STAT

FEBRUARY 5, 2023

As a doctor, I have dedicated my life to saving the lives of others. But as a gay doctor, I have long been unable to do one simple thing that saves lives: donate blood. For more than 30 years, policies in the United States have banned gay and bisexual men from donating blood. That could change — ending decades of discrimination — if the Food and Drug Administration’s newly announced proposal for blood donation is made permanent.

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FDA 98

Roots Analysis

FEBRUARY 5, 2023

Modified T-cell receptors or TCR therapies is an emerging class of adoptive therapy that employs genetically modified lymphocytes to target specific tumor markers. Structurally, TCR is a heterodimer comprising of two different polypeptide chains, namely the α-chain and β-chain. TCR therapies’ tumor-cell killing efficacy may be primarily attributed to the fact that they are pre-sensitized to cancer specific antigens; this enables such interventions to selectively target and eliminate tumor

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The FDA Law Blog

FEBRUARY 5, 2023

By Faraz Siddiqui — In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts ). The drug makers argued that their statutory obligation to provide discounts did not extend to multiple contract pharmacies, who they said often abused the system.

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Med Ed 101

FEBRUARY 5, 2023

With some help from some great students, I have put together a few hundred free nursing pharmacology questions. There is no sign up required. I just wanted to provide a resource to my nursing friends! Even if you aren’t a nurse, this may be a great refresher and/or confidence builder if it has been a […] The post Free Nursing Pharmacology Questions appeared first on Med Ed 101.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

PharmaShots

FEBRUARY 5, 2023

Shots: The P-III (SUNSHINE) and (SUNRISE) trials evaluating Cosentyx (300mg, q2w/q4w) vs PBO in 545 & 544 patients across 40 countries In both trials, patients treated with Cosentyx (300mg, q2w) achieved HiSCR (45.0% vs 33.7%) & (42.3% vs 31.2%) @16wks., Cosentyx (300mg, q4w) was superior to PBO (46.1% vs 31.2%) & (41.8% vs 33.7%) Treatment response rates continued to improve beyond the 1EPs analysis @16wk., 55% achieved a HiSCR measure @52wk., ≥60% were free of flares, ≥50% re

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Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies

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FDA Adverse Reactions Chemotherapy Labelling 105