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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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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From Payroll Pains to Growth Gains: Streamlining Payroll & HR for Success

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

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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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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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More Trending

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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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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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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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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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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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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+: 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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.

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Corporate Trainer Becky Clark: Welcome To The “Pharmily”

Proxsys Rx

Week One: Tallahassee, Florida. Training at the pharmacy. Week Two: Holyoke, Massachusetts. Training at the pharmacy. Week Three: Houma, Louisiana. Training at the pharmacy. Week Four: Home. You’d think, at some point, that a life spent mostly on the road — living out of a suitcase, repeating the same processes week-in and week-out — might become something of a dull, dispiriting grind for this grandmother of two.

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Gene therapy trial facilitates major vision improvement

European Pharmaceutical Review

Results from a Phase I/II gene therapy trial have demonstrated that ATSN-101 enabled patients with a rare inherited disease to gain substantial, rapid improvement in their vision. Participants with Leber congenital amaurosis (LCA1) due to mutations in the GUCY2D gene were evaluated in the one-year clinical trial. Of the 15 participants, three were paediatric subjects.

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Nucala Significantly Reduces Moderate to Severe Exasperations in Chronic Obstructive Pulmonary Disease

PharmExec

Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.

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Surge in pharma funding observed in August 2024, reached $135 mn

Express Pharma

Funding in the pharma and healthcare space surged 382 per cent to $135 million in August 2024, from $28 million in July 2024. This is also a growth of 20 per cent from the $112 million raised in August 2023. Most of the funding (62.2 per cent) in August 2024 came from late-stage investments. Followed by early-stage and seed-stage rounds, which accounted for 31.5 per cent and 6.3 per cent of the total funding.

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