Tue.Jan 30, 2024

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STAT+: Ultima Genomics launching high-end DNA sequencers that can read genome for $100

STAT

Ultima Genomics, an upstart some observers have called a “ dark horse ” in the world of DNA sequencing, will soon launch a line of high-power instruments that can read a human genome for as little as $100, the company’s leadership told STAT. The sequencer, dubbed the UG 100, is a $1.5 million machine that can read up to 20,000 human genomes a year.

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CAR-T developers respond to FDA black box warning

PharmaVoice

Despite a recent safety warning from the FDA, companies such as BMS and J&J stress that the benefits of their cancer therapies still outweigh the risks.

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STAT+: Can Wegovy treat depression as well as obesity? New research looks to GLP-1 drugs for mental illnesses

STAT

Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder. Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious.

Diabetes 357
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CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

BioPharma Dive

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

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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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The U.S. hasn’t seen syphilis numbers this high since 1950. Other STD rates are down or flat

STAT

NEW YORK — The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults. But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.

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Co-inventor of AZ COVID-19 shot pivots from vaccine-linked name

PharmaVoice

Barinthus Biotherapeutics wants to be known for more than its pandemic ties, CEO Bill Enright said.

Vaccines 147

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Non-opioid drug from Vertex cuts pain in major trial tests

BioPharma Dive

The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.

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STAT+: CMS will use outcomes-based agreements in bid to help Medicaid pay for sickle cell gene therapies

STAT

In response to concerns over multimillion-dollar price tags for new gene therapies for sickle cell disease, the U.S. government on Tuesday announced a long-awaited “access model” designed to blunt the cost that state Medicaid programs would pay for these curative treatments. Two therapies recently approved by health regulators cost $2.2 million and $3.1 million, respectively, and have raised alarms over the ability of financially strapped state Medicaid programs to absorb the expen

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FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

Pharmafile

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, which allows them to initiate a phase 1 trial of GC012F in the US for the early-line treatment of multiple myeloma (ELMM). GC012F is “an autologous CAR T therapeutic candidate dual-targeting B cell maturation antigen […] The post FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment appeared first on Pha

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STAT+: Vertex pain drug results met with measured optimism — and questions — by observers and experts

STAT

Late-stage trial results for a pain medication developed by Vertex Pharmaceuticals reinforced experts’ sense that the drug was both safe and offered modest pain relief. But the findings also prompted fresh debate on Tuesday about how widely used the therapy would be should it win regulatory approval. The company reported that its small molecule drug, VX-548, outperformed placebo in a pair of pain relief trials that recruited patients who had gotten an abdominoplasty (tummy tuck) or bunion

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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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Digital prescriptions added to NHS App

pharmaphorum

From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.

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STAT+: Vertex’s closely-watched pain relief drug succeeds in late-stage trials — with a catch

STAT

A pain relief drug developed by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field. In a pair of randomized, placebo-controlled Phase 3 trials for patients with pain after a tummy tuck or bunion surgery, the drug showed statistically significant pain reduction compared to placebo,

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Cour gets $105M, pharma help to ‘reprogram’ autoimmune disease

BioPharma Dive

Roche, Pfizer and Bristol Myers Squibb have all invested in the startup, which is using nanoparticle technology to retrain the body’s immune system.

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STAT+: Sophisticated phishing and deepfakes: How generative AI brings new threats for hospitals

STAT

The ubiquity of AI tools like ChatGPT could be a boon to hospitals eager for diagnostic aids or administrative assistants that can flag crucial medical details and ease the burden of repetitive tasks. But security experts say they can just as easily be harnessed by malicious hackers to exploit an industry known for outdated cyber protections. Health leaders tell STAT they’re assessing risks, recruiting cybersecurity teams and updating training materials to warn staff about increasingly so

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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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The future of pharmacovigilance – beginning the shift to AI-driven processes

pharmaphorum

Explore the future of pharmacovigilance as we begin to shift towards AI-driven processes. Learn about the advancements in AI models, the role of GenAI, and how experts are leveraging these technologies to improve drug safety and monitoring.

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STAT+: Cour Pharmaceuticals, a biotech taking aim at autoimmune diseases, raises $105 million

STAT

John Puisis was dubious when he first heard about the autoimmune science being developed by a coalition of scientists from Northwestern University and the University of Sydney. The group was developing a sort of Trojan horse that it hoped could be used to treat autoimmune diseases. They had developed polymer nanoparticles that could mimic dying cells, which the immune system won’t attack, but will naturally pull from the bloodstream and throw into the body’s waste collection and re

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Over 10,000 pharmacies in England offering Pharmacy First from today

The Pharmacist

A total of 10,265 community pharmacies in England will begin offering the new Pharmacy First service from today – marking what has been described as a ‘step-change’ for pharmacies, patients and the public. Among leaders welcoming the new service today is Prime Minister Rishi Sunak who said that with the launch of Pharmacy First the […] The post Over 10,000 pharmacies in England offering Pharmacy First from today appeared first on The Pharmacist.

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How an immunological Trojan horse could treat disease

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, everyone. Damian here with some breathlessly anticipated news from Vertex Pharmaceuticals, an exit interview from an FDA lifer, and the debut of the $100 genome.

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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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US bill paints some Chinese biotechs as security threats

pharmaphorum

Legislation filed in the US is seeking to block Chinese biotech companies from federal contracts on the grounds they are a national security concern

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STAT+: Here are the new hotspots for Boston-area biotech

STAT

Move over, Kendall Square. Folks in the biotech nerve center may shudder at the notion. But the next miracle drug for lung cancer or epilepsy is just as likely to emerge from Arsenal Yards in Watertown or the shadow of Fenway Park. The spread of the biotech sector — to smaller clusters in Boston, Watertown, Waltham, and beyond — picked up speed in recent years as Cambridge became congested and the cost of lab space skyrocketed.

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Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters

Drug Patent Watch

The recent paper published in PLOS ONE presents a novel approach for efficiently retrieving a substantial number of patents related to specific technologies. The authors enhance an automated patent landscaping… The post Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters appeared first on DrugPatentWatch - Make Better Decisions.

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Philips to stop selling sleep apnea machines in U.S. under tentative agreement with FDA, DOJ

STAT

WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million. Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

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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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CHMP meeting highlights: January 2024

European Pharmaceutical Review

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week. The CHMP recommended Exblifep (cefepime/enmetazobactam) as a treatment for complicated urinary tract infections, including pyelonephritis, hospital-acquired pneumonia, including ventilator associated pneumonia, and for treating bacteraemia caused by the aforementioned infections.

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Getting down to the nitty gritty of actively creating healthier societies

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Stuart Cooper, CEO of Adelphi Group, about Anthropy – a yearly event that aims to spark innovation and foster fresh thinking among diverse leaders – and about creating healthier societies, about biopharma’s role in that, including implementation of preventative methods in ameliorating global health.

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Immunotherapy drug achieves trial-first in fifty years

European Pharmaceutical Review

Results from a Phase III, randomised, placebo-controlled clinical trial have for the first time in fifty years, demonstrated an overall survival benefit from an adjuvant therapy in kidney cancer. Pembrolizumab targets a “checkpoint” pathway that is key in enabling cancer cells to avoid being destroyed by the immune system. As a result, the immunotherapy drug supports the immune system’s T cells fight tumours, the researchers highlighted.

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PulmCrit wee: Polypharmacy in the ICU – when in doubt, deprescribe

EMCrit Project

Polypharmacy is technically defined as taking five or more medications on a daily basis. Polypharmacy is increasingly becoming the norm among adults, due to several factors (an aging population, increasing numbers of medical problems, and increasingly complex regimens available to treat chronic disorders such as heart failure). Indeed, the term “polypharmacy” is arguably antiquated now […] EMCrit Project by Josh Farkas.

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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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International consortium identifies biomarkers for cardiovascular disease in diabetes

Pharma Times

Type 2 diabetes is estimated to affect 462 million people worldwide

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NHS App launches digital prescription feature

The Pharmacist

A new feature of the NHS App will allow patients to view their prescription information digitally and collect their medicines from any pharmacy using a barcode from today. The government said the move would help ‘ease pressures’ on pharmacists and GPs. NHS England (NHSE) is carrying out a full rollout of the added prescription functionality […] The post NHS App launches digital prescription feature appeared first on The Pharmacist.

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First human subject receives a Neuralink brain implant

pharmaphorum

Elon Musk’s Neuralink company has said it has implanted its wireless brain implant device into a human being for the first time

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Treatment approved for Hong Kong's second most common cancer

Outsourcing Pharma

With colorectal cancer (MRC) being the second biggest cancer type in Hong Kong, it is positive news that Hutchmed has received marketing approval for its Elunate (fruquintinib) small molecule treatment.

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GSK seeks to extend RSV vaccine use in adults aged 50-59

Pharmaceutical Technology

The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.

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