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As a cardiothoracic surgeon and former member of Congress, I’ve spent decades working to protect people’s health — first in the operating room, later in Washington. I’ve sat with worried parents. I’ve cared for patients at their most vulnerable. And I’ve always believed that public health decisions, especially those made by government, must be grounded in science, shaped by ethics, and made with the public’s trust in mind.
Turnover of the top execs at pharma giants like J&J, AbbVie and Merck in the last few years illustrates the seismic industry shifts that often accompany leadership changes.
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. It’s reality check time in biotech. A recovery from this prolonged and painful market downturn will require a major attitude adjustment from biotech management teams. For some especially troubled companies, that means voluntarily shutting down.
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.
WASHINGTON — The Make America Healthy Again commission’s first report on the nation’s health crisis is in, and it sounds familiar. The assessment, kept tightly under wraps before Thursday — the commission met just once , behind closed doors — lays out health secretary Robert F. Kennedy Jr.’s views, and gives some sense of where his department will target its efforts.
The Board of the Medicines and Healthcare products Regulatory Agency (MHRA) has met in Scotland for the first time, marking a significant step in the agencys approach to delivering health and innovation priorities across the UK.
Top of the morning to you. Gray skies are once again hovering over the soggy Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.
Top of the morning to you. Gray skies are once again hovering over the soggy Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.
In 2018, my daughter, Mila, became the first person in the world to receive a medicine designed for one person, an antisense oligonucleotide (ASO) called “ milasen.” Last week, the world received the breaking news that a baby named KJ had received the first personalized CRISPR treatment — one that may save his life. Just as technology is revealing thousands of genetic conditions behind previously unexplained symptoms, Mila and KJ’s stories are proving an entirely new
An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.
WASHINGTON — Lawmakers grilled Food and Drug Administration Commissioner Marty Makary on the agency’s new Covid-19 vaccine framework, the accidental firings of infant formula scientists, and the pace of regulatory approval for rare disease drugs at a Senate budget hearing on Thursday. Makary responded at times with frustration, refuting lawmakers’ reports of slow-downs at the agency and quibbling with them over his and health secretary Robert F.
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
Already a Vigil Neuroscience investor, Sanofi has agreed to buy the rest of the biotech’s shares for $8 apiece, representing a total deal value of $470 million.
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!
The Danish drugmaker unveiled a series of initiatives to increase access to Wegovy and clamp down on use of the knock-off versions that have dented its sales forecasts.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning! Sorry to write another blue box about food, but today’s item on the nutritional value of kids’ cereal is somehow making my stomach growl! I don’t eat cereal but if I did , it would be Cap’n Crunch.
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.
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.
This Memorial Day, you can get 50% off your first year of STAT+ and enjoy unlimited access to award-winning journalism, premium data tools, discounted event tickets, and much more. Tip jar: John.Wilkerson@statnews.com or over Signal at John_Wilkerson.07. Update on GOP Medicaid negotiations The House Rules Committee passed the budget reconciliation bill late Wednesday night, teeing it up for House floor action.
Digital physical therapy company Hinge Health went public Thursday morning, raising $437 million at a $2.6 billion valuation. The company is a crucial test case for whether digital health companies, for all their glitz and ambition, can produce real business results. CEO Dan Perez, who co-founded the company in 2014, knows that people are watching. After dozens of companies went public from 2020 to 2022, it’s been quiet for years.
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.
Biocon Biologics informs that the Government of Malaysia has agreed to extend the current contract period of 36 months under the existing insulin supply agreement with its subsidiary in Malaysia, Biocon, and Duopharma Marketing (DMktg), for an additional six months, effective from April 29, 2025, until October 28, 2025. Biocon Biologics has partnered with the Ministry of Health for its insulins requirements and has been serving patients in Malaysia for nearly 10 years.
Walton Oaks, 21stMay 2025Pfizer Ltd announced today that the National Institute for Health and Care Excellence (NICE) has published final draft guidance which recommends Hympavzi(marstacimab) as an option for preventing bleeding episodes in people 12 years of age and older, weighing at least 35 kg, with severe haemophilia B (congenital factor IX [9] deficiency, factor […] The post NICE recommends Pfizers new once-weekly treatment for haemophilia B on NHS appeared first on Pharmafile.
Venus Remedies has renewed its Good Manufacturing Practices (GMP) certification from Ukraine’s State Service on Medicines and Drugs Control (SMDC). The certification applies to the company’s Unit-II manufacturing facility located in Baddi, Himachal Pradesh, covering its cephalosporin, non-cephalosporin (carbapenem), and oncology parenteral production lines, including liquid and lyophilized injections.
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.
First-in-class therapeutic peptide BZ371A confirmed as effective and well-tolerated 20 May 2025. Another Day Pharma Ltd, a company developing innovative therapies for sexual dysfunction in both men and women, today announced Phase II results for its new treatment BZ371A in post-prostatectomy erectile dysfunction. Trial results show that BZ371A in gel form can improve mens ability […] The post Another Day Pharma announces successful Phase II trial results for BZ371A in post-prostatectomy er
"The Prescription Price Pinch: How 'March-In' Rights Could Revolutionize Your Medication Costs As the cost of prescription medications continues to skyrocket, a little-known provision in US law may hold the key to affordable healthcare for millions. 'March-In' rights, a provision of the Bayh-Dole Act, allows the government to step in and license patented technologies at a lower cost when they're deemed essential for public health.
This article Part 1 of a two-part series is a call to rethink biopharma strategy from the ground up. Well explore why legacy approaches fail, unpack how megatrends are rewriting the rules, and challenge leaders to rethink how we position, choose, execute, and govern in an exponential world.
Rethink DEI Without Losing Direction Pranil Thu, 05/22/2025 - 22:03 Many companies are scaling back their DEI efforts. Others are unsure of the path forward. But walking away risks more than reputational damage. It puts culture, trust, and long-term value at stake. This GEP bulletin helps leaders take stock of whats working, fix whats not, and reconnect DEI to real business priorities.
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.
Speaker Mike Johnson negotiated a number of last minute changes to the megabill to get it across the finish line, including moving up the start date for Medicaid work requirements.
Pharmacies have been advised that the brand Nystan 100,000units/ml oral suspension (ready mixed) (Vygoris Ltd)30 ml has been discontinued. The branded oral suspension, used for oral thrush, is no longer available for pharmacies to order and instead a generic Nystatin 100,000units/ml oral suspension should be ordered from wholesalers. The discontinuation raises potential price issues, as […] The post Nystan oral suspension discontinued appeared first on The Pharmacist.
Tiakis Biotech has announced the appointment of Christoph Schmidt to its supervisory board. Based in Kiel, Germany, the clinical-stage biotech company is developing therapies for life-threatening pulmonary and cardiovascular diseases, including pulmonary arterial hypertension (PAH). Schmidt brings nearly 30 years of global experience in the life sciences industry, having held senior roles at Actelion and […] The post Tiakis Biotech appoints Christoph Schmidt to supervisory board appeared f
Sanofi has agreed to acquire the biotech Vigil Neuroscience for a value of approximately $470 million.The neurology-focused deal will enhance Sanofis early-stage pipeline and includes the oral small molecule VG-3927, set to be investigated in a Phase II Alzheimers clinical trial. VG-3927 is an TREM2 agonist. Activation of TREM2 helps to prevent the neural degeneration associated with adult-onset neurodegenerative diseases.
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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