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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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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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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‘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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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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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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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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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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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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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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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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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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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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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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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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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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Re-elected von der Leyen pledges EU measures for biotech

pharmaphorum

Ursula von der Leyen highlights biotech and AI as key sectors in speech as she is re-elected as President of the European Commission

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Sanofi announces expansion of its Global Capacity Center in Hyderabad

Express Pharma

Sanofi Healthcare India announced the expansion of its Global Capacity Centre (GCC) in Hyderabad, with plans to invest €400 million over the next six years, with €100 million by 2025. Over the next two years, this GCC (hub) will expand to host up to 2600 employees, making it, reportedly the largest of Sanofi’s four global hubs. “Sanofi’s four Global Capacity Centers are strategic Hubs across the Globe that give the company a competitive edge in delivering best-in-class enterprise solutions.

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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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Discover how Marwan Fathallah is transforming DIA and hoping to revolutionize global healthcare

Outsourcing Pharma

At the DIA 60th annual conference in San Diego, senior editor Liza Laws from Outsourcing Pharma had the opportunity to sit down with Marwan Fathallah, President and CEO of DIA.

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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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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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Study reveals new AI tool predicts recurrence of prostate cancer by a decade

Pharma Times

The most commonly diagnosed cancer in men in the UK leads to over 12,000 annual deaths

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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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Nipro's $397.8M investment brings 232 new jobs to Greenville, NC with exciting new facility

Outsourcing Pharma

Japanese medical devices company, Nipro Medical Corporation, a giant in the healthcare and medical device industry, has announced a major investment of $397.8 million to establish its first North American manufacturing center of excellence in Greenville, North Carolina.

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Johnson & Johnson’s Q2 2024 net earnings drop 12.8% to $4.6bn

Pharmaceutical Technology

Johnson & Johnson has reported a 12.8% decrease in net earnings for Q2 2024, with figures falling to $4.6bn from $5.3bn in Q2 2023.

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CordenPharma invests €900M in expanding peptide platform to meet GLP-1 drug demand

Outsourcing Pharma

CordenPharma, a US-based contract development and manufacturing organization (CDMO), will be making a â900 million investment over the next three years into expanding its peptide technology platform at its US and Europe sites.

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Centaur launches chronic heart failure generic drug In the US

Express Pharma

Centaur Pharmaceuticals fully integrated announced the launch of generic version of chronic heart failure drug Corlanor in the United States. Centaur received 180-day exclusivity on generic Ivabradine hydrochloride. The Mumbai-based company, through its marketing partner Ingenus Pharmaceuticals, launched Corlanor in a dosage of 5mg and 7.5mg tablets in the US.

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Top 5 CDMOs driving advanced therapies to market amid rising demand and challenges

Outsourcing Pharma

Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry â a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward the market.

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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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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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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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Caroline Shleifer on founding RegASK and her journey in science and regulatory affairs

Outsourcing Pharma

Caroline Shleifer is the founder and CEO of RegASK, the global, AI-driven solution for curated regulatory intelligence.

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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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