Wed.Sep 18, 2024

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Opinion: Tested in Africa, used in America

STAT

At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.

Vaccines 363
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Getting IND ready — how companies can avoid common traps

PharmaVoice

Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.

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Trending Sources

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Year-long fallout over retracted trans youth paper highlights new research era

STAT

Last year, a Springer Nature journal published a study surveying 1,700 parents of adolescents and young adults with gender dysphoria. Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study. But the story didn’t end there. Ongoing fallout from the paper and its retraction has opened up an internal rift among academic editors and journal staff that led to one editor’s resignation, as first reported by Retrac

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FDA inspection backlog overseas threatens new drug approvals

PharmaVoice

The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.

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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+: Hospital giant Ascension recorded about $1.3 billion in losses from its cyberattack

STAT

The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 billion, according to STAT’s analysis of financial documents the health system released Tuesday evening.

Hospitals 356
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Vizient announces 2024 top performers in clinical quality, supplier diversity and environmental sustainability excellence

vizient

The awards recognize the achievements of participating hospitals and health systems in patient care quality and supply chain excellence and were announced Sept. 17 in Las Vegas.

Hospitals 140

More Trending

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GPhC proposes stricter guidance for online pharmacies and weight loss meds

The Pharmacist

The General Pharmaceutical Council (GPhC) has proposed new guidance to safeguard against the risks of online prescribing, including of weight loss medication. This follows 'significant risks to patient safety when online questionnaires have inappropriately been the only mode of consultation used', which the GPhC said it had observed through its inspections and investigations.

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STAT+: In race to make gene therapy for age-related blindness, 4D Molecular announces positive results

STAT

A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up. On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks.

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Pfizer sets up Analytics Gateway capability centre in India

Express Pharma

Pfizer has launched the company’s first dedicated commercial analytics centre in India called, ‘the Analytics Gateway’. The centre comprises a talented and experienced pool of data and analytics experts. The Analytics Gateway set up in Mumbai, is expected to accelerate data science and AI solutions to meet Pfizer’s ambitions in modernising marketing and creating an agile sales force.

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STAT+: House panel passes pediatric rare disease bill, setting it up for government funding bill

STAT

A House committee on Wednesday passed a bill to renew a program aimed at aiding development of drugs for rare diseases in children , putting it in a better position to be added to government funding legislation.  The pediatric rare disease priority review voucher program is set to end on Sept. 30. The legislation would extend the program until Sept. 30, 2029.

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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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PBM strikes back at FTC over drug pricing report

pharmaphorum

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

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Opinion: The U.S. should follow California’s lead on banning toxic chemicals in IV bags and tubes

STAT

In 2017, at the age of 42, Susan Whitehead was diagnosed with an early form of breast cancer after discovering a lump in her breast. She embarked on a challenging path of treatment, including a recurrence with stage 2 cancer four years later. Susan underwent two lumpectomies, a mastectomy, radiation, and chemotherapy. Throughout this process, she was steadfast in her resolve to seek the best possible care, which included demanding a controversial full-body scan that led to an unexpected discover

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NHS Trust to evaluate AI software for prostate cancer diagnosis

Pharma Times

It is hoped that the tool will improve the diagnostic pathway and free up radiologists’ time

Hospitals 131
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STAT+: Social media diss highlights high-stakes rivalry over colon cancer blood tests

STAT

Biotech companies routinely compete to develop and commercialize products. But these rivalries are seldom as publicly heated as what has played out on social media this week between two firms racing to develop new ways to screen for colon cancer. Over the weekend, during the leadup to Exact Sciences announcing data from a blood-based colon cancer test, Guardant Health co-CEO AmirAli Talasaz challenged Exact’s CEO, Kevin Conroy, in a LinkedIn post that was unusually confrontational.

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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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Solution Spotlight: Aktiia Blood Pressure Technology

pharmaphorum

In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.

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Bernie Sanders keeps the heat on Novo’s high prices

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. My colleague Ed Silverman, who I view as the foremost expert on drug patents (and coffee flavors), has been taking a closer look at patent claims to bring us an exclusive analysis. We get into all of that today.

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Radiopharmaceuticals for prostate cancer to go nuclear with $6.3 bn in sales by 2030

Express Pharma

Radioligand therapies (RLTs) have received prominent attention from major pharmaceutical companies in treating prostate cancer. Bayer’s Xofigo (radium-223 dichloride) demonstrated the proof-of-concept with its FDA approval for castration-resistant prostate cancer (CRPC). Interest in RLTs has since peaked, with Novartis acquiring developer Advanced Accelerator Applications and the highly effective Pluvicto (lutetium [177Lu] vipivotide tetraxetan), targeting prostate-specific membrane antigen (PSM

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STAT+: Roivant strikes another deal, selling dermatology spinoff to Organon in deal worth $1.2 billion

STAT

Roivant Sciences continues its dealmaking hot streak, announcing Wednesday that it would sell one of its subsidiaries to pharma company Organon in a deal worth $1.2 billion. Organon is buying Roivant subsidiary Dermavant and its topical treatment Vtama. The drug is currently approved to treat various forms of the skin condition plaque psoriasis. But analysts and Organon see the real potential in Dermavant’s standing application with the Food and Drug Administration to expand the drug

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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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Lupin partners with Takeda to commercialise Vonoprazan

Express Pharma

Lupin announced that it has entered into a non-exclusive patent license agreement with Takeda Pharmaceutical Company, to commercialise Vonoprazan Tablets in the Indian market. The drug will be marketed under the brand name Lupin’s Lupivon and will be available in two strengths – 10 mg and 20 mg. Under the terms of this agreement, Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India.

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STAT+: House panel advances bill to extend Medicare’s telehealth flexibilities, setting up December talks

STAT

A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives. Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth.

Hospitals 294
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Lilly on alert as new Kisqali approval threatens Verzenio

pharmaphorum

Novartis' Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over rival Verzenio from Eli Lilly

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STAT+: Pharmalittle: We’re reading about pharma patent maneuvers, the U.S. warning J&J, and more

STAT

Hello, everyone, and how are you today? We are muddling along, but the middle of the week is upon us, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So we are digging about the pantry and firing up our coffee kettle to get things started.

Hospitals 266
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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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The high cost of inequality: High US healthcare spend falls short

pharmaphorum

Explore the high cost of inequality in the US healthcare system and why despite the significant spending, it falls short in delivering adequate services and outcomes. Gain insights into the challenges and potential solutions.

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FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis

World Pharma News

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people livi

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FDA expands Novartis’ Kisqali label to include early breast cancer patients

Pharmaceutical Technology

Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.

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Cutting Costs with a CDMO: Strategies for Success in Biopharmaceutical Manufacturing

Drug Patent Watch

The biopharmaceutical industry is constantly evolving, with the demand for complex biologics on the rise. To stay competitive, companies must navigate the complexities of biopharmaceutical development while managing costs effectively. One key strategy for achieving this balance is partnering with Contract Development and Manufacturing Organizations (CDMOs).

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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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MHLW accepts GSK’s multiple myeloma treatment NDA for review

Pharmaceutical Technology

Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.

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All parts of Pharmacy First should be open to walk-ins, says CPE

The Pharmacist

The treatment of minor illnesses and the urgent supply of medicines under the Pharmacy First service should be made accessible to walk-in patients, Community Pharmacy England (CPE) has told The Pharmacist. The negotiator's ask, which it is using in its influencing and public affairs work, comes as The Pharmacist's recent roundtable with community pharmacy and […] The post All parts of Pharmacy First should be open to walk-ins, says CPE appeared first on The Pharmacist.

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FlyPharma Europe, Vienna – October 2024 conference

Pharma Times

The conference will return to Vienna AirportCity on 23 to 24 October 2024

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BREAKING: NPA to ballot pharmacists on working to rule

The Pharmacist

BREAKING The National Pharmacy Association (NPA) is balloting its members on working to rule amid growing concerns over funding and budget cuts, it has announced today. If passed, thousands of pharmacies across England, Wales and Northern Ireland could take collective action before Christmas, in an unprecedented move for the sector. The ballot, which will be […] The post BREAKING: NPA to ballot pharmacists on working to rule appeared first on The Pharmacist.

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Women in science - Alison O'Neill at YPrime on thinking out loud and collaborating

Outsourcing Pharma

Alison has more than 35 years of broad experience delivering clinical trials to sponsors with a patient centric mindset.

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