Thu.Jun 06, 2024

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‘Concern is real’ about long Covid’s impact on Americans and disability claims, report says

STAT

The Covid pandemic has been called a “mass-disabling event” since early on — the kind of once-in-a-generation public health crisis that could shape millions of people’s lives forever. But while more people self-identified as disabled since the pandemic began, applications for disability benefits have stayed level, according to data from the Social Security Administration.

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A ‘widening gap’ in access to new cancer meds drives efforts from City of Hope and Bristol Myers

PharmaVoice

Cancer care is improving so quickly that receiving newer medications can be difficult — City of Hope’s wide oncology network and a 10-year commitment from Bristol Myers Squibb offer some solutions.

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Federal officials and physician groups express outrage over revelations of recent coercive sterilizations

STAT

Federal officials, medical organizations, and reproductive health advocacy groups have expressed outrage in response to STAT’s recent investigation revealing that women with sickle cell disease have felt pressured into sterilizations as recently as 2017 and 2022. Some said they knew of other contemporary instances of tubal ligations with questionable consent — in people with severe disabilities, for instance, or situations in which patients didn’t understand that the procedu

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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

BioPharma Dive

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

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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: Close a regulatory loophole in the ACA to provide vaccine access for all Americans

STAT

The Patient Protection and Affordable Care Act , (generally known as the ACA), was signed into law in 2010. It expanded access to affordable, quality health care, and today is helping 45 million people — the highest total on record — be covered by health insurance. The law included long-overdue policy changes to ensure that Americans have access to recommended preventive care, which is critical to avoiding preventable illnesses and the health care spending associated with them.

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May 2024 Newsletter

Safe Biologics

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM was well represented at the conference, with several member groups were in attendance including the International Cancer Advocacy Network (ICAN), and the Global Colon Cancer Association (GCCA).

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Statin tops NHS prescribing once again as total number of items continues to increase

The Pharmacist

Atorvastatin was once again the most dispensed chemical substance by community pharmacies in England last year, while the number of items dispensed has continued to increase year on year since 2020/21. Cardiovascular drugs accounted for 30% of all items prescribed by the NHS in the UK and dispensed in the community in England 2023/24, according […] The post Statin tops NHS prescribing once again as total number of items continues to increase appeared first on The Pharmacist.

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STAT+: Psychedelics companies see FDA panel’s vote as a growth opportunity, not a roadblock

STAT

A day after a panel of advisers to the Food and Drug Administration expressed deep concerns about the use of MDMA to help treat post-traumatic stress disorder, companies working to develop other psychedelics said their optimism had not been dimmed — and that the concerns provided a clearer blueprint for what it might take to get such a drug approved.

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Pharmacy technicians will not provide Pharmacy First under PGD changes, says CPE

The Pharmacist

Changes to allow pharmacy technicians to supply medicines will not apply immediately and will not affect Pharmacy First, Community Pharmacy England has confirmed. The Human Medicines Regulations were amended last week to enable registered pharmacy technicians to supply medicines under patient group directions (PGDs). But although the amendments will come into effect from 26 June, […] The post Pharmacy technicians will not provide Pharmacy First under PGD changes, says CPE appeared first on

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STAT+: At BIO, signs Congress’ tough stance on China is chilling biotech relationships

STAT

SAN DIEGO — U.S. legislation that seeks to restrict American biotechs from working with certain Chinese firms and suppliers is for now just that — a proposal, not a law. But the looming bill’s impact was clearly visible at this year’s meeting of the industry’s largest trade group. A number of biotech companies in attendance at the meeting of the Biotechnology Innovation Organization told STAT they’re actively looking to strike deals with U.S.

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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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Joint letter urges political parties to commit to pharmacy funding

The Pharmacist

Four pharmacy organisations have called for ‘fair, sustainable funding’ for the community pharmacy sector, in an open letter to political parties ahead of the general election. Community Pharmacy England (CPE), the Company Chemists’ Association (CCA), the National Pharmacy Association (NPA), and the Royal Pharmaceutical Society (RPS) said in the letter that ‘the sector is in […] The post Joint letter urges political parties to commit to pharmacy funding appeared first on The Pharmacist.

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STAT+: FDA reviewers ask if approval of Lilly’s Alzheimer’s drug should be restricted to a smaller group

STAT

Scientists at the Food and Drug Administration have two big questions about Eli Lilly’s experimental Alzheimer’s drug donanemab ahead of a panel of outside experts that it is convening on Monday: Should the patients who receive the medicine be limited based on PET scans of a protein called tau that Eli Lilly used as a key criteria for trying to determine whether they should receive the drug?

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Buoyed by new obesity data, Structure files $476m offering

pharmaphorum

Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million

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Novovax will be able to supply Covid-19 vaccines this fall

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 how psychedelics companies are responding to the negative ad comm vote on Lykos’ therapy, results of Zepbound in MASH, and the fate of Novovax this fall.

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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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Agomab receives FDA Orphan Drug Designation for AGMB-447 in idiopathic pulmonary fibrosis

Express Pharma

AGMB-447 is an inhaled lung-restricted ALK5-inhibitor currently in a Phase 1 clinical trial Agomab Therapeutics announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AGMB-447, its inhaled, small molecule inhibitor of ALK5. Agomab is evaluating AGMB-447 as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF) in a Phase 1 clinical trial.

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STAT+: Cigna wins case to block former executive from jumping to CVS

STAT

CVS Health viewed Amy Bricker as a potential CEO. But she won’t be going to the health care conglomerate anytime soon. A federal appeals court has ruled Bricker, a former high-ranking executive at Cigna, cannot jump to CVS because it would violate her noncompete agreement that she signed while at Cigna. The appeals court’s decision backs up what a district court had previously ruled.

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GSK accelerates oligonucleotide platform and pipeline medicines with acquisition of Elsie Biotechnologies

World Pharma News

GSK plc (LSE/NYSE: GSK) today announced that it has acquired Elsie Biotechnologies, a San Diego-based private biotechnology company dedicated to unlocking the full potential of oligonucleotide therapeutics, for up to $50 million (approximately £39 million). Oligonucleotides have a unique ability to modulate gene expression, making them an attractive modality to address a significant proportion of therapeutic targets that are not amenable to traditional small molecules or biologics.

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Do digital physical therapy solutions work? New report has some insights

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. A new  report  from the  Peterson Health Technology Institute  suggests virtual physical therapy services could decrease health care spending for payers that invest in them.

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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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Mexican man dies in first human case of H5N2 bird flu

pharmaphorum

A man in Mexico has died in what the WHO has said is the first lab-confirmed human infection with the H5N2 strain of bird flu

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STAT+: Pharmalittle: We’re reading about the aftermath of FDA vote on MDMA, rising pharma layoffs, and more

STAT

Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus again. 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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Combination therapy may hold potential for severe viral hepatitis

European Pharmaceutical Review

Final Phase IIb data has confirmed the potential of bulevirtide 10mg in combination with pegylated interferon alfa-2a (PegIFN) as a finite therapy for adults with chronic hepatitis delta virus (HDV), according to Gilead Sciences. The new data is from the MYR204 study which investigated the efficacy and safety of the first-in-class entry inhibitor bulevirtide alone and together with PegIFN, in these patients with compensated chronic HDV infection.

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Listen: Psychedelics at the FDA, ASCO recap, & MorphoSys update

STAT

How did advisers react to the first psychedelic therapy to go before the Food and Drug Administration? And did the American Society of Clinical Oncology meeting surpass expectations? We discuss that and more in this week’s episode of “The Readout LOUD.” STAT colleague Meghana Keshavan joins us to dissect Lykos Therapeutics’ meeting with an FDA advisory committee.

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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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WuXi facility boosts bioprocessing capacity with new bioreactors

European Pharmaceutical Review

WuXi Biologics has successfully installed three new sets of 5,000L single-use bioreactors at its MFG20 drug substance manufacturing facility in Hangzhou, China. Fitted in the facility’s second drug substance line, the contract research, development and manufacturing organisation (CRDMO) explained that this move enhances manufacturing capability at the site, by increasing capacity from 8,000L to 23,000L.

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Data needed to forge the link between AI and mRNA

Pharmaceutical Technology

While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.

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Telix prices $200m IPO in big week for radiopharma financing

pharmaphorum

Trio of radiopharma financings this week, as Telix files $200m US IPO, ITM raises $202m in a private round, and AstraZeneca invests in CDMO Nucleus.

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Revised pharmacovigilance guidance for human vaccines open for public consultation

Express Pharma

Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines” was released for public consultation by Central Drug Standard Control Organisation (CDSCO). This update aims to align the guidance with the New Drugs and Clinical Trials Rules, 2019, and has been developed in collaboration with the AEFI Secretariat and IP

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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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Amgen preps Uplizna filing for a second indication

pharmaphorum

Amgen's Uplizna could become the first FDA-approved treatment for rare disease IgG4-RD, after showing efficacy in the phase 3 MITIGATE trial

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Underutilized Opportunities: Exploring Patent Term Extensions for Medical Devices

Drug Patent Watch

In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the… Source

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FDA and CluePoints extend collaboration to enhance clinical trial integrity and safety

Outsourcing Pharma

Yesterday (June 5) CluePoints, providers of established statistical and AI-driven software solutions, and the Food and Drug Administration (FDA) announced an extension to their long-standing collaboration.

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CDC recommends first post-exposure antibiotic for STIs

pharmaphorum

CDC recommends doxyPEP as first post-exposure antibiotic for STIs including syphilis, gonorrhoea and chlamydia

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Alchemab receives funding boost for Parkinson’s research

Pharma Times

Innovative antibody discovery could lead to new Parkinson’s treatments

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