Fri.May 26, 2023

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Some hoped a new oral vaccine would solve all the polio campaign’s problems. Reality is settling in

STAT

When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.

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The ‘superpowers’ pharma leaders should cultivate

PharmaVoice

Executives honored by the Healthcare Businesswomen’s Association share the key traits that help them drive results.

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Texas wants to wean trans youth off meds in a ‘safe and medically appropriate’ way. Doctors say that’s impossible

STAT

In a wave of anti-LGBTQ legislation , 19 U.S. states thus far have banned at least some gender-affirming health care for minors — care that is evidence-based and supported by the major medical and professional organizations. The state of Texas may soon add to that count, with legislators passing a bill last week that Governor Greg Abbott has promised to sign when it comes across his desk.

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Delivery pivotal as UK life sciences plan takes shape

Pharma Times

Life Sciences Council meeting hosted by chancellor Jeremy Hunt has unfolded in Downing Street

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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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Science finally figured out how to make effective RSV vaccines. Will seniors care?

STAT

The world has waited decades for vaccines to protect older adults against RSV. One, made by GSK, was approved by the Food and Drug Administration earlier this month. A second, made by Pfizer, is expected to follow by the end of May. Both will likely be in use this fall, in time to protect seniors going into the next RSV season. So it’s tempting to think the fight against respiratory syncytial virus in older adults is about to kick into high gear, that as early as next winter the United St

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Omada tackles obesity drugs, Boston Scientific nixes deal, and Microsoft health exec on GPT

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.  Omada Health  announced it will launch  a new service  to help employers respond to the soaring demand for  e xpensive GLP-1 weight loss treatments like Wegovy.

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3 FDA decisions that could be delayed if the U.S. defaults on its debt

PharmaVoice

If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.

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STAT+: Neuralink can now study its brain implant in humans, but it’s still catching up to its peers

STAT

Neuralink can now study its brain implant in humans after securing a go-ahead from the Food and Drug Administration. It’s a critical turning point for the Elon Musk-led company — but the startup, however closely watched, is playing catch-up compared to its peers in the neurotechnology field. “In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.

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Serial biotech founder Tim Springer on investing in startups and democratizing antibody research

BioPharma Dive

Springer, who became a billionaire after an early investment in Moderna, spoke with BioPharma Dive after gifting $210 million to his nonprofit institute in Boston.

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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+: Pharmalittle: EMA urges revoking authorization for Novartis sickle cell drug; U.K. tries to placate pharma execs

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we hope to check in on the Pharmalot ancestors, hang with our shortest person, promenade with the official mascot, and squeeze in a listening party — the rotation will include this , this , this and this.

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Elon Musk’s Neuralink says FDA has cleared human trial

pharmaphorum

Elon Musk’s Neuralink says FDA has cleared human trial Phil.

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Opinion: STAT+: An overlooked way to make participants in clinical trials look more like America

STAT

A recent report from the National Academies of Sciences, Engineering and Medicine (of which one of us, GC, is an author) shows that underrepresentation of population subgroups in clinical research is bad for the health of Americans. For instance, recent research showed that appropriate dosing for an often- prescribed blood thinner, warfarin, differs due to genetic variants.

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FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved 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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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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Priority review granted by FDA for 'landscape changing' colorectal cancer drug

Outsourcing Pharma

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

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Primary care a weak link in trials, says O’Shaughnessy

pharmaphorum

Primary care a weak link in trials, says O’Shaughnessy Phil.

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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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How the Industry Can Enable a Realistic Adoption to DSCSA Compliance 

National Association of Boards of Pharmacy

As the DSCSA interoperability deadline approaches, we at NABP remain focused on critical Drug Supply Chain Security Act (DSCSA) infrastructure and committed to helping align all sectors of the supply chain that support and provide safe medication to patients in the United States. This is the third blog of a series that explores steps we must take before the November DSCSA deadline.

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Overcoming bottlenecks in the advanced therapy supply chain

European Pharmaceutical Review

In recent years, the pharmaceutical industry has had to grapple with the scalability of advanced therapies. Yet as the traditional issue of production capacity eases, what has been given far too little attention, so far, is whether the required digital and supply chain management infrastructure is in place. The personalised nature of each treatment means every application comes with an unusually high administrative burden, making the wider adoption simply unworkable in many clinical settings.

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Adverse reactions biobank to launch next month

The Pharmacist

A genetic ‘biobank’ will be launched on 1 June 2023 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to understand how a patient’s genetic make up can impact the safety of their medicines. Known as the Yellow Card biobank, the biobank will contain genetic data and patient samples and be used by scientists […] The post Adverse reactions biobank to launch next month appeared first on The Pharmacist.

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Health Innovators – Jennifer Schranz

pharmaphorum

Health Innovators – Jennifer Schranz Mike.

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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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New palliative care standards provide ‘roadmap’ for pharmacies

The Pharmacist

Community pharmacies across the UK can now sign up to new quality improvement standards for palliative and end of life care. The Daffodil Standards, born from a partnership between the Royal Pharmaceutical Society (RPS) and charity Marie Curie, set out areas of good practice and hope to help improve the care provided to patients approaching […] The post New palliative care standards provide ‘roadmap’ for pharmacies appeared first on The Pharmacist.

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Pharmanovia pledges commitment to SBTI net zero target

Express Pharma

Pharmanovia, a company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has announced increased targets to divert 40 per cent of its air shipments to sea in 2023, and 75 per cent by the end of 2028. Pharmanovia revealed the significant progress made towards achieving its ESG initiatives in its new Sustainability Report.

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Large study provides scientists with deeper insight into long COVID symptoms

World Pharma News

Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19.

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UK families lose bid for compensation over Primodos pregnancy test drug

The Guardian - Pharmaceutical Industry

High court rules there is insufficient new evidence of causal link between hormone-based test and birth defects An attempt by more than 100 UK families to seek compensation for birth defects they say were caused by the hormone-based pregnancy test Primodos has been struck out by the high court. The families, who believe their babies suffered a range of congenital abnormalities due to the drug, were hoping to rekindle a civil case against the manufacturer after a previous attempt collapsed in 198

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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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Acquisition and Investment Spur AVEO Oncology to New Heights

PharmExec

Ahead of ASCO and BIO, Michael Bailey CEO of AVEO Oncology, discusses the company becoming a LG Chem subsidiary and the future for drug development in the combined entity.

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Beta Bionics’ automated insulin delivery system picks up manufacturing partner

Pharmaceutical Technology

Chronic disease tech company Convatec Group has partnered with Beta Bionics to manufacture the insulin delivery system iLet Bionic Pancrease. According to Beta Bionics, this is the only first and only automated insulin delivery system that carries 100% of doses and does not require carb counting. The device received US Food and Drug Administration 510(k) clearance last week for those ages six years and above living with type 1 diabetes.

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Five Trends Transforming Pharmacies into Wellness Centers of the Future

Pharmacy Times

With so many radical developments in medicine and technology unfolding at once, the role and potential of the pharmacy as we know it is evolving at breakneck speed.

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