retracted three papers about MDMA-assisted psychotherapy — right on the heels of the Food and Drug Administration’s rejection of the closely watched treatment for post-traumatic stress disorder. Many authors on the three studies are affiliated with the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and its commercial spinout Lykos Therapeutics, including founder Rick Doblin, who spearheaded the decades-long efforts to win a

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Benazepril Versus Lisinopril

Med Ed 101

Benazepril and lisinopril are both ACE Inhibitors that are commonly used in practice. Lisinopril is the most frequently used ACE inhibitor. In this article, we will compare benazepril versus lisinopril and highlight some of the differences that may help guide the selection of one versus the other. Angiotensin-converting enzyme (ACE) inhibitors are a specific medication […] The post Benazepril Versus Lisinopril appeared first on Med Ed 101.

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Opinion: Getting to ‘Plan B’ for psychedelic medicine: Lessons from reproductive health

STAT

The Food and Drug Administration’s decision not to approve Lykos Therapeutics’ application for MDMA (a psychedelic drug known on the street as Ecstasy or molly) plus therapy for post-traumatic stress disorder comes as no surprise, given an advisory panel’s “no” vote on the application in June. But if lessons from reproductive health are any signal, I believe there is a future for psychedelics in health care.

Bioethics 329
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Dr Reddy’s Labs gets US FDA clearance: Visakhapatnam facilities classified as VAI

Express Pharma

Dr Reddy’s Laboratories has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facilities, FTO-7 and FTO-9, in Duvvada, Visakhapatnam. The US FDA has classified the inspection as Voluntary Action Indicated (VAI), indicating that while observations were made, no immediate regulatory action is required.

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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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Opinion: Controlling obesity is a noble goal. Controlling mpox is a far more urgent one

STAT

As a global health investor and public health advocate, I understand the benefit of weight loss drugs and the rush to promote Ozempic, Wegovy, and other GLP-1 drugs. What I cannot wrap my head around is how, almost 45 years after the World Health Organization announced that smallpox had been eradicated , the world is once again dealing with smallpox vaccines and treatments, this time aimed at mpox.

Vaccines 315
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FDA shoots down Lykos' MDMA therapy for PTSD

pharmaphorum

The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psychedelic medicines category.

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How to ensure quality and compliance in clinical supply chain management

GMPSOP

How to ensure quality and compliance in clinical supply chain management Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Clinical supply chain management of investigational medicinal products ensures the overall success of introducing new drug molecules in the market. Stringent regulations govern clinical supply chain management for medicinal products, biologics, and medical devices during clinical trials.

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Episode 947: If anaphylaxis to sugammadex is so rare, why make such a big deal about it?

Pharmacy Joe

In this episode, I’ll discuss anaphylaxis to sugammadex. Episode 947: If anaphylaxis to sugammadex is so rare, why make such a big deal about it? Subscribe on iTunes , Android , or Stitcher The rate of anaphylactic reaction to the use of sugammadex is probably somewhere between 1 in 2000 and 1 in 4000 patients. This makes anaphylaxis to sugammadex probably 2-4 times more rare than anaphylaxis to rocuronium.

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Which pharmaceutical companies have the most drug patents in Malaysia?

Drug Patent Watch

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

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Otic Drug Delivery

RX Note

Introduction Ear preparations are usually placed in the ear canal by drops in small amounts for Removal of excessive cerumen (earwax) Treatment of ear infections, inflammation or preparation. Advantages Ability to achieve a local drug concentration much higher than what could be achieved via systemic administration. Also minimizing off-target systemic exposure.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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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 Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing

PharmaTech

The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.

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New patent expiration for Takeda Pharms drug NINLARO

Drug Patent Watch

Annual Drug Patent Expirations for NINLARO Ninlaro is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug.

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Integrating Strategies for Formulation Success

PharmaTech

Employing novel technologies and more patient-centric approaches can help to reduce the potential of formulation failure.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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The Role of Patent Attorneys in Generic Drug Development

Drug Patent Watch

The development of generic drugs is a crucial aspect of the pharmaceutical industry, as it provides affordable alternatives to expensive […] Source

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The Expanding Role of Continuous Glucose Monitors in Pregnant Patients

Pharmacy Times

The use of CGMs in pregnancy provides clinicians with essential data in real-time, rather than a snapshot given by traditional finger stick testing.

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How To Convince Physicians To Change Their Antibiotic Prescribing Practices: 5 Lessons From An Antimicrobial Stewardship Pharmacist

ID Stewardship

In this article an antimicrobial stewardship pharmacist discusses how to convince physicians to change their antibiotic prescribing practices Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 12 August 2024 Antimicrobial stewardship is about promoting the safe and rational use of antimicrobial agents. This goal can be achieved in many ways, but a key part of the effort needs to be getting physicians on board with prescribing practices that the antimicrobial stewardship progr