STAT

AUGUST 11, 2024

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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Express Pharma

AUGUST 11, 2024

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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STAT

AUGUST 11, 2024

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.

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Bioethics 332

Med Ed 101

AUGUST 11, 2024

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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STAT

AUGUST 11, 2024

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.

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Vaccines 318

pharmaphorum

AUGUST 11, 2024

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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Pharmacy Joe

AUGUST 11, 2024

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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Inpatient 52

Drug Patent Watch

AUGUST 11, 2024

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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RX Note

AUGUST 11, 2024

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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Dosage 52

Drug Patent Watch

AUGUST 11, 2024

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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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.

PharmaTech

AUGUST 11, 2024

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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Pharmaceutical Manufacturing 52

Drug Patent Watch

AUGUST 11, 2024

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

Drug Development 52

Drug Development 52

PharmaTech

AUGUST 11, 2024

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

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Pharmacy Times

AUGUST 11, 2024

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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Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

Drug Patent Watch

AUGUST 11, 2024

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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Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

AUGUST 11, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. The letters are vastly different from one another in subject matter, but together they make a cruel summer of OPDP enforcement against industry. [Editorial note – the Gen X’er included that link first – for the arguably more popular reference, read on.

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Labelling Communication 59

ID Stewardship

AUGUST 11, 2024

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

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Nursing Homes Inpatient Communication Hospitals 52