Thu.Jul 18, 2024

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Opinion: IRBs fail to assess trials’ scientific merit, putting participants at risk

STAT

Thousands of people volunteer for clinical research trials in the United States every year. They put their bodies on the line, often seeking benefits from experimental treatments because existing care is ineffective. For most clinical trials, independent institutional review boards (IRBs) are legally required to review the protocol before enrollment can begin.

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Gilead eyes ‘ending the HIV epidemic’ via incremental progress

PharmaVoice

With a long elusive HIV cure ever on the horizon, Gilead’s latest long-acting PrEP study shows that every step counts.

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Trending Sources

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STAT+: Broad Institute, facing end of Microsoft cloud contract, shuffles data science leadership

STAT

The Broad Institute of MIT and Harvard is perhaps best known for the trailblazing work coming out of the labs of its core members; CRISPR tools like David Liu’s prime and base editors , Feng Zhang’s virus-like drug delivery particles , or Pardis Sabeti’s network of low-cost diagnostics designed to catch the next pandemic before it starts.

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Cystic fibrosis drug improves outcomes in severe COVID-19 pneumonia

Pharma Times

Genentech’s Pulmozyme could also treat other respiratory infections and conditions

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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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‘Legal’ psychedelic mushrooms actually contain illegal hallucinogens, study shows

STAT

WASHINGTON – A new study published Thursday finds that several mushroom candies, which are widely promoted as containing legal psychedelic ingredients, actually contain illegal hallucinogens. The study sampled products sold in gas stations and smoke shops near Charlottesville, Va. It identified the Schedule I drug psilocin in mushroom candies sold under the brand names Diamond Shruumz and Wonderland Legal Psychedelics.

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Massive study of veterans’ DNA shows how diversity can help researchers decipher the genome

STAT

An expansive new study offers clear evidence that sequencing the genomes of diverse populations can yield fresh insights into how our DNA shapes our health. A team of researchers involved in an ongoing project spearheaded by the U.S. Department of Veterans Affairs analyzed data from nearly 636,000 veterans to look for genetic variants associated with more than 2,000 traits, such as height, blood glucose levels, and whether subjects had certain cancers.

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Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

BioPharma Dive

The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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STAT+: Startup Q Bio raises $27 million to build its own full-body scanner

STAT

A prevention-focused co-founded by the head of a Stanford research lab is making an expensive bet with its latest fundraise: that it can build a better full-body scanner than medical device behemoths selling MRIs to health systems. Palo Alto-based Q Bio raised $27 million in “strategic funding” from existing investors including Khosla Ventures, Andreessen Horowitz, and Founders Fund, the company shared with STAT exclusively.

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PDA accuses regulator of inaction and incompetence on training standards

The Pharmacist

A major pharmacists’ union has suggested that the pharmacy regulator has failed to take action on addressing potential racial bias and disparities in educational attainment. And it raised concerns about pharmacy technician training. In particular, it highlighted one provider that had 'softened' its science entry requirement. The Pharmacists’ Defence Association (PDA) was responding to the […] The post PDA accuses regulator of inaction and incompetence on training standards appeared first o

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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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Opinion: Real-time vital signs data: a hidden source of value in medical AI

STAT

If data represents the next gold rush for health care, a vast treasure trove of it slips away every day. The increased enthusiasm for AI has led to significant investments in novel solutions for health care, with data coming from a variety of sources such as medical charts, imaging, literature, guidelines, and the like. A largely untapped source of valuable data is staring health care practitioners like myself right in the face: monitors that track vital signs.

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PBMs will face House committee grilling next week

pharmaphorum

The House Committee on Oversight and Accountability will quiz leaders of pharmacy benefit managers (PBMs) at a hearing next week, amid scrutiny of the sector's role in rising healthcare costs in the US.The hearing – scheduled for 23rd July – is part of an ongoing investigation by the committee into PBMs' alleged anticompetitive practices launched last year and spearheaded by chairman James Comer (R-Ky).

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STAT+: Novartis not ready to admit a $3 billion mistake

STAT

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. Hello! It’s so damn hot. Apologies for the delay in delivery this morning, but I wanted to include a Novartis-pelabresib update from its earnings announcement. It’s the lead item below.

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J&J IRA pricing offer is in, as it sticks with 2025 guidance

pharmaphorum

J&J has three of its top-selling drugs in Medicare pricing negotiations but does not expect a major hit to its finances next year

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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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STAT+: Pharmalittle: We’re reading about Gilead’s CMO leaving, Novartis hedging on a drug, and more

STAT

Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because we recall a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us.

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OTC nasal sprays reduce infection and cut antibiotic use, suggests study

The Pharmacist

Over the counter (OTC) nasal sprays can reduce the length of upper respiratory tract infection by around 20%, and cut antibiotic risk by more than a quarter, a large scale study published in The Lancet has found. Two nasal sprays that trap, neutralise or reduce viruses in the nose or throat were compared to the […] The post OTC nasal sprays reduce infection and cut antibiotic use, suggests study appeared first on The Pharmacist.

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The biotech news stories you need to know today

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. Today, we discuss the latest with Novartis — the company reported earnings today and fielded questions about the myelofibrosis drug it got through buying MorphoSys.

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Boehringer backs Brainomix AI software for lung fibrosis

pharmaphorum

Boehringer Ingelheim has joined forces with digital health firm Brainomix on a project to improve the care of people with fibrosing lung diseases

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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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FDA launches new rare disease innovation hub

Pharmaceutical Technology

The new hub will act as a central point of connection and engagement for the rare disease community for FDA-related concerns.

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Clinical development rates are falling - but it’s not all bad news

pharmaphorum

While clinical development rates are falling, there is still hope in the Phase I bio sector. Learn more about the potential opportunities and positives in this challenging trend.

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How to Transition to a New CDMO Smoothly

Drug Patent Watch

Transitioning to a new Contract Development and Manufacturing Organization (CDMO) can be a complex and challenging process.

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Merdad Parsey will leave Gilead next year

pharmaphorum

Gilead Sciences' chief medical officer Merdad Parsey has said he will leave the company in early 2025

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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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FOPE and FABA to host Human Error Reduction Workshop in Hyderabad

Express Pharma

The Federation of Pharma Entrepreneurs (FOPE), a key advocate for India’s small and medium-sized pharmaceutical enterprises, in collaboration with the Federation of Asian Biotech Associations (FABA), is set to host “Human Error Reduction Workshop/Training” on July 19th, 2024, at the Marigold Hotel in Hyderabad. This event is meticulously crafted for Pharma/BioPharma professionals in fields such as Research and Development, Production, Warehouse, Quality Control, Quality Assuran

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EMCrit ShadowBoxing – Casey Parker Rural Medicine Critical Care Case

EMCrit Project

A great rural medicine critical care cards case EMCrit Project by Scott Weingart, MD FCCM.

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Union Health Minister J P Nadda reviews regulation of drugs, cosmetics and medical devices

Express Pharma

Union Health Minister J P Nadda, in a recent comprehensive review of India’s drugs, cosmetics, and medical devices regulatory landscape, underscored the necessity for the country to align its regulatory framework with global standards to uphold its position as the ‘Pharmacy of the World’ Joined by Union Health Secretary Apurva Chandra, DCGI Dr Rajeev Singh Raghuvanshi, and senior officials from CDSCO and the Union Health Ministry, Nadda emphasised the urgency of elevating regul

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Roche’s oral GLP-1 receptor agonist shows promising early weight loss results in phase 1

Outsourcing Pharma

Rocheâs recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.

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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.