Tue.Apr 08, 2025

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t

FDA
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Unique pain research office eliminated in HHS purge

STAT

Last week’s layoffs across the Department of Health and Human Services left a significant casualty in the vast ecosystem of government-backed science: an entire division focused on researching pain.  The reduction in force enacted last week by Health Secretary Robert F. Kennedy Jr. eliminated all but one full-time position, out of roughly a dozen, within the National Institutes of Health Office of Pain Policy and Planning, a unit devoted to coordinating pain-related research across t

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Greener Pharmacy Guide and Toolkit launched by RPS to support sustainability

Hospital Pharmacy Europe

A digital self-assessment tool designed to help hospital pharmacy teams take practical action to support sustainability and reduce the environmental impact of pharmacy services, pharmaceutical care and medicines, while supporting patient care, has been launched by the Royal Pharmaceutical Society (RPS). The long-awaited RPS Greener Pharmacy Guide and Toolkit provides prompts to introduce more sustainable practices to reduce emissions, improve patient care, prevent ill health, tackle medicines wa

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Does NuvaRing make you gain weight?

The Checkup by Singlecare

If you’re looking for an effective contraceptive method without the hassle of taking medicine daily, your healthcare provider may recommend an alternative method of birth control like NuvaRing (etonogestrel-ethinyl estradiol). The hormonal contraceptive is a flexible ring that is inserted in the vagina once every four weeks to prevent pregnancy.

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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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GSK to advance antibody medicines for neurodegenerative diseases

European Pharmaceutical Review

GSK has agreed to develop novel medicines for neurodegenerative diseases, as part of a global licensing agreement with ABL Bio Inc, for up to 2.075 billion. This is subject to certain milestone payments across multiple potential programmes.The licensing deal will utilise ABL Bios blood-brain barrier shuttle platform Grabody-B, to advance multiple programmes across therapeutic modalities including antibody , polynucleotide or oligonucleotides, such as siRNA and ASOs.

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Opinion: Personal choice has been weaponized to undermine public health

STAT

I recently came across a reel on Instagram that I haven’t been able to stop thinking about since I saw it. A pastor in Texas stood before his congregation and proudly announced that their school had the lowest vaccination rate in the state. With balloons and celebratory T-shirts, he praised their community for what he called “freedom of health.

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STAT+: As more patients get automated test results, researchers seek ways to calm their nerves

STAT

Editor’s note: This story contains a description of self-harm. Oncologist Mark Lewis has never had much of a poker face. When he walked into his cancer patient’s visit in 2022, he was wearing a big smile: The nodules in his patient’s lungs, he saw in the radiology report, were shrinking in response to treatment. His patient, though, was already upset.

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High Force Research appoints Nathalie Huther as chief commercial officer

Pharmafile

High Force Research has announced that it has appointed Nathalie Huther as its first chief commercial officer (CCO) following the companys recent management buyout (MBO). This forms an important part of its business development and market expansion strategy. Huther will lead High Forces research commercial strategy, and brings a wealth of experience in commercial leadership […] The post High Force Research appoints Nathalie Huther as chief commercial officer appeared first on Pharmafile.

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STAT+: RFK Jr.’s Senate hearing delayed, living with more measles

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. STAT is cutting the price of an annual subscription in half. Click here for details , and send news and tips to John.Wilkerson@statnews.com or via Signal at John_Wilkerson.07.

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ELRIG appoints Del Trezise as chair

Pharmafile

ELRIG, a non-profit volunteer-led organisation dedicated to the drug discovery community, has appointed Del Trezise as chair of the board. He succeeds Melanie Leveridge, who completed her four-year term as chair. He will lead ELRIGs mission to deliver highly accessible scientific meetings and conferences. It serves a global network of over 22,000 life sciences professionals. […] The post ELRIG appoints Del Trezise as chair appeared first on Pharmafile.

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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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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Process analytical technology (PAT), namely at-line, online or inline instruments, may be represented by univariate sensors or more complex analysers and systems resulting in multivariate datasets. These can be pivotal for achieving high precision, efficiency and control, as well as continuous and automated manufacturing. Here we provide an overview of the tasks involved in implementing PAT in a GMP environment, as well as opportunities for organisations to consider in the face of common challen

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STAT+: With Trump review, a Harvard infectious disease researcher stands to lose it all

STAT

Tuberculosis infects more than a quarter of the world’s population, kills more than 1 million people per year, and is still a scourge at home. It has never disappeared from the United States, and there was even a recent cluster of cases in Boston, according to  Sarah Fortune , a Harvard scientist leading one of the world’s preeminent tuberculosis research programs.

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Environmental Factors Impact Psoriasis Severity

Drug Topics

In a comprehensive review, researchers aimed to explore seasonality, environmental factors, and the genetic and epigenetic mechanisms of patients living with psoriasis vulgaris.

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STAT+: Pharmalittle: We’re reading about a plan to boost U.S. biotech funding, FDA user fees, and more

STAT

Top of the morning to you, and a fine one it is. Blue skies and comfortable breezes are enveloping the Pharmalot campus, where the official mascots are dozing in their respective corners and assorted wildlife can be seen bounding about the grounds. As for us, we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today is pecan bourbon) and foraging for items of interest.

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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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Atopic Dermatitis May Increase Risk of Food Allergies

Drug Topics

In a review of skin inflammations link to food allergen sensitivity, researchers explored how patients with atopic dermatitis may be more susceptible to the development of food allergies.

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Cartesian’s CAR-T may help autoimmune patients long term

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. I’m writing to you from San Diego, where STAT held an event during the American Academy of Neurology annual meeting this past weekend. We’ll get into a highlight from the event below, along with all the other biotech news today.

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Data Remain Unclear Between Asthma Incidence, Prevalence, and COVID-19

Drug Topics

Conflicting study findings show various associations between asthma and COVID-19; further data are needed.

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AAN 2025: APP Care Models Can Be a Solution to Promoting Patient Access and Equity Within the Neurology Space

Pharmacy Times

Advanced practice provider (APP) care models allow for health systems to better individualize care for patients, effectively meeting their needs.

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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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GLP-1 Therapy May Reduce Dementia Risk

Drug Topics

Further studies are needed to further confirm the association between glucagon-like peptide 1 medication and reductions in dementia risk.

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AAN 2025: Tolebrutinib Shows Promise in Slowing Disability Progression for Secondary Progressive Multiple Sclerosis

Pharmacy Times

The HERCULES trial demonstrates tolebrutinib's potential to slow disability progression in non-relapsing secondary progressive multiple sclerosis, offering a new treatment option for patients with limited therapeutic choices.

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Drug Advertising Expert on FDA’s Boxed Warning Labels

Drug Topics

In part 3 of our interview with Jenny Markell, BA, she discussed drug advertising trends among Alzheimers disease drugs and how FDA suggestions are not necessarily followed.

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Study Finds ADHD Stimulants Have Minimal Effect on Cardiovascular System

Pharmacy Times

Small changes in blood pressure and pulse were shown in patients of all ages, and the authors suggested that these are monitored carefully in patients being treated for ADHD.

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Cognitive Behavioral, Mindfulness Therapies Reduce Daily Dosage of Opioid Use for Chronic Back Pain

Drug Topics

There were no statistically significant differences between cognitive behavioral therapy and mindfulness-based therapy in reducing the dosage for chronic lower back pain.

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Bortezomib Off-Week Regimen Shows Promise for Reducing Toxicity in Multiple Myeloma

Pharmacy Times

Erin Harrell, PharmD, offers insights about managing peripheral neuropathy in patients receiving bortezomib.

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Her son’s DMD diagnosis shook her world. As a biotech CEO, it was also an epiphany for better rare disease R&D.

PharmaVoice

Five years ago, Michelle Werner received her son’s Duchenne muscular dystrophy diagnosis with fear and desperation. Now, as CEO of Alltrna, she’s finding ways to turn those feelings into a better way of treating rare diseases.

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Nivolumab Plus Ipilimumab Receives FDA Approval for MSI-H/dMMR mCRC

Pharmacy Times

The approval was based on efficacy and safety data from a randomized, 3-arm, open-label phase 3 CHECKMATE-8HW trial.

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Ethris and Lonza to develop mRNA vaccines for respiratory conditions

Pharmaceutical Technology

Ethris has partnered Lonza for the development of room-temperature stable mRNA vaccine candidates targeting respiratory conditions.

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EU due to meet with pharma today to discuss tariffs

pharmaphorum

European Commission President Ursula von der Leyen is scheduled to meet with EU pharma leaders today about how to respond to US tariffs.

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EC approves extension of indication for Janssen-Cilag’s Darzalex

Pharmaceutical Technology

The European Commission (EC) has granted approval for the extension of indication for Janssen-Cilag Internationals Darzalex SC formulation.

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Rinvoq cleared for giant cell arteritis in EU, ahead of US

pharmaphorum

AbbVie has picked up another indication for its JAK inhibitor Rinvoq in the EU, becoming the first approved oral therapy for giant cell arteritis

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Fierce Healthcare - Untitled Article

Fierce Healthcare

Consumers are using their insurers' websites, mobile apps and other digital platforms in greater numbers, but their experiences often fall short of expectations, according to a new report.

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Are Republicans changing course on Medicare Advantage?

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning. In case you missed it yesterday, we have a winner for this year’s STAT Madness competition. From the same institution as last year — is that a dynasty I see forming?

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FDA nod broadens use of Brainomix's stroke AI

pharmaphorum

Brainomix has been granted FDA approval for a new feature for its AI-powered stroke imaging software that could unlock wider use in the US.

FDA