Tue.Aug 27, 2024

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21 cases of little-known Oropouche virus detected in U.S.

STAT

Nearly two dozen people in the United States have been confirmed to have contracted the Oropouche virus during travels outside the country this summer, the Centers for Disease Control and Prevention reported Tuesday. A previously little-known virus, Oropouche has garnered headlines in recent weeks with reports of a small number of deaths and a possible link to congenital malformations in babies infected in the womb.

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As pharma’s AI revolution gets underway, ‘hallucinations’ pose a great risk

PharmaVoice

While AI, machine learning and large language models can distill huge amounts of information, they sometimes make mistakes. New technologies could rebuild that trust.

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STAT+: To help migraine patients — and sell more medicines — major drugmakers turn to telehealth

STAT

In 2021, Katey Frederking had reached the end of her rope. The 29-year-old was struggling with frequent migraines, which started after a concussion from a fall on an icy patch near her home in Chicago. The medications she had been prescribed weren’t working, her doctor wasn’t listening, and she was facing several months of wait time before she could see a new neurologist.

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Fact Sheet: Physicians Oppose S.2305 -That Would Make All Biosimilars Interchangeable

Safe Biologics

In August, ASBM released an updated fact sheet on Senate Bill S. 2305 “the Biosimilar Red Tape Elimination Act”, sponsored by Sen. Mike Lee (R-UT), shoing how physicians overwhelmingly oppose its provisions. From the Fact Sheet: U.S. Physicians Strongly Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars While 89% of U.S. physicians are confident in the safety and efficacy of biosimilars, 69% also say the physician and patient should determine which biologic to use, not a

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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 importance of reducing the financial burden of participating in clinical trials

STAT

Scientific advancements have helped millions of people living with cancer, heart disease, arthritis, obesity, and other diseases. Essential for the development of new therapies are the thousands of people who volunteer to participate in clinical trials every year, helping to characterize the safety and effectiveness of treatments and vaccines. They raise their hands not knowing if the trial will help, only knowing they will be part of a journey toward possible breakthroughs that will improve or

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ASBM Submits Comments on FDA Draft Guidance Proposing Eliminating Switching Studies for Interchangable Biosimilars

Safe Biologics

On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.

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AstraZeneca investment to increase biologic capacity in Sweden

European Pharmaceutical Review

AstraZeneca has announced the largest single investment in its Sweden Biomanufacturing Center in Södertälje, since the facility opened in 2021. The additional $135 million investment will increase the biopharmaceutical facility area by 50 percent. An existing building within AstraZeneca in Södertälje is set to be expanded by 2,700m 2 , the company explained.

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Opinion: To stop mpox from becoming the next pandemic, we must address global vaccine inequities

STAT

In early 2022, I cared for one of the first patients with mpox in Massachusetts. As an infectious diseases physician, I remember the deep uncertainty I felt, and the fear in my patient’s eyes as a painful rash spread over their body. We were in uncharted territory — there were no proven treatments, and the number of cases was rapidly increasing.

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Lilly rolls out Zepbound vials at a discount price

BioPharma Dive

The launch of a single-use vial form of the popular weight loss medicine could help Lilly improve supply and compete with telehealth companies offering compounded versions.

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STAT+: Centene eliminates brokers’ commissions for Medicare drug plans

STAT

Health insurer Centene will not pay any commissions to brokers and agents who help people sign up for next year’s Medicare prescription drug plans. “We have made a difficult decision — effective Jan. 1, 2025 — to cease new and renewal commissions for [Medicare Part D plans] beginning with the 2025 plan year,” Centene’s WellCare subsidiary said last Friday in an email sent to brokers, which was obtained by STAT.

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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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Pfizer launches DTC service for migraine, COVID drugs

BioPharma Dive

The platform is similar in concept to a service launched this year by Eli Lilly, and aims to give consumers easier access to Pfizer’s migraine, COVID-19 and flu treatments.

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Pfizer and Lilly want to sell you drugs directly

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, and thank you for sticking with us ahead of Labor Day weekend. I’ll be visiting Austin for the weekend and would welcome any recommendations!

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Bharat Biotech launches oral cholera vaccine HILLCHOL to address global shortage

Express Pharma

Bharat Biotech (BBIL) has launched HILLCHOL (BBV131), an oral cholera vaccine developed under license from Hilleman Laboratories. The vaccine, designed to combat cholera, addresses the global shortage of oral cholera vaccines (OCVs), which currently faces a deficit of approximately 40 million doses annually due to limited manufacturing sources. HILLCHOL has been tested through pre-clinical and Phase I, II, and III clinical studies, demonstrating safety, immunogenicity, and non-inferiority to exi

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Glucose monitors, mpox vaccine inequity and effects of LGBTQ+ restrictions

STAT

STAT’s coverage of chronic health issues is supported by a grant from  Bloomberg Philanthropies. Our financial supporters  are not involved in any decisions about our journalism. Good morning! If you noticed that the upside down smiley face in yesterday’s newsletter item on the DNC looked absolutely massive compared to the text … no you didn’t.

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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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National campaign launches to end prostate cancer postcode lottery

Pharma Times

Over 135,000 people have signed a petition to prioritise a national screening programme

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STAT+: Pharmalittle: We’re reading about Lilly cutting Zepbound’s price; Pfizer selling direct to consumers, and more

STAT

Good morning, everyone, and how are you today? We are just fine, thank you, especially since clear, blue skies and a slightly cool breeze are enveloping the Pharmalot campus this morning. To celebrate, we have given the official mascots new treats and are treating ourselves to a joyful cup of stimulation. Our choice today is pecan pie — sweets for the sweet, you know.

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Six in ten pharmacies losing money, reports CPE

The Pharmacist

Almost two-thirds of pharmacy premises in England are reportedly losing money, a survey by Community Pharmacy England (CPE) has revealed. And 16% of pharmacy respondents predicted they will have to close within a year. The survey, carried out between early March and April 2024, involved over 900 pharmacy owners representing more than 6,100 (around 60% […] The post Six in ten pharmacies losing money, reports CPE appeared first on The Pharmacist.

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Pfizer joins Lilly in direct-to-consumer drive

pharmaphorum

Pfizer has become the latest big pharma group to launch a web-based platform that opens up a direct-to-consumer channel for medicines access.This morning, the company announced the launch in the US of PfizerForAll, a digital platform that it says provides access to same-day appointments with healthcare professionals – in-person or via a $35 telehealth visit – along with home delivery of medicines and diagnostics, vaccination appointments, and payment support.

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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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Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution

Express Pharma

Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1 per cent , to market a generic equivalent of Alphagan P Ophthalmic Solution, 0.1 per cent, of AbbVie Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

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GPhC to 'green' its regulatory framework

The Pharmacist

Pharmacists and pharmacy premises will need to prove they are working towards net zero targets and can provide sustainable pharmacy care, under new plans from the pharmacy regulator. The General Pharmaceutical Council (GPhC) said it will incorporate sustainability in the standards that it holds pharmacists and pharmacy premises to. As part of its carbon net […] The post GPhC to 'green' its regulatory framework appeared first on The Pharmacist.

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Roche gets EU nod for subcutaneous PNH drug PiaSky

pharmaphorum

Roche's PiaSky is the first therapy for rare blood disorder PNH that can be given by monthly subcutaneous injection in the EU.

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With a new oncology head, Takeda revamps its R&D strategy

PharmaVoice

The company is using a “three-by-four” approach to sharpen its cancer R&D aims.

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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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J&J's Balversa is first pan-FGFR bladder cancer drug in EU

pharmaphorum

J&J's Balversa has been approved in the EU for advanced bladder cancer with FGFR3 genetic alterations after one line of prior therapy

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NHS 111 to offer mental health crisis support

The Pharmacist

NHS 111 will now provide direct support to patients experiencing a mental health crisis, NHS England has announced. The service expansion announced today means that patients can now call 111, select the mental health option and speak to a mental health professional if they are in a crisis. NHS staff will then guide them through […] The post NHS 111 to offer mental health crisis support appeared first on The Pharmacist.

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After FDA no, Regeneron gets yes from EU on odronextamab

pharmaphorum

Regeneron's Ordspono (odronextamab) for non-Hodgin lymphoma (NHL) is cleared in EU five months after being turned down by the FDA

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McKesson to buy controlling stake in Florida Cancer Specialists’ unit for about $2.5 billion

Express Pharma

Drug distributor McKesson recently said that it would buy a controlling stake in community cancer centre Florida Cancer Specialists & Research Institute’s (FCS) business and administrative services unit for $2.49 billion in cash. McKesson would own roughly a 70 per cent stake in the unit, Core Ventures, which manages non-clinical administrative functions such as providing operational and advisory support services to FCS clinics across Florida.

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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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Nasal powder shows promise in boosting immune defense

Outsourcing Pharma

The INNA-051 formulation is designed to enhance the bodyâs natural immune response, targeting individuals aged 60 and over who are at increased risk for complications from respiratory viral infections.

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How to deal with fragmented data - A $12.9 million challenge

pharmaphorum

Learn how to effectively deal with fragmented data by leveraging Veeva Open Data in this informative white paper. Gain insights on how to streamline data management processes and improve data quality.

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IIL develops needle-free intranasal COVID-19 booster vaccine

Express Pharma

Indian Immunologicals Limited (IIL) has announced the development of a live-attenuated, needle-free intranasal booster vaccine against SARS-CoV-2. The vaccine was created using codon deoptimization technology in collaboration with Griffith University, Australia. The research on this vaccine was published in the journal Nature Communications on August 26, 2024.

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How to Manage Cholesterol in Your Pharmacy

PioneerRx

71 million Americans have high cholesterol, according to Johns Hopkins Medicine. Another 25 million have elevated cholesterol levels, which significantly.

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Singapore approves mpox vaccine as it adds border infection checks

Pharmaceutical Technology

Unlike its close neighbour Thailand, Singapore has not yet confirmed an mpox clade Ib case.

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