Mon.Nov 27, 2023

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STAT+: With biotech in a slump, the industry’s job market is upside down

STAT

After earning her doctorate in cell biology at the University of Pennsylvania in June, Sierra Collins did what many freshly minted Ph.D.s. do — she went looking for a job at a biotech company. But what was supposed to be a straightforward search has turned into an odyssey. Collins has applied for more than 53 positions (and counting). Like a good scientist, she’s gathering data along the way and uses a spreadsheet to track each company’s size and therapeutic focus, as well a

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As alcohol-related deaths climb, new drugs could curb the urge to drink

PharmaVoice

A drug developed by Kinnov Therapeutics halved alcohol consumption in heavy drinkers in a mid-stage study

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Opinion: The next Census could undercount the number of disabled Americans by 20 million

STAT

About 20 million disabled people will be erased if the U.S. Census Bureau moves forward with changes to disability data collection methods. That is because many disabled people will no longer be counted as disabled by the new questions the Census is proposing to use starting in 2025 with the annual American Community Survey (ACS). As disabled people, and as scholars who study disability measurement and use disability data for our research, we have grave concerns about this proposed change.

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SAEM Clinical Images Series: Utility of Bedside Ultrasonography

ALiEM - Pharm Pearls

A 24-year-old G1P0010 female with a PMHx of ovarian cyst (unknown laterality) and emergency contraceptive use 3 months prior presented with sudden onset abdominal pain (upper > lower) that awoke her from sleep four hours prior to presentation with associated nausea and mild lower back pain. The pain is 10/10, sharp, stabbing, and diffuse. Additionally, she reported trace white vaginal discharge at baseline.

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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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New research supports potential link between low-level lead exposure and liver injury

STAT

Nearly a decade on, the Flint water crisis still looms large in the minds of environmental toxin researchers. It was — and continues to be — evidence that not all communities in the United States are equally affected by environmental pollutants. “It’s true that they’re sort of ubiquitous, but they aren’t uniformly distributed.

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How EMD Serono plans to hit its lofty goals in R&D

PharmaVoice

One year ago, EMD Serono — Germany-based Merck KGaA’s U.S. healthcare business — set a goal to double R&D productivity in oncology, neurology and immunology, aiming to launch a new product or in a new indication about every one-and-a-half years. Achieving that goal would.

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Long COVID study expanded across Europe

European Pharmaceutical Review

Biotech Berlin Cures, a company focusing on neutralising functional autoantibodies (fAABs), is expanding its Phase II clinical trial on Long COVID (post-COVID syndrome). into a pan-European, multi-center collaboration. The study will provide “meaningful and robust results on the efficacy and tolerability” of its lead drug candidate BC 007 in individuals with Long COVID.

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STAT+: Springworks wins FDA approval for drug to treat desmoid tumors

STAT

The Food and Drug Administration on Monday approved the first treatment for people with desmoid tumors, a localized cancer that invades soft tissue and muscle. The new drug, called Ogsiveo, is made by Springworks Therapeutics. It’s the company’s first approved medicine. Desmoid tumors are fibrous growths that start in connective tissue and are often found in the abdomen, arms, legs, and torso.

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Legalized medical cannabis five years on - Releaf discusses how far the industry hasn't come

Outsourcing Pharma

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

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A new algorithm unveils CRISPR ‘treasure trove’

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Hope you had a peaceful holiday. Back to biotech, we discuss the tough job market, delight in some exciting early developments in CAR-T and CRISPR, and see further validation for the blockbuster anti-inflammatory drug Dupixent.

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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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GSK cancer drug Blenrep gets surprise trial win

BioPharma Dive

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

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STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

STAT

Just 3% of more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings, underscoring ongoing concerns about clinical trial transparency, according to a new analysis. More specifically, 47% of those trials, or more than 1,770, were registered in advance, while only 12% reported results in a registry, and only 48% published their findings.

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EVERSANA brings genAI to medical content approvals

pharmaphorum

EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.

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STAT+: Pharmalittle: Bioscience job market is upside down; Sanofi and Regeneron’s blockbuster Dupixent may find bigger market

STAT

Good morning, everyone, and nice to see you again after an extended break on this side of the pond. We hope your own respite was relaxing and invigorating, because that oh-so familiar routine of online calls and meetings and deadlines has predictably returned. But you knew this would happen, did you not? So time to fire up the coffee kettle and brew another cup of stimulation.

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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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Mesoblast files applications with US FDA for HLHS therapy

Pharmaceutical Business Review

The company has filed the applications based on Revascor’s data from a randomised, blinded, controlled prospective study carried out at a single centre in the US involving 19 children with HLHS. HLHS is a severe congenital heart disease where the left side of the heart does not fully develop, leading to a decrease in efficient pumping of oxygenated blood from the left ventricle to the rest of the body.

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Q&A: Building a More Resilient Medicines Supply Chain

Quality Matters

Q&A: Building a More Resilient Medicines Supply Chain In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Cadwallader, Ph.D. joins the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium to discuss the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages.

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MHRA launches online eligibility checker tool via the IRP

Pharma Times

The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog: Biosimilars

By Riëtte van Laack & Anne K. Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating the CPSA.

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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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Could stem cell therapy stabilise MS progression?

European Pharmaceutical Review

Injecting allogenic neural stem cells into the brains of patients living with progressive multiple sclerosis ( MS ) is safe and well tolerated, a a Phase I trial has shown, with the effects reported to last over 12 months. Findings from the study evaluating the advanced cell therapy treatment for progressive MS have been published in Cell Stem Cell.

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Steadfast Nutrition launches protein efficiency formula for protein deficiency

Express Pharma

Herbfast is a blend of 23.3 g of whey protein, natural herbs and spices, vitamin B complex, digestive enzymes, green tea extract, L-carnitine, and taurine Steadfast Nutrition has launched a protein supplement HerbFast Protein, calling it ‘India’s Protein Efficiency Formula’. HerbFast Protein is a blend of 23.3 g of whey protein, natural herbs and spices, vitamin B complex, digestive enzymes, green tea extract, L-carnitine, and taurine.

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Studies back role of community pharmacy in solving health challenges

The Pharmacist

The importance of the community pharmacy sector in addressing England’s health service challenges has been underlined by two recently published academic studies. The two peer-reviewed papers – Pharmacy users’ perceptions, awareness and future expectations of community pharmacy in England, and Professional stakeholders’ expectations for the future of community pharmacy practice in England – are based […] The post Studies back role of community pharmacy in solving health challenges appeared

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Cadila Pharma launches API manufacturing plant at Dahej

Express Pharma

Equipped with Distributed Control System (DCS) automation technology, the facility has been set up with an investment of Rs 200 crore Cadila Pharmaceuticals inaugurated its state-of-the-art Active Pharmaceutical Ingredients (API) Plant at Dahej in the Bharuch district. The facility, set up with an investment of Rs 200 crore, is equipped with the latest Distributed Control System (DCS) automation technology.

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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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New NHS software set to improve care for millions of patients

Pharma Times

Around £330m will be invested in the software over the next seven years - News - PharmaTimes

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Novo Nordisk invests 2.1 billion euros to expand the existing production site in France

Express Pharma

The investment will significantly increase the capacity of the manufacturing site, adding aseptic production and finished production processes and an extension of the current Quality Control Laboratory Novo Nordisk has announced the investment of more than 16 billion Danish kroner (2.1 billion euros) starting in 2023 to expand the existing production site in Chartres, France, for the current and future product portfolio within serious chronic diseases.

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FDA fast-tracks Genelux’s oncolytic virus-based ovarian cancer therapy

Pharmaceutical Technology

Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.

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Is GSK’s Blenrep heading for a renaissance?

pharmaphorum

A year after GSK pulled its BCMA-targeting antibody-drug conjugate (ADC) Blenrep from the US market as a later-line therapy for multiple myeloma, there are signs that the drug may still have a role to play earlier on in the treatment pathway.

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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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Service spec for Pharmacy First unveiled by NHS England

The Pharmacist

The service specification for the incoming Pharmacy First scheme has been published by NHS England. The service, due to start at the end of January 2024, will cover seven common conditions – earache, impetigo, infected insect bite, shingles, sinusitis, sore throat, and uncomplicated urinary tract infections in women – alongside the current elements of the […] The post Service spec for Pharmacy First unveiled by NHS England appeared first on The Pharmacist.

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Mylab and Ekincare to promote SII’s influenza nasal vaccine among corporates

Express Pharma

The joint effort between Mylab and Ekincare will enable businesses to incorporate NASOVAC-S4 into their employee wellness programs Mylab has announced a strategic partnership with Ekincare which is a corporate wellness and health benefits platform. This collaboration aims to promote NASOVAC-S4, influenza nasal vaccine developed by the Serum Institute of India (SII), among corporate entities.

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AI may spare breast cancer patients unnecessary treatments

World Pharma News

A new AI (Artificial Intelligence) tool may make it possible to spare breast cancer patients unnecessary chemotherapy treatments by using a more precise method of predicting their outcomes, reports a new Northwestern Medicine study. AI evaluations of patient tissues were better at predicting the future course of a patient’s disease than evaluations performed by expert pathologists.

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NHSE could suspend Pharmacy First delivery if AMR concerns emerge

The Pharmacist

Pharmacists could be suspended from delivering a Pharmacy First service if concerns over antimicrobial resistance (AMR) and patient safety emerge, NHS England (NHSE) has said. The service specification for Pharmacy First – which will roll out on 31 January 2024 – has now been published, including details of how NHSE intends to oversee the scheme. […] The post NHSE could suspend Pharmacy First delivery if AMR concerns emerge appeared first on The Pharmacist.

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Cultivating quality excellence in the clinical trials landscape

pharmaphorum

Cultivating quality excellence in the clinical trials landscape Mike.

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