Wed.Nov 20, 2024

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STAT+: New details on a risky medical device show need for more FDA transparency, researchers say

STAT

Tonya Brand was horrified to find a piece of metal poking out of her inner thigh while relaxing at her house in Georgia in 2011. She had no idea what it could be.  It was only after extensive imaging that her doctors realized what had happened: A medical device that had been implanted in her two years earlier to catch blood clots had broken and was now migrating to different parts of her body.

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We should call for a new minister to improve men and boys’ health

The Pharmacist

What more can we do to improve men’s health? Pharmacist Michael Achiampong shares his personal viewpoint about improving the health of men and boys. Men and boys’ health – physical, mental and emotional – has rocketed up the healthcare agenda and public awareness like never before.1,2 There is new impetus for some long-running initiatives such as Movember3 […] The post We should call for a new minister to improve men and boys’ health appeared first on The Pharmacist.

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STAT+: RFK Jr. is exploring a plan to upend Medicare’s physician payments system

STAT

WASHINGTON  — People close to Robert F. Kennedy Jr. are exploring a proposal that could upend how physician payment is determined in America, four sources familiar with the process told STAT.

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Latest UKHSA figures show rise in both antibiotic use and resistance

The Pharmacist

Antibiotic use rose by 2.4% year-on-year in 2023 and prescribing levels are now in line with those seen in 2019, according to national surveillance data published by the UK Health Security Agency (UKHSA). The increases were seen across the majority of antibiotic groups, with penicillins accounting for the most frequently prescribed antibiotic group in primary […] The post Latest UKHSA figures show rise in both antibiotic use and resistance appeared first on The Pharmacist.

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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: The term ‘vegetative state’ has no place in modern medicine

STAT

A stroke, a traumatic brain injury — at any moment, any one of us could leave behind our normal state of consciousness and start to require ’round-the-clock care. Sometimes, a patient displays regular cycles of wakefulness and sleep without regaining the capacity for normal voluntary action. This is a tragic situation for the patient’s family — but what, if anything, might the patient themselves be experiencing?

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Tran Pham: Breaking barriers and building biopharma solutions

Outsourcing Pharma

From discovering her knack for chemistry in high school to proving her expertise in male-dominated spaces, Tran Pham has built a dynamic career in biopharma.

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More Trending

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Pfizer bags EU okay for haemophilia drug Hympavzi

pharmaphorum

Pfizer's Hympavzi has become the first once-weekly subcutaneous treatment for people living with severe haemophilia B in the EU

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STAT+: AI in drug discovery is ‘nonsense,’ but call Schrödinger ‘AI’ if you want, says CEO

STAT

Schrödinger CEO Ramy Farid wants you to know that his company isn’t an AI company…but he’ll call it that if you want to. The company, founded in 1990, started out by making software that used the basic laws of physics to laboriously and exactly predict how molecules will interact with each other in space. Those calculations, rooted in the field of computational physics, needed lots of expensive and time-consuming computing power to run, and many people abandoned those t

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Flagship, Pfizer alliance yields two more startup deals

BioPharma Dive

Pfizer will work with Ampersand Biomedicines and Montai Therapeutics to find drugs for obesity and lung cancer, respectively, adding to collaborations it previously formed with other Flagship startups.

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Opinion: Paying a visit to ‘Mom & Dad’s Nipple Factory’

STAT

When Randi Johnson was undergoing treatment for breast cancer, her husband, Brian, often felt at a loss to help. But then, when he and Randi met with a surgeon to discuss reconstructing her breast, he was struck by something he could do. The Midwestern father of five, a lifelong tinkerer, decided to make his wife the best possible prosthetic nipple.

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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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NICE blames companies for breakdown in Enhertu talks

pharmaphorum

Discussions aimed at making AstraZeneca and Daiichi Sankyo's Enhertu available to breast cancer patients on the NHS have been abandoned

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STAT+: Doubling down on its strategy, Pfizer names its head of oncology as new research chief

STAT

Pfizer said its chief oncology officer, Chris Boshoff, will head all of the company’s research and development efforts in addition to keeping his current duties overseeing the company’s scientific and commercial efforts in cancer. Boshoff replaces Mikael Dolsten, who led research and development at the drug giant for 15 years and who announced his plans to retire in July.

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Glox Therapeutics Awarded £1M PACE Grant to Accelerate Development of Precision Antibiotics Against Antimicrobial-resistant Pathogens

Pharmafile

20 November 2024 – Glasgow, UK –: Glox Therapeutics, a company pioneering the development of precision antibiotic therapies based on naturally occurring bacteriocins, today announced it has secured £1 million in grant funding from PACE (Pathways to Antimicrobial Clinical Efficacy), one of the UK’s largest public-private initiatives targeting early-stage antimicrobial medicines and diagnostic discovery.

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Investors tell Silence Therapeutics to shush 

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. Today, we meet Pfizer’s new chief scientific officer, ponder why the stock for Silence Therapeutics dropped despite promising data, and see that pharma executives aren’t too worried about Robert F.

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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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MSD says subcutaneous Keytruda matches IV form

pharmaphorum

MSD's subcutaneous formulation of top-selling cancer drug Keytruda was non-inferior to the current intravenous version in a head-to-head trial

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A new device for delivering drugs without needles draws inspiration from the elegant squid

STAT

Doctors have been using needles as a way to inject people with drugs since the 1600s. Today they’re often used for biologic drugs, which are too large to deliver via pills because they would be dissolved by stomach acid. Now a group of bioengineers is hoping to give drug delivery an update with a device that draws inspiration from cuttlefish and other sea creatures.

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Chasing new ‘checkpoints,’ startup Valora emerges from a Nobel winner’s lab

BioPharma Dive

Built around research by Stanford scientist Carolyn Bertozzi and MIT researcher Jessica Stark, Valora Therapeutics is designing drugs to target glyco-immune checkpoints.

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STAT+: Pharmalittle: We’re reading about Pfizer’s new R&D head, Merck and J&J job cuts in China, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not particularly appealing. And what better way to make the time fly than to keep busy.

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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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Ardena’s expanded nanomedicine facility granted full GMP approval

Pharma Times

The Netherlands facility is designed to handle a wide range of nanomedicines, including lipid-based nanoparticles

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STAT+: Kura licenses leukemia drug to Japanese drugmaker

STAT

Kura Oncology has signed a global partnership with the Japanese drugmaker Kyowa Kirin to develop and sell Kura’s experimental treatment for acute leukemia, the companies said Wednesday.  Kyowa is paying $320 million to Kura in exchange for global licensing rights to the drug, called ziftomenib, which is in a late-stage clinical trial for a genetically defined type of advanced leukemia.

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Sage wilts as Huntington's prospect flunks trial

pharmaphorum

Sage Therapeutics' run of bad news has continued with a failed phase 2 trial of dalzanemdor as a treatment for Huntington's disease

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Sage’s string of research failures continues

BioPharma Dive

Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.

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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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AVPN launches Climate x Health: Lighthouse for Asia fund

Express Pharma

AVPN, the largest network of social investors in Asia, has launched the “Climate x Health: Lighthouse for Asia” Fund with support from the Bayer Foundation. Announced during the Singapore Pavilion session at COP29 in Baku, Azerbaijan, the USD 5-million fund aims to assist non-profit organisations utilising climate innovations to develop scalable solutions to protect vulnerable communities from the health impacts of climate change.

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Key Challenges Facing the Pharma Industry in 2025

Pharmaceutical Commerce

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, details the types of regulatory pressures and factors surrounding rising R&D costs that will affect the pharmaceutical industry.

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Innovative method could address a major limitation in fluorescence microscopy

European Pharmaceutical Review

Researchers in Israel have developed a way to obtain high-resolution imagery using megapixel fluorescence microscopy without needing specialist equipment. The technique enables clear images of dense and challenging targets to be captured. It can correct computational scattering, which is one of the main limitations in fluorescence imaging, according to the paper that discusses the study findings.

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Initial Results Demonstrate Moderately Strong Relationship Between NAPLEX Advantage and Future NAPLEX Performance

National Association of Boards of Pharmacy

In January 2024, NABP launched the NAPLEX Advantage assessment tool which provides colleges of pharmacy and students with a testing experience that mimics the North American Pharmacist Licensure Examination® (NAPLEX®). Like the NAPLEX, the NAPLEX Advantage is administered in a secure and proctored environment. Comprised of 100 questions that were previously used on the NAPLEX, the NAPLEX Advantage is built using the same examination blueprint as the NAPLEX.

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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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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant* — FDA recently issued a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices , which describes chemical characterization methods that may be used to demonstrate biocompatibility of a medical device as an alternative to conducting certain biological testing.

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A next-generation mindset: Veeva Commercial Summit 2024

pharmaphorum

The Veeva Commercial Summit 2024 explores the next-generation mindset that is shaping the future of the commercial sector. Get insights, network, and stay ahead of the curve with this overview of Day One.

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Navigating the Complex Landscape: Key Challenges in Biosimilar Development

Drug Patent Watch

The pharmaceutical industry is constantly evolving, and one of the most exciting areas of growth is the development of biosimilars. These biological products, designed to be highly similar to existing approved biologics, offer the promise of more affordable treatment options for patients. However, the journey from concept to market is fraught with challenges.

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EMA’s strategy for speeding up drug approvals in the EU

pharmaphorum

The European Medicines Agency (EMA) has implemented a strategy to accelerate drug approvals in the EU. Learn more about their initiatives and how they are streamlining the process for faster access to medicines.

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The Science Behind Generic Drug Development: A Deep Dive

Drug Patent Watch

Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.