Tue.Feb 18, 2025

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7 foods to avoid while taking Jardiance

The Checkup by Singlecare

Jardiance (empagliflozin) is a brand-name prescription drug that has been FDA approved as a supplement to diet and exercise to improve blood sugar levels in people with Type 2 diabetes. It is also FDA-approved to treat chronic kidney disease (CKD) in those at risk of progression and reduce the risk of cardiovascular death in adults with either heart failure or Type 2 diabetes and cardiovascular disease.

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STAT+: Biogen partners with Stoke Therapeutics on drug for severe epilepsy

STAT

Biogen and Stoke Therapeutics have signed a partnership agreement to co-develop and sell Stoke’s experimental treatment for Dravet syndrome, a severe form of epilepsy, outside the U.S., the companies said Tuesday.  For Biogen, acquiring international commercial rights to the Stoke drug bolsters its rare disease and neurology pipeline, and provides another product that could help it return to growth in the latter part of the decade.

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What to Expect When you are Expecting…a Government Shutdown

The FDA Law Blog

By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.

FDA
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STAT+: Generic drugmakers win a long-running battle with California over a law to ban pay-to-delay deals

STAT

California officials were dealt a setback by a federal judge who ruled that a controversial law banning so-called pay-to-delay deals between pharmaceutical companies is, in part, unconstitutional and so cannot be enforced against agreements that had no link to the state. In his ruling , U.S. District Court Judge Troy Nunley determined that the state law, which was enacted in 2019, violated the Dormant Commerce Clause of the U.S.

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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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DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

The FDA Law Blog

By Andrew J. Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing.

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STAT+: XRHealth makes another acquisition, aiming to be a leading virtual provider using VR

STAT

XRHealth is on a shopping spree, buying three companies in as many years, as it aims to build a leading platform for therapeutic virtual reality. The latest: It’s acquiring RealizedCare, a company that couples immersive experiences with coaches for chronic pain management. XRHealth and RealizedCare own assets for a range of virtual reality headset-based experiences designed to help treat mental health, chronic pain, and other conditions.

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Abridge raises $250 million highlighting ‘billable notes’

STAT

Y ou’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Bill, baby, bill: Abridge announces $250 million raise Abridge announced a $250 million Series D fundraise co-led by investor Elad Gil and IVP with participation from many other notable venture firms.

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Cryotherapy Spray Reduced Pain, Improved Joint Mobility

Drug Topics

Patients with musculoskeletal pain were treated with cryotherapy spray to assess its use in providing immediate and sustained pain relief.

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CRISPR’s cardio catch-all drives a biotech’s broad potential

PharmaVoice

Scribe Therapeutics hopes to prevent cardiometabolic diseases by targeting underlying causes with CRISPR technology.

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Your 2025 Pharmacy Legislation Update

Drug Topics

Explore key legislative actions changing pharmacy practice in 2025 and beyond.

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Position Your Pharmacy for Expansion

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.

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CDC Study Raises Concerns Over Undetected H5N1 Infections in Humans

Pharmacy Times

Research suggests H5N1 may be spreading undetected among humans, particularly in veterinarians with frequent animal exposure.

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Deucravacitinib Safety, Efficacy for Plaque Psoriasis Remains Consistent Up to 5 Years

Drug Topics

The FDA initially approved deucravacitinib (Sotyktu) in September 2022 to treat moderate-to-severe plaque psoriasis.

FDA
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Children and Adolescents With Postacute COVID-19 Face Higher Risk of Poor Gastrointestinal Tract Outcomes

Pharmacy Times

New data from the longest known trial of pediatrics and adolescents in the postacute phase of COVID-19 show they are at a heightened risk of gastrointestinal tract symptoms.

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FDA Accepts sBLA for Dupilumab for Bullous Pemphigoid

Drug Topics

Previously, dupilumab (Dupixent) received orphan drug designation for bullous pemphigoid.

FDA
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

At ViVE 2025, digital health leaders reveal new generative AI products and industry cost savings reports. Here's a look at some quick hits from the show floor.

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Could SSRIs protect against infections? A mouse study has hints

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning, we’ve got a lot to go over. As one editor put it on Friday: “‘When it rains it pours’ doesn’t seem to adequately capture the deluge of news.

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FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid

Pharmaceutical Technology

As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.

FDA
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Fierce Healthcare - Untitled Article

Fierce Healthcare

The quarterly numbers are a dip from the year prior and come shortly after news of mass layoffs among nonclinical employees. Alongside more than $200 million of expected savings per year, management said the cuts would "improve efficiency" and "empower staff.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Can Dupixent plug treatment gap in bullous pemphigoid?

pharmaphorum

The FDA is scheduled to deliver a verdict on Sanofi and Regeneron's Dupixent for rare autoimmune skin disorder bullous pemphigoid in June

FDA
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Fierce Healthcare - Untitled Article

Fierce Healthcare

The order directs the Domestic Policy Council to make policy recommendations to protect IVF access and aggressively reduce the associated costs for treatment.

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New Study Puts Community Pharmacists at Forefront of Diabetic Kidney Disease Therapy

Pharmacy Times

Clinical decision support systems based on algorithms have improved outcomes and reduced costs in other health care settings.

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Four more drugs in keenly watched ALS trial miss the mark

pharmaphorum

ALS candidates from Biohaven, Prilenia, Clene, and UCB were unable to slow disease progression in the study, but two showed signs of efficacy

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Larsucosterol Did Not Show Statistical Significance Compared With Placebo in Phase 2b AHFIRM Trial

Pharmacy Times

Although larsucosterol did not show statistical significance, it showed clinically meaningful trends in 90-day mortality in patients with severe alcohol-associated hepatitis.

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First biosimilar fast-acting insulin reaches US market

pharmaphorum

Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog

FDA
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Sickle Cell Disease Management Requires Pharmacist Involvement in Multidisciplinary Care Team

Pharmacy Times

Prescribing and dosing appropriate treatments for patients with sickle cell disease while managing episodes of acute pain are some of the integral roles of pharmacists.

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Executives at Risant Health and Geisinger Health offered a look under the hood during a fireside chat at ViVE 2025 and shared details about the value-based "engine" that drives its work.

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Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use

Pharmaceutical Technology

The FDA has accepted Gileads new drug application with a decision expected by 19 June 2025.

FDA
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The Role of Collaborative Supply Chains in Improving Patient Outcomes

Pharmaceutical Commerce

In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on why she believes supply chain collaboration is becoming increasingly critical today.

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Biogen partners with Stoke Therapeutics to sell severe epilepsy drug

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. Today we take a closer look at what firings at U.S. health agencies mean for the country’s broader scientific enterprise. Also, a hearty congrats to my coworkers Bob Herman, Tara Bannow, Casey Ross, and Lizzy Lawrence, who won a Polk award — STAT’s third — for their coverage of UnitedHealth Group.

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Shionogi gets approval in Japan for ADHD digital therapeutic

pharmaphorum

Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator

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FDA grants fast track status to Rznomics’ RZ-001 for HCC

Pharmaceutical Technology

The US FDA has granted fast track designation to Rznomics' RZ-001 for the treatment of hepatocellular carcinoma (HCC).

FDA
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Tarlatamab-dlle: A Beginning for Bispecific Therapies in Small Cell Lung Cancer

Pharmacy Times

Second-line and later treatment options for small cell lung cancer are limited.

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HMRI and Novartis Australia sign MoU to expedite medical research

Pharmaceutical Technology

HMRI has signed a memorandum of understanding (MoU) with Novartis Australia for expediting medical research to drive healthcare projects.