Sat.Aug 31, 2024 - 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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FDA adcomm reform talks heat up

PharmaVoice

As the agency considers eliminating adcomm votes from the approval process, members vie to have their voices heard.

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A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

BioPharma Dive

Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

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The Life Sciences Generative AI Council and a sustainable technological future

pharmaphorum

Listen to the podcast interview with Manny Belabe from ArisGlobal as he discusses The Life Sciences Generative AI Council and its role in creating a sustainable technological future. Gain insights into the future of AI in life sciences.

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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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In a first, living mice are made transparent

STAT

When a dye called tartrazine is added to food, it creates a bright yellow hue often associated with lemon-flavored candy. But when mixed with a little water and daubed on the skin of mice, the dye makes their skin nearly transparent.  Researchers reported the new use for the common food dye today in the journal Science. The technique creates a fresh opportunity for researchers to understand what is going on under the skin of a live animal, which could eventually allow them to study the inne

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Pharma’s ‘it’ therapy — a new drug class gaining steam

PharmaVoice

More companies are investing in protein degraders, which leverage a unique approach to harnessing the immune system in cancer, neurological diseases and more.

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China detains AstraZeneca workers in data, imports probe

pharmaphorum

A "small number" of AstraZeneca employees have been detained in China in an investigation into suspected data privacy and drug import breaches

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Doctors use problematic race-based algorithms to guide care every day. Why are they so hard to change?

STAT

Pediatrician Alexandra Epee-Bounya had had enough. In her 20 years caring for children in Boston, she had seen hundreds of kids with suspected urinary tract infections. Each time, she’d turn to a calculator, used by all Boston Children’s Hospital clinicians, to judge the youngest childrens’ risk. Did the infant have a high fever?

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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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ArsenalBio raises $325M in one of the year’s largest biotech funding rounds

BioPharma Dive

The funding comes amid a slowdown in venture investment for gene and cell therapy startups, and will support development of multiple solid tumor programs.

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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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Pharmacy contract negotiations expected to resume 'soon'

The Pharmacist

Negotiations on the delayed community pharmacy contract in England are expected to resume 'soon', Community Pharmacy England (CPE) has said following a meeting with the pharmacy minister. CPE chief executive Janet Morrison, along with two community pharmacy members of the CPE negotiating team, has met with care minister Stephen Kinnock, the negotiator said.

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Trying to time your seasonal vaccines just right? There are no easy answers, but here are some factors to consider

STAT

With fall coming into view, public health officials across the country are turning to the annual task of persuading legions of Americans to get vaccinated against some combination of influenza, Covid-19, and respiratory syncytial virus, three bugs that sicken mass numbers of people over the winter months, often overwhelming hospitals and health care delivery in the process.

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First-in-class combination therapy authorised for endometriosis

European Pharmaceutical Review

The Medicines and Healthcare Products Regulatory Agency (MHRA) has licenced the first treatment (oral gonadotropin-releasing hormone [GnRH] receptor antagonist) in a new class of medicines for women in the UK with endometriosis. Relugolix combination therapy, Ryeqo (relugolix 40mg, estradiol 1mg, and norethisterone acetate 0.5mg), is authorised to treat endometriosis symptoms in adults.

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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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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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NPA warns of 'pharmacy deserts' in rural and deprived areas

The Pharmacist

Disproportionately low pharmacy provision and over-reliance on one pharmacy group could put rural areas at risk of becoming a 'pharmacy desert', the National Pharmacy Association (NPA) has warned. And above-average levels of closures in deprived areas risk widening health inequalities, the association added. In new analysis published today, the NPA found that 87% of local […] The post NPA warns of 'pharmacy deserts' in rural and deprived areas appeared first on The Pharmacist.

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Opinion: Letting funding for the All of Us research program lapse will cost the U.S. far more than it saves

STAT

I was in high school when I first encountered the ruthlessness of the number one killer in the U.S. A close friend of mine, then only 16 years old, witnessed his father having a heart attack while checking the mail. Despite desperate attempts at CPR on the driveway, he wasn’t able to save his dad, a seemingly healthy man in his early 40s. That event put me on a path to become a cardiologist.

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HDA 2024 Traceability Seminar: Best Practices Amid the Forthcoming Stabilization Period

Pharmaceutical Commerce

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

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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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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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High-dose psilocybin may be effective in treating depression

The Pharmacist

High doses of psilocybin – the psychedelic ingredient in magic mushrooms – appear to have a similar effect on depressive symptoms as an antidepressant, according to a meta-analysis of the evidence. But some of the promise of psychedelic treatment for depression may have been overestimated due to issues with trial design, the results suggest. The […] The post High-dose psilocybin may be effective in treating depression appeared first on The Pharmacist.

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STAT+: Diagnosed with cancer, a pharmaceutical executive became a patient advocate and changed drug development. It took decades

STAT

Kathy Giusti was diagnosed with multiple myeloma in 1996, when she was a 37-year-old executive at the drug company G.D. Searle. She was told she had three years to live. Twenty-eight years later, Giusti, 65, is thriving. One reason is the patient advocacy group she founded in 1998: the Multiple Myeloma Research Foundation. The group has raised more than $600 million for research, launched nearly 100 clinical trials, and helped bring more than 15 new drugs to market.

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HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

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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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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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NHSE issues advice to pharmacies ahead of early release of prisoners

The Pharmacist

NHS England (NHSE) has issued advice on the role of community pharmacies in supporting individuals who will be released early from prison in the coming weeks. A letter from NHSE has flagged the potential for Pharmacy First and the Pharmacy Contraception Service to be used to support those being let out of prison as part […] The post NHSE issues advice to pharmacies ahead of early release of prisoners appeared first on The Pharmacist.

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Moderna reports encouraging results on its mpox vaccine, as outbreaks in Africa spread

STAT

The emergence of a second mpox outbreak in which the virus is spreading from person-to-person, as well as a sharp increase in overall cases of the disease in several African countries, is straining the world’s capacity to make and distribute vaccine to battle the threat. New options are needed, and a study published Wednesday suggests another may be on the horizon.

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Weight-loss drugs ‘slow down the ageing process’, scientists suggest

The Guardian - Pharmaceutical Industry

Semaglutide – contained in Ozempic and Wegovy – has ‘far-reaching benefits’, with people dying at lower rate from all causes Weight-loss drugs are poised to revolutionise healthcare by slowing down the ageing process and by allowing people to live for longer and in better health. That is the dramatic message from leading scientists after studies were presented last week at the European Society of Cardiology Conference in London.

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Zydus receives USFDA warning letter for Jarod facility

Express Pharma

Zydus Lifesciences has received a Warning Letter issued by the US Food and Drug Administration for its Injectables manufacturing facility at Jarod near Vadodara, Gujarat. The Warning Letter summarises violations concerning Current Good Manufacturing Practice (cGMP) regulations. The letter does not contain any data integrity-related violations. Earlier, on July 18, the facility received an OAI status.

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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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Primary care staff need more support to manage rise in food allergies, say researchers

The Pharmacist

Primary care staff need urgent support and training to care for people with food allergies, according to researchers who found that numbers have doubled since 2008. An analysis published in The Lancet Public Health said the largest rise had been seen in young children but the reasons behind the trend were not clear. In a study of […] The post Primary care staff need more support to manage rise in food allergies, say researchers appeared first on The Pharmacist.

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Upending a longstanding paradigm, cardiologists embrace ZIP codes, not race, to predict heart risk

STAT

N ot only is Joseph Wright a physician, he’s the chief health equity officer for the American Academy of Pediatrics. So he was skeptical when, at his annual checkup in January, an alert popped up on his doctor’s computer screen. A calculator embedded in Wright’s health record had automatically pulled in his data, including the blood test he had done that morning.

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Lilly builds case for weekly insulin shot

BioPharma Dive

New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.

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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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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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