Tue.Oct 01, 2024

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Q&A: NIAID’s Jeanne Marrazzo speaks on bird flu, mpox, and succeeding Anthony Fauci

STAT

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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California is a life sciences leader. Joe Panetta has been one of its most vocal advocates.

PharmaVoice

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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Why do Black Americans get more aggressive cancers?

STAT

Across all kinds of cancer, Black Americans have higher rates of mortality and, often, more aggressive forms of the disease. A growing body of research suggests the reasons may not have to do with African ancestry as much as social and environmental factors like racism, housing discrimination , and — according to a new study — exposure to pollution.

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Kailera Therapeutics emerges from stealth with $400M for obesity drugs

BioPharma Dive

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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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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FDA misses target date for releasing rules to make pulse oximeters more equitable

STAT

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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October Pharmacy First thresholds lowered to 20

The Pharmacist

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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Top pharma and biotech conferences 2025

PharmaVoice

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

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STAT+: $400 million for an obesity drug startup? A new venture is a sign of the times

STAT

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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Dr Reddy’s Laboratories completes acquisition of Nicotinell and related brands

Express Pharma

Dr Reddy’s Laboratories has announced the completion of its acquisition of Haleon plc’s global portfolio of nicotine replacement therapy (NRT) brands outside the United States. This follows the earlier announcement on 26 June 2024, regarding the purchase made through Dr Reddy’s wholly-owned subsidiary, Dr Reddy’s Laboratories SA, Switzerland. The transaction includes the acquisition of Northstar Switzerland SARL, a Haleon group company, along with its subsidiaries, North Star OpCo Limited (UK) a

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STAT+: U.S. lawmaker urges FDA to clarify drug patent listings in a key government registry

STAT

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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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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Ensuring compliance - The Functional Point of Contact (FPOC) story

pharmaphorum

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+: The health care issues we’re watching in tonight’s VP debate

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Not so Midwest nice Vice presidential debates don’t usually matter much, but this one might. It’s probably the last chance for a one-on-one matchup between the two parties’ tickets in a very close race.

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Calculating the Regulatory Review Period for Patent Term Extension: A Comprehensive Guide

Drug Patent Watch

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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Opinion: STAT+: Five things FDA ad comm members want

STAT

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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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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Microbiome startup Sequentia Biotech heralds “new era” in omics with €10 million round

Outsourcing Pharma

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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STAT+: Pharmalittle: We’re reading about CVS exploring a breakup, obesity drug coverage, and more

STAT

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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When Do Drug Patents Expire: Understanding the Lifecycle of Pharmaceutical Innovations

Drug Patent Watch

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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Struggle to regulate health AI, Epic’s antitrust challenges, and more AI news

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. 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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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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How are prescription drug prices determined?

Drug Patent Watch

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.

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What is Marburg virus? Who is the new Fauci? And is your 3-year-old getting enough sleep?

STAT

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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Lupin signs distribution agreement with scope Ophthalmics for eye care products in Mexico

Express Pharma

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+: An obesity startup wastes no time: With drugs in early testing, Metsera lines up manufacturing

STAT

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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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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Emcure Pharmaceuticals sets Asia record for largest heart-shaped structure on World Heart Day

Express Pharma

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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The latest obesity drug updates happening right now

STAT

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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Authenticx CPO Eric Prugh on the impact of AI technology in pharmacovigilance

Outsourcing Pharma

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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See how your pharmacy compares as Pharmacy First caps introduced

The Pharmacist

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.

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ARS Pharmaceuticals’ Neffy poised to disrupt epinephrine market as first needle-free nasal spray: GlobalData

Express Pharma

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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The top biopharma conferences in 2025

BioPharma Dive

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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Sun Pharma and Philogen sign global licensing agreement for Fibromun

Express Pharma

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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5 FDA decisions to watch in the fourth quarter

BioPharma Dive

Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.

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Complete our survey and help make the case for change

The Pharmacist

The Pharmacist’s news team is looking to uncover the current state of play across the profession, both within community pharmacy and general practice. But we need your help. We have launched a short survey in the hope of collecting much-needed insight on workload, recruitment, training, medicines shortages, pharmacy closures and more. Take our survey here […] The post Complete our survey and help make the case for change appeared first on The Pharmacist.

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Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi

Pharmaceutical Technology

Otulfi is the fourth Stelara biosimilar approved in the US but will not launch until early 2025.