Sat.Jan 13, 2024 - Fri.Jan 19, 2024

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How to make 2024 a banner year for biopharma, despite the headwinds

PharmaVoice

Creative thinking is the name of the game as biopharmas seek to overcome a host of challenges — and investing with purpose, building trust and embracing tech could get them there.

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STAT+: Dana-Farber cancer researchers moving to retract one paper, correct others in broad investigation of manipulated data

STAT

Scientists at Dana-Farber Cancer Institute, one of the nation’s leading cancer research and treatment centers, are “moving to” retract one paper and correct others amid an expanding investigation of data manipulation, officials told STAT. The investigation includes scores of papers authored by four top scientists and institute leaders, including CEO Laurie Glimcher and COO William Hahn.

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Navigating A Unique Journey: Dr. Lindsey Moseley’s Inspiring Path in Pharmacy Education

Pharmacy Is Right For Me

A pharmacy education provides diverse opportunities, ranging from patient care and research to education. Truly, no one path looks the same and there is no better example than Dr. Lindsey Moseley who found her passion for teaching and education whilst pursuing her Pharm.D. degree. Facing An Identity Crisis Dr. Lindsey Moseley is the Curricular Coordinator and a faculty member at Auburn University Harrison College of Pharmacy.

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CellVoyant secures £7.6 million AI stem cell boost

Pharma Times

CellVoyant’s platform combines AI with live cell imaging

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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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Pharma takes a gut check of microbiome drugs

PharmaVoice

On the heels of two FDA approvals for microbiome-based therapies, interest in the space is gaining steam.

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STAT+: The FDA’s diagnostics chief, who led through Covid, has retired

STAT

Timothy Stenzel, the federal regulator who led the Food and Drug Administration’s diagnostics division during the chaotic time of Covid-19 pandemic, has left the agency. The FDA confirmed Thursday that Stenzel, who led the FDA’s office of in vitro diagnostics, retired at the end of 2023.  During the early days of the pandemic, Stenzel was in the middle of a turf battle between the Centers for Disease Control and Prevention and the FDA over the regulation of Covid tests.

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More Trending

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Stroke experts to test emerging nerve stimulation treatment

Pharma Times

New stroke therapy delivers electrical pulses to the brain

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FDA chief says agency can’t manage health tech alone

PharmaVoice

FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.

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Could long Covid’s signs of immune dysregulation in the blood lead to a diagnostic test?

STAT

Long Covid has long eluded scientists looking for its cause. Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. New research published Thursday in Science has identified proteins present in the blood of people with long Covid that could point the way to a much-needed diagnostic test and possibly to future therapeutic targets.

Immunity 363
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‘The worst I’ve known it’: the struggle to get vital medicines in the UK

The Guardian - Pharmaceutical Industry

Four people with conditions that require consistent medication explain how the shortages have affected their wellbeing NHS medicines shortage putting people at risk, pharmacists warn Analysis: why is UK being hit by medicine supply shortages? More people in the UK are struggling to access vital medicines than ever before, exacerbating conditions from epilepsy to the menopause.

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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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StemSight and ERS Genomics focus on collaboration

Pharma Times

License agreement concerns development of cell therapies for corneal blindness

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Women’s health gap estimated at $1trn in new report

pharmaphorum

The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.

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Pumping breastmilk in bathrooms is a common, albeit unspoken, practice at health care conferences

STAT

Even though Erin Booth was not thrilled about having to travel to Philadelphia for a conference at six weeks postpartum, this one at least advertised having a private lactation space. This was back in 2013, when such accommodations were a rarity. The first bad sign was having to walk clear across the convention center to get there, cutting into her already brief pumping window.

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Call for PCNs to deploy pharmacists across multiple settings

The Pharmacist

Pharmacists employed by primary care networks (PCNs) should be deployed to work ‘where they are needed’ and across multiple settings, including in community pharmacies, the chair of the Pharmacists’ Defence Association (PDA) has suggested. Giving evidence to the Health and Social Care Committee (HSCC)’s pharmacy inquiry yesterday, Mark Koziol proposed using Additional Roles Reimbursement Scheme […] The post Call for PCNs to deploy pharmacists across multiple settings appeared first on The

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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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Synendos receives EMA nod for brain therapy

Pharma Times

Company is focused on endocannabinoid system treatments

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FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

LifeProNow

January 08, 2024: “The U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

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The WHO and drug regulators want to reformulate the flu vaccine. It’s easier said than done

STAT

Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic. It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie.

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MHRA urges caution for men taking valproate

The Pharmacist

Male patients taking valproate have been urged to speak to their healthcare professional if they are planning to have children in the next year. This comes as the UK medicines regulator considers new evidence suggesting that children whose fathers took valproate are at increased risk of neurodevelopmental disorders. A new study, commissioned by the European […] The post MHRA urges caution for men taking valproate 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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Poolbeg’s cytokine release syndrome candidate shows potential

Pharma Times

Data supports Poolbeg’s strategic expansion of POLB 001

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Five years after closing the Shire deal, Takeda is ready to harvest from its latest reinvention

PharmaVoice

Amid criticisms of Takeda’s megamerger, the company’s CSO said it has built a pipeline that will deliver.

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Feds bar Theranos founder Elizabeth Holmes from government health programs

STAT

WASHINGTON — Theranos founder and ex-CEO Elizabeth Holmes is banned from federal health programs for nine decades, the health department announced Friday. Holmes was sentenced in November 2022 to 11 years in prison following a trial that determined she knew her blood-testing startup, which was founded in 2003 and which claimed to be able to test for a range of diseases and risks with one finger prick, produced inaccurate and faulty results.

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Tr1x, a new biotech, joins ‘Treg’ chase with $75M fundraise

BioPharma Dive

The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.

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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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UCB announces MHRA approval for UCB’s Zilbrysq

Pharma Times

Green light concerns generalised myasthenia gravis therapy

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Around 3,000 pharmacies sign up to contraception service

The Pharmacist

Around 3,000 pharmacies in England have now signed up to provide the NHS Pharmacy Contraception Service, the government has confirmed. This comes as health secretary Victoria Atkins said that problem periods, menopause and maternity care would be top priorities under the government’s women’s health strategy in 2024. And it follows the expansion of the Pharmacy […] The post Around 3,000 pharmacies sign up to contraception service appeared first on The Pharmacist.

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STAT+: FDA expands approval of CRISPR-based medicine to treat beta thalassemia

STAT

The Food and Drug Administration on Tuesday approved a CRISPR-based medicine to treat beta thalassemia, an inherited blood disorder. It’s the same potentially curative therapy cleared by the FDA in December to treat sickle cell disease. The expanded approval of the therapy, called Casgevy, was widely expected but came two months ahead of the FDA’s decision deadline, known as a PDUFA date.

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Kyverna sets plans for IPO in test of biotech market

BioPharma Dive

The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.

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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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Serac to present data from DETECT study

Pharma Times

Company will present vital findings at SRI annual meeting

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Patients could be hesitant about Pharmacy First, warns Healthwatch England

The Pharmacist

Patient hesitancy and concerns about privacy could mean a slow uptake of Pharmacy First services, the head of policy, public affairs and research at Healthwatch England has warned. Speaking to the Health and Social Care Committee (HSCC)’s pharmacy inquiry this week, William Pett suggested that greater public awareness of pharmacy services was needed for patients […] The post Patients could be hesitant about Pharmacy First, warns Healthwatch England appeared first on The Pharmacist.

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Bernie Sanders proposes subpoenas of CEOs of J&J, Merck on drug prices

STAT

WASHINGTON — Senate health committee chair Bernie Sanders has taken a step toward subpoenaing the CEOs of Johnson & Johnson and Merck related to an investigation into high drug prices in the United States, he announced Thursday. The step is highly unusual, as the health committee hasn’t issued a subpoena in more than 40 years.

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FDA widens approval of Vertex’s CRISPR medicine to treat beta thalassemia

BioPharma Dive

The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.

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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.