Fri.Sep 06, 2024

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Missouri resident who had no contact with animals tests positive for bird flu

STAT

This is a developing story and will be updated. A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.

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What 3 layoff stories reveal about pharma’s troubles

PharmaVoice

The factors driving the industry’s layoffs — and what could help turn the tide.

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Opinion: Presidential debate moderators should ask about mental health policy

STAT

As the mom of three young adults, I am worried about their economic future — their ability to get jobs and afford homes. But I am equally concerned about their mental health and well-being. A 2022 national survey found that approximately half of young people ages 18-25 have a mental illness, substance use disorder, or both. Suicide and overdose rates remain persistently high: As Nicholas Kristof has written, “every three or four days we lose as many Americans to drugs, alcohol and

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Immuneel Therapeutics welcomes Amit Mookim as CEO

Express Pharma

Immuneel Therapeutics a cell and gene therapy platform, announced the appointment of Amit Mookim as its new Chief Executive Officer. He brings over two decades of experience across life sciences, technology and private equity, making him ideally suited to lead Immuneel into its next phase of growth and innovation. Mookim joins Immuneel from IQVIA, a Fortune 500 in clinical research, technology and analytics, where he served as Managing Director for South Asia.

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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+: Ascension, other hospitals played active roles to take medical billing company R1 RCM private

STAT

Private equity firms are leading the buyout of R1 RCM , a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome. Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners.

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Moderna’s updated Covid-19 vaccine receives positive EMA CHMP opinion

Pharmaceutical Business Review

This recommendation will aid in the potential authorisation of the vaccine for use in individuals aged six months and older to prevent Covid-19 in the upcoming 2024-2025 autumn/winter season. The CHMP’s positive opinion is grounded in a comprehensive evaluation, including manufacturing and preclinical data, as well as earlier clinical, non-clinical, and real-world evidence confirming the vaccine’s efficacy and safety.

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GSK says Nucala hits the target in new COPD trial

pharmaphorum

GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.

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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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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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STAT+: Pharmalittle: We’re reading about FDA inspections, Lilly insulin trial results, and more

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 shaping up. As always, we plan to promenade with the official mascots and catch up on our reading, although we also expect to entertain a traveler. On that note, we are planning another listening party, where the rotation will likely include this , this , this , this , and this.

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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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Strides gains USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg

Express Pharma

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food and Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR, of Schering Corp.

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STAT+: Dana-Farber’s Laurie Glimcher is leaving on her own terms. That’s the difference between male and female leadership.

STAT

Laurie Glimcher stunned Boston’s medical world  last September  by orchestrating Dana-Farber Cancer Institute’s breakup with its longtime partner, Brigham & Women’s, so her institution could build its own free-standing hospital. Now Glimcher has made another bold pronouncement: On Oct. 1, she will step down as Dana-Farber’s CEO, and let someone else implement her vision.

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Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head

Express Pharma

Akums Drugs and Pharmaceuticals has announced the appointment of Shantanu R Chobhe as the Corporate Quality Assurance Head. At Akums, Chobhe will take charge of all quality assurance (QA) and quality control (QC) departments, overseeing both active pharmaceutical ingredients (API) and formulations. His deep expertise in quality management and regulatory affairs will be critical as Akums continues to uphold its commitment to delivering high-quality pharmaceutical products.

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BioAge's $100m IPO, and other biotech financings

pharmaphorum

Financings in the biotech sector this week include an IPO filing for BioAge and private rounds for eGenesis, Navigator, and Circle Pharma.

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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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Sun Pharma and Moebius Medical gain fast track designation for MM-II for the treatment of Osteoarthritis Knee Pain

Express Pharma

Sun Pharmaceutical Industries (and its subsidiaries or associate companies) and Israel-based Moebius Medical announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MM- II is underway.

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Lykos CEO steps down after MDMA is rejected by FDA

pharmaphorum

The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.

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Funding shortfall leaves pharmacies ‘stuck in a hole’, IPA tells MPs

The Pharmacist

An ongoing funding shortfall has left pharmacies in a ‘hole’ they are struggling to get out of, parliamentarians have been told as part of an event hosted by the Independent Pharmacies Association (IPA). MPs and peers were also warned that Pharmacy First thresholds are 'unrealistic', while concerns were raised about the scheme's reliance on GP […] The post Funding shortfall leaves pharmacies ‘stuck in a hole’, IPA tells MPs appeared first on The Pharmacist.

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Eli Lilly’s once-weekly insulin shows promise in phase 3 trials

Pharma Times

New treatment could simplify diabetes management for millions

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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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MHRA warns men taking valproate to use contraception over small risk to children

The Pharmacist

The UK medicines regulator has warned that men taking valproate and their partners should use effective contraception, because of a small increased risk of harm to children if the drug is used by a father at conception. Healthcare professionals should inform male patients about this ‘newly identified risk’ at their next routine treatment review and […] The post MHRA warns men taking valproate to use contraception over small risk to children appeared first on The Pharmacist.

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EMCrit 383 – The Ultrasound Hierarchy of Needs in Cardiac Arrest with Mike Prats

EMCrit Project

Learn about how to use ultrasound during cardiac arrest EMCrit Project by Scott Weingart, MD FCCM.

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FDA approves Amneal and Shilpa’s oncology product BORUZU

Pharmaceutical Technology

The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.

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Embracing diversity in psychiatry and neurology clinical trials

pharmaphorum

Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.

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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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NHSE publishes guidance for community pharmacies dealing with suspected mpox

The Pharmacist

NHS England (NHSE) has published a pathway for community pharmacies to follow if a patients presents with suspected mpox. If a clinical assessment is required to determine if the patient is a possible or probable case, they should be assessed remotely – for instance, on the phone, NHSE said. And staff should not physically assess […] The post NHSE publishes guidance for community pharmacies dealing with suspected mpox appeared first on The Pharmacist.

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Lilly adds to genetic meds push with Genetic Leap alliance

pharmaphorum

Eli Lilly signs another genetic medicines deal, this time with Genetic Leap, a start-up that applies AI to the discovery of RNA-targeted drugs.

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Embracing cannabis in ayurvedic products: A progressive step forward?

Express Pharma

Introduction to Cannabis Medicinal cannabis is increasingly recognised for its potential to alleviate symptoms of a variety of medical conditions, such as chronic pain and anxiety, providing an alternative to traditional pharmaceuticals. Ayurveda, for example, has more than 260 formulations based on the cannabis plant. In India, the production, possession, sale, and consumption of cannabis is prohibited except for medical, industrial, or scientific purposes under the Narcotic Drugs and Psychotr

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Balancing innovation and safety: The impact of Medtech regulations

pharmaphorum

Understanding the impact of Medtech regulations on balancing innovation and safety is crucial for the industry. Discover how compliance with regulations plays a vital role in fostering innovation while ensuring patient safety in the field of medical technology.

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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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Obesity drug startup raises $67M; Vor’s ‘shielded transplant’ shows promise

BioPharma Dive

OrsoBio is advancing several weight loss medicines. Elsewhere, Boehringer Ingelheim pushed forward with a geographic atrophy drug and Vaxcyte raised $1.3 billion.

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A new AI tool for cancer

World Pharma News

Scientists at Harvard Medical School have designed a versatile, ChatGPT-like AI model capable of performing an array of diagnostic tasks across multiple forms of cancers. The new AI system, described Sept. 4 in Nature, goes a step beyond many current AI approaches to cancer diagnosis, the researchers said. Current AI systems are typically trained to perform specific tasks - such as detecting cancer presence or predicting a tumor's genetic profile - and they tend to work only in a handful of canc

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GSK antibody drug reduces COPD attacks in trial

BioPharma Dive

New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.

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Data Integrity in the Pharmaceutical & Life Sciences Industry

Viseven

Data is everywhere. No matter how big your company is or what its main services or products are, it’s likely that it relies on data for daily operations. Good record management practices, quality risk management, and robust compliance frameworks are standard procedures in industries like pharmaceuticals and life sciences. All of it is done to assure data integrity—the glue that holds together all measures and actions performed to keep the data safe, error-free, and complete.

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What’s in it for me? Branded ingredients driving rise of Indian dietary supplements

Express Pharma

Health-conscious Indian consumers are increasingly turning towards branded ingredients as an effective solution in today’s fast-paced world. What do branded ingredients provide that is special, making them preferred over generic ingredients? Branded ingredients are proprietary or patented formulations developed and marketed under a specific brand name by manufacturers.