STAT

OCTOBER 13, 2024

SalioGen Therapeutics, a company that raised $135 million to develop a new gene-editing technology, has instituted widespread layoffs and is scaling back its ambitions, according to a person familiar with the situation and employee posts on social media. It is the latest in a series of retrenchments by high-profile gene-editing companies. A spokesperson for SalioGen declined to comment.

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Safe Biologics

OCTOBER 13, 2024

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE – September 4, 2024 Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic medicines they c

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Biosimilars Documentation 100

pharmaphorum

OCTOBER 13, 2024

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year.Marstacimab will be launched as Hympavzi to treat haemophilia A without factor VIII inhibitors and haemophilia B without factor IX inhibitors in patients aged 12 and older and is the first drug in the anti-TFPI class to be approved in the US.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

By Mark A. Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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Documentation Drug Development 59

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PharmaTech

OCTOBER 13, 2024

This case study explores the deployment of an innovative logistics solution designed to support the survival of premature infants through the rapid collection, retrieval and delivery of essential, temp-sensitive supplements to hospitals in Sydney, Australia. Storage specifications for the supplements was -20°C with instant availability required upon order.

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Hospitals 52

Pharmacy Joe

OCTOBER 13, 2024

In this episode, I’ll discuss whether the bispectral index (BIS) correlates well to commonly used sedation scales. Episode 965: Does the bispectral index correlate well to commonly used sedation scales? Subscribe on iTunes , Android , or Stitcher Bispectral index is commonly used by anesthesia providers as a tool to ensure adequate loss of consciousness in the operating room and lessen the chance of accidental awareness during anesthesia.

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Inpatient 52

Med Ed 101

OCTOBER 13, 2024

The American Thyroid Association defines hypothyroidism as a result of an “underactive thyroid gland.” Common symptoms include fatigue, cold sensitivity, dry skin, weight gain, hair loss, high cholesterol, or constipation. The recommended treatment is replacing the body with T4 (levothyroxine). Currently, the guidelines recommend one standard treatment, but there are other options available.

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RX Note

OCTOBER 13, 2024

Introduction Following the removal of the Ring/Silent switch in favour of the Action button on the iPhone 15 Pro and iPhone 15 Pro Max, Apple introduces a new dedicated camera control button across all iPhone 16 models. While the addition aims to enhance the user experience for photography, its effectiveness remains debatable. The Practicality of Camera Control On previous supported iPhone models, users could customize the Action button to launch the camera or flashlight.

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