Thu.May 15, 2025

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Opinion: I was a Theranos whistleblower. Here’s what I think Elizabeth Holmes is up to

STAT

I always knew Elizabeth Holmes would have a second act. But I’m shocked it’s starting while she’s still behind bars. Elizabeth is now serving an 11-year sentence for defrauding investors in Theranos and has been banned from participating in federal health programs. The company was built on her claim that, at 19 years old, she had invented a device capable of running hundreds of tests from just a single drop of blood.

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A new CFO tasked with taking ‘scrappy’ Editas from last year’s layoffs into new gene editing territory

PharmaVoice

Amy Parison, who stepped into the lead financial role at the company in March, is managing Editas Medicine’s transition to a new gene editing platform while recovering from a major overhaul.

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STAT+: As AI in health care proliferates, so do legal questions concerning its use

STAT

SAN FRANCISCO — Lurking beneath the shiny promise of artificial intelligence in health care is a host of potential liability issues. Chief among them: a lack of consent from patients, whether any doctor checks the machine’s work, and, if they do, whether that even helps.  A panel of legal and medical experts at STAT’s Breakthrough Summit West explained the myriad legal questions hanging over the adoption of AI in health care.

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AviadoBio opens UK trial for FTD gene therapy

Pharma Times

Aspire-FTD study aims to stop disease progression with one-time treatment

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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STAT+: FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks

STAT

WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine makers, focused primarily on Covid-19 shots, in the coming weeks.  “We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry,” Makary said at the Food and Drug Law Institute conference on Thursday.

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STAT+: What to know about Summit Therapeutics’ looming clinical trial readout

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. Summit Therapeutics’ China vs. U.S. data showdown Dare I call it the most important study readout coming this summer? I’m referring to the pending announcement of the first clinical data from Summit Therapeutics and its buzzy PD-1-VEGF antibody ivonescimab derived from lung cancer patients in the U.S. and othe

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FDA delays approval decision for Biohaven rare disease drug

BioPharma Dive

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.

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Everything you need to know after RFK Jr.’s day on Capitol Hill

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! Despite believing that headlines on STAT stories are “terrible,” former FDA head Robert Califf said at yesterday’s Summit that we’re “providing a tremendous service right now to the country by really interrogating what’s been called radical transparency.

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FDA awards cancer drug approvals to AbbVie and MSD

Pharmaceutical Technology

The FDA has approved MSDs Welireg for rare adrenal tumours, and AbbVies Emrelis for treating c-Met+ lung cancer patients.

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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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STAT+: An RFK Jr. doubleheader and a very long Medicaid markup

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. Spare a thought for the House lawmakers and staff on two committees who suffered through markups that ran through the night.

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EMCrit 1:1 Nursing 001 – An Easy Case of Sepsis

EMCrit Project

Our first episode uses a simple case to act as touch-point for a discussion of resus nursing in the ED. EMCrit Project by Scott Weingart, MD FCCM.

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CMS and ASTP make broad health tech info request 

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. Good morning health tech readers!

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Sanofi pledges a $20 billion investment programme in the US

pharmaphorum

Sanofi is the latest European pharma group to promise a big capital investment programme on manufacturing and R&D in the US

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Putting in the Work: How to Take Back Control of Your Career Development

The Script

Want to grow your pharmacy career? Learn how to take charge through continuous learning, networking, mentorship, and goal settingwith support from Rx relief.

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Delivering NHS pharmacy services 'could pay for a new staff member'

The Pharmacist

Delivering nationally-commissioned NHS pharmacy services could generate enough income to pay the wages of an additional staff member, Community Pharmacy North East London chief executive has suggested. Delivering just 20 NHS consultations each week could generate as much as 451.70, Shilpa Shah told contractors this week at the Sigma 2025 conference in Baku, Azerbaijan.

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Drug Patent Research: Expert Tips for Using the FDA Orange and Purple Books

Drug Patent Watch

"Unlocking the Secrets of the FDA's Orange and Purple Books: Insider Tips from a Drug Patent Research Expert As the pharmaceutical industry continues to evolve at breakneck speed, staying ahead of the curve requires more than just a keen eye for innovation it demands a deep understanding of the regulatory landscape. For those in the know, the FDA's Orange and Purple Books hold the key to unlocking the secrets of the industry's most closely guarded information.

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AbbVie bags first approval for cancer ADC Emrelis

pharmaphorum

AbbVie has claimed its first global regulatory approval, from the FDA, for its C-met-targeting lung cancer ADC Emrelis

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Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

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STEERLife announces its solvent-free melt fusion technology

Express Pharma

STEERLife, the life sciences division of STEER World, is advancing the development and manufacturing of potent and complex drug products. At the core of this advancement is STEERLife’s solvent-free melt fusion technology, a continuous processing system that eliminates the need for harmful organic solvents. Designed to handle high-potency and hard-to-develop molecules, this platform significantly enhances formulation efficiency, safety, and scalability.

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AbbVie stakes $335M on a startup’s RNAi drugs

BioPharma Dive

ADARx Pharmaceuticals will work with AbbVie to make RNA interference medicines for a variety of disease areas, including neurology, immunology and cancer.

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Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Big Molecule Watch

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district courts dismissal of AstraZenecas challenges to the Inflation Reduction Acts Drug Price Negotiation Program and CMSs Guidance implementing the Program. AstraZeneca manufactures Farxiga, one of the drugs selected in the first round of drug price negotiations under the Program.

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Lupin gains USFDA approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg

Express Pharma

Lupin announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. This product will be manufactured at Lupins Aurangabad facility in India.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

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.

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Themes Among Rare Disease Repurposing Efforts

Pharmaceutical Commerce

A qualitative study aimed to strengthen systematic repurposing efforts within rare disease nonprofit organizations, while also providing a framework for data-driven drug repurposing.

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Kaerus Bioscience secures FDA approval for rare genetic disorder treatment

Pharmafile

Kaerus Bioscience announces that its lead candidate KER-0193 has been granted both Orphan Drug Designation (ODD) and Rare Pediatric Drug Designations (RPDD) for the treatment of Fragile X syndrome (FXS) by the US Food and Drugs Administration (FDA). Created by Medicxi, the global biopharma is focused on the development of therapeutics for rare genetic syndromes […] The post Kaerus Bioscience secures FDA approval for rare genetic disorder treatment appeared first on Pharmafile.

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Do White Papers Still Work in Pharma Marketing?

Pharma Marketing Network

In a world of podcasts , reels, and AI-written content, its fair to ask: are white papers still pulling their weight in pharma marketing? For teams navigating omnichannel campaigns, strict MLR approvals, and buyer fatigue, the answer isn’t just “yes”it’s if done right, they work better than ever. Once the domain of technical audiences and B2B legacy brands, white papers have evolved.

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The Connection Between UTIs and Hashimoto’s

The Thyroid Pharmacist

If youre a woman, its likely that youve experienced a urinary tract infection (UTI) at some point in your life. Some of us might even experience them more frequently than wed like (if thats you keep reading!). Between 50 and 60 percent of women will experience at least one UTI in their lifetime, and the prevalence of UTIs increases as we age. [1] In fact, its the most common outpatient infection in the U.S.

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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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​Why Competitive Intelligence still needs the human edge 

Fuld & Company Blog

Strategic Consortium of Intelligence Professionals (SCIP) ‘s IntelliCon in New Orleans was largely devoted to understanding Competitive Intelligence (CI) in an AI world, as well as the role of primary research. My assessment of both the conference and the intelligence landscape is a contradictory one, with two forces at work: ”Disruptive innovations create jobs, whereas efficiency innovations destroy them.” Clay Christensen “The more things change, the more they stay th

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Neogap Therapeutics selected to join EIC Soft-landing Programme, supporting international growth

Pharmafile

Swedish biotech company, Neogap Therapeutics, has been selected to participate in the EIC Soft-landing Programme for Healthcare and Life Sciences in Boston, US. Alongside other major biotech companies, it will showcase its technology to investors and potential partners, strengthening its presence in the US pharma market. Organised by the European Innovation Council, the EIC Soft-landing […] The post Neogap Therapeutics selected to join EIC Soft-landing Programme, supporting international g

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AbbVie and ADARx to develop siRNA therapeutics for multiple disease areas

Pharmaceutical Business Review

Under the agreement terms, AbbVie will pay ADARx an upfront of $335m, and the latter is also said to be qualified for additional payments. These include option-related fees, milestone payments, and tiered royalties. AbbVie noted that siRNA therapeutics signify a class of molecules to regulate gene expression and the production of protein. These molecules are tailored to target messenger RNA (mRNA) that encodes disease-causing proteins, thereby preventing their production.

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