STAT

OCTOBER 1, 2024

New guidelines to force device manufacturers to make pulse oximeters more equitable for patients with darker skin have not been released by the Food and Drug Administration, despite agency officials saying for months new rules would be issued by Sept. 30.  It has been nearly four years since a group of physicians published clear evidence that pulse oximeters, the widely used fingertip devices that measure blood oxygen levels and are crucial in emergency and critical care, often missed low o

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PharmaVoice

OCTOBER 1, 2024

Mark your calendars for the most important industry conferences in 2025.

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STAT

OCTOBER 1, 2024

A year ago last week, Jeanne Marrazzo stepped into a very big pair of shoes.  Marrazzo became the first new director of the National Institute of Allergy and Infectious Diseases in decades, taking over a job held for 38 years by Anthony Fauci, whose long-term status as a science god in Washington gave way to Covid-19 fall guy in some quarters during and after the pandemic.

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PharmaVoice

OCTOBER 1, 2024

The president and CEO of Biocom California discusses the state’s strengths and weaknesses, current and emerging hubs, and the industry’s future.

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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

Communication

STAT

OCTOBER 1, 2024

Often, women with sickle cell disease are told not to have kids. They might come to an appointment, happily pregnant, only for the doctor to tell them they shouldn’t be. They might be preparing for a scheduled C-section when their OB-GYN says that this pregnancy has gone smoothly but the next one could kill them. The illness is associated with an increased risk of serious pregnancy complications, which warrants a discussion — but sometimes that discussion can blur the line between

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BioPharma Dive

OCTOBER 1, 2024

The company’s official launch comes five months after major investors such as Atlas Venture and Bain Capital filed a Shanghai stock exchange filing for a biotech named “Hercules CM NewCo.

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BioPharma Dive

OCTOBER 1, 2024

Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies' research progress. Here’s a list of conferences to watch in 2025.

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STAT

OCTOBER 1, 2024

Atlas Venture and Bain Capital Life Sciences are making their next bet in the buzzy obesity field, launching a new startup led by a chief executive hot off of his third acquisition deal. Atlas, Bain, and RTW Investments announced Tuesday that they have co-led a $400 million Series A financing for a new Boston-area startup company called Kailera Therapeutics.

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Drug Patent Watch

OCTOBER 1, 2024

In the complex world of intellectual property and pharmaceutical development, understanding the intricacies of patent term extension (PTE) is crucial for innovators and businesses alike. One of the most critical aspects of PTE is calculating the regulatory review period, which can significantly impact the lifespan and profitability of a patented product.

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STAT

OCTOBER 1, 2024

A U.S. lawmaker is pushing the Food and Drug Administration to provide more guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in a highly important agency registry known as the Orange Book. In a letter dated Monday, Sen. Bill Cassidy (R-La.) accused the FDA of failing to take responsibility for an issue that has long vexed a growing number of people over the implications for the availability of lower-cost gen

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Diabetes 266

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Drug Patent Watch

OCTOBER 1, 2024

Have you ever wondered why some medications seem to cost an arm and a leg, while others are surprisingly affordable? The answer often lies in the complex world of drug patents. Let’s dive into the fascinating realm of pharmaceutical intellectual property and explore when drug patents expire. Drug patents are a crucial aspect of the pharmaceutical industry.

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STAT

OCTOBER 1, 2024

CVS Health said Monday that it will lay off about 2,900 people amid pressure from investors to cut costs and improve its financial performance. And more dramatic changes could be coming soon. A spokesperson for the health care giant, which has long been based in Woonsocket, R.I., and operates health insurer Aetna in Hartford, confirmed the cuts, which will primarily fall on corporate roles.

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The Pharmacist

OCTOBER 1, 2024

The Pharmacy First October threshold will remain at 20 clinical pathway consultations, rather than rising to 30 as originally planned. This means that pharmacies will need to conduct a minimum of 20 Pharmacy First clinical pathway consultations in October to be eligible for the monthly payment. Community Pharmacy England (CPE) said it had 'been discussing […] The post October Pharmacy First thresholds lowered to 20 appeared first on The Pharmacist.

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Community Pharmacies 111

STAT

OCTOBER 1, 2024

Top of the morning to you, and a fine one it is, despite the dreary gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom 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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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.

Drug Patent Watch

OCTOBER 1, 2024

In the world of healthcare, few topics spark as much debate and confusion as prescription drug pricing. Have you ever wondered why that little pill in your medicine cabinet costs so much? Let’s dive into the intricate world of pharmaceutical economics and uncover the factors that determine the price tags on our prescriptions.

Drug Pricing 104

Drug Pricing 104

STAT

OCTOBER 1, 2024

As a public health professional, I want people to have access to the health care they need to improve their quality of life. For years I researched available treatments for specific illnesses to determine their safety and efficacy, growing to become an advocate for the development of new treatments for those living with rare diseases. Yet, for too long, I had no idea the Food and Drug Administration convenes groups of experts, known as advisory committees or ad comms, to review trial data for tr

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The Pharmacist

OCTOBER 1, 2024

The government has introduced caps on the maximum number of Pharmacy First clinical pathway consultations that each pharmacy can claim payment for. The caps are based on each pharmacy's monthly average earlier in the year, and will be in place from October to December this year. Use our interactive tool below to find out your […] The post See how your pharmacy compares as Pharmacy First caps introduced appeared first on The Pharmacist.

Community Pharmacies 99

Community Pharmacies 99

STAT

OCTOBER 1, 2024

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. Abridge unveils new research collaborative with Epic, Stanford In an announcement shared exclusively with STAT, ambient documentation darling Abridge says it’s launching a new research effort to examine the technology’s impact on five dimensions: “ clinic

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Documentation 238

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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.

Express Pharma

OCTOBER 1, 2024

Global pharma major Lupin today announced that it has signed a distribution agreement with Scope Ophthalmics Ireland (SCOPE) for the registration and marketing of a Moist Heat Mask, a Tea Tree Oil Eyelid Cleansing Gel and Tea Tree Oil Eyelid Wipes of the OPTASE range, in Mexico. The OPTASE range is a safe, tested and expert recommended 3-step regime to help tackle the cause and symptoms of eye conditions such as Dry Eyes, Blepharitis and Meibomian Gland Dysfunction (MGD).

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STAT

OCTOBER 1, 2024

The race to supply obesity drugs is so competitive that one startup is already striking a deal for commercial manufacturing even when its lead candidate is still in early stage testing. Metsera, a biotech focused on obesity drugs that came out of stealth this year, said Tuesday that it is partnering with drug manufacturer Amneal Pharmaceuticals to produce injectable and oral obesity treatments for clinical trials and commercialization.

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pharmaphorum

OCTOBER 1, 2024

Learn how Advanced Clinical ensures compliance through the Functional Point of Contact (FPOC) story. Explore their innovative approach to maintaining regulatory standards.

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STAT

OCTOBER 1, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! We’ve got a vice presidential debate tonight. What do you think of the decision by CBS not to have moderators fact-check the candidates like ABC did for the presidential debate? (Watch this space tomorrow for a recap of health and medicine topics that come up.

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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.

Express Pharma

OCTOBER 1, 2024

Emcure Pharmaceuticals recently achieved a milestone on World Heart Day by entering the Asia Book of Records for creating the ‘Largest Heart Shaped Structure Formed Using Wish Cards by Doctors’ in Mumbai. The structure, formed with contributions from over 5,000 doctors across India, symbolises a unified commitment to combating heart disease.

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STAT

OCTOBER 1, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. I’m still in denial that it’s the first day of October, but alas we have some biotech news to get to.

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Drug Pricing Drug Development 201

Express Pharma

OCTOBER 1, 2024

ARS Pharmaceuticals’ Neffy, the first needle-free epinephrine nasal spray, is poised to significantly impact the treatment of life-threatening allergic reactions like anaphylaxis following FDA approval in August 2024. With ease of use paired with a strong patient-assistance program, Neffy is set to disrupt the epinephrine market, according to GlobalData.

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Pharma Times

OCTOBER 1, 2024

Janssen-Cilag therapy becomes the first single tablet combination therapy for PAH in europe

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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.

Pharmacy Management

Express Pharma

OCTOBER 1, 2024

Sun Pharmaceutical Industries and Philogen S.p.A. have announced a global licensing agreement for the commercialisation of Philogen’s specialty product, Fibromun. Fibromun, an anti-cancer immunotherapy, is being investigated in registration trials for the treatment of soft tissue sarcoma and glioblastoma. Under the terms of the agreement, Sun Pharma will have exclusive worldwide rights to commercialise Fibromun.

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Pharmaceutical Companies Pharmaceutical Companies 90

pharmaphorum

OCTOBER 1, 2024

Stay up to date with the latest developments in the pharma and biotech industry with a focus on companies like Eli Lilly, UCB, Chiesi, Orbital Therapeutics and more. Get insights and updates on Changing Faces in September 2024.

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Outsourcing Pharma

OCTOBER 1, 2024

The Barcelona-based startup Sequentia Biotech has raised â10 million ($11 million) in a Series A round to finance the development of its omics-based technology for use in biomedicine, agritech and food.

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Drug Patent Watch

OCTOBER 1, 2024

To find Key Starting Materials (KSMs) for pharmaceutical Active Pharmaceutical Ingredients (APIs), you can follow these steps: Remember that the availability and sourcing of KSMs can vary depending on the specific API and regulatory requirements in different countries. It’s essential to ensure that any KSMs used in pharmaceutical manufacturing meet the necessary quality and regulatory standards.

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Pharmaceutical Manufacturing 82

Outsourcing Pharma

OCTOBER 1, 2024

Artificial intelligence has emerged as a potential solution to inconsistent reporting of adverse events, which to this day remains one of the main challenges in the field of pharmacovigilance.

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