Thu.May 08, 2025

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Bill Gates to accelerate spending at his foundation — then wind it down

STAT

Philanthropist Bill Gates announced Thursday that he will wind down his massive charity in 20 years, doubling spending over that time to accelerate the work it hopes to achieve. Gates made the announcement on the 25th anniversary of the launch of the Gates Foundation, the third-largest player in international philanthropy. He said the foundation would spend $200 billion between now and 2045, when its operations will wind down.

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Lupin gains USFDA nod for Raltegravir Tablets USP, 600 mg

Express Pharma

Lupin announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg of Merck Sharp & Dohme. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity.

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Opinion: An evidence-based way to make Medicaid less bureaucratic and more efficient

STAT

As a primary care physician serving Medicaid patients, I recently witnessed a preventable hospitalization that perfectly illustrates America’s health care dysfunction. My homebound patient with heart failure needed a routine lab test to adjust their medication. While commercially insured patients can access electronic lab orders, my patient’s Medicaid plan contracted exclusively with a laboratory requiring physical forms by mail.

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RFK Jr launches database project to explore autism causes

pharmaphorum

A project to use federal databases to identify the "root causes of autism" has been launched by HHS, but there are concerns about its credibility

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Viatris’ new form of old pain drug scores in large trials

BioPharma Dive

A version of meloxicam designed to work faster has beat out a placebo in two late-stage studies focused on post-surgical acute pain. Viatris now plans to file for approval this year.

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Majority of Europeans trust technology to improve healthcare, Johnson & Johnson survey finds

Pharmafile

A global survey by Johnson & Johnson MedTech has revealed that a majority of Europeans are willing to share their health data in exchange for more personalised care signalling growing public trust in the role of technology in healthcare. Conducted between August and September 2024, the survey gathered responses from both the general public […] The post Majority of Europeans trust technology to improve healthcare, Johnson & Johnson survey finds appeared first on Pharmafile.

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We are well-aligned to capitalise on the CDMO opportunity

Express Pharma

India may today account for less than 23 per cent of the pharma CDMO market today but has the potential to grow from $3.5 billion to $25 billion. Dr Abdelaziz Toumi, CEO, Lupin Manufacturing Solutions (LMS), explains to Viveka Roychowdhury how LMS is aligning long-term strategies, repositioning key assets, lining up investments in new modalities and leveraging Indias API ecosystem to capitalise on this opportunity.

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Boehringer advances oral therapy for geographic atrophy

pharmaphorum

Boehringer Ingelheim has started a phase 2 trial of a drug that could offer the first oral drug for geographic atrophy, a major cause of sight loss.

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Gilead, bracing for tariffs, joins peers in US drug production push

BioPharma Dive

The company added to a recent flurry of pledges by pharmaceutical companies, promising $11 billion in new capital and operational investments in U.S. drug manufacturing.

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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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From Barriers to Bridges: Rethinking Medication Access for 2025

Drug Channels

Todays guest post comes from Mike Cohn, Vice President, Network Operations at CoverMyMeds. Mike shares key takeaways on patient access and affordability from CoverMyMeds 2025 Medication Access Report. He focuses on the systemic fragmentation that exists across payers, providers, and pharmacies. Mike explains how these silos delay treatment and lead to increased out-of-pocket costs.

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FDA Announces ‘Aggressive’ AI Implementation Timeline

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Enterprise Risk Management (ERM): A critical imperative for India’s pharma sector

Express Pharma

The Indian pharmaceutical industry is one of the largest globally, known for its significant role in the production of generic drugs, contributing around 20 per cent of the global supply by volume. The industry is crucial in meeting global healthcare needs, especially in producing affordable medicines. However, the sector faces several supply chain challenges, affecting both domestic and international operations.

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Roche to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years

World Pharma News

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche's already significant US footprint with 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions, and are expected to create more than 12,000 new jobs, including nearly 6,500 construction jobs, as well as 1,000 jobs at new and expanded facilities.

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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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Adding SYLOID® Mesoporous Silica to Improve Run Time and Yield for Micronization Processes

PharmaTech

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID mesoporous silica with your APIs.

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STAT+: Democrats urge Republicans to target Medicare Advantage ‘upcoding’ instead of cutting Medicaid

STAT

As Republicans in Congress debate ways to cut Medicaid so they can fund tax breaks, Democrats are pushing them in a different direction: cut excess spending in Medicare Advantage instead. Five senators, including Bernie Sanders (I-Vt.) and Elizabeth Warren of Massachusetts, and 36 lawmakers in the House, told top Republicans Thursday that Medicare Advantage is rife with “wasteful spending.

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Alnylam keeps pushing the rare disease paradigm as RNAi promises even wider indications

PharmaVoice

With another rare disease approval under its belt, Alnylam is still revving up the R&D engines for new indications.

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STAT+: 5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review

STAT

The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of Americans. Calling it a “historic first,” FDA commissioner Marty Makary said on Thursday that the AI tool will be deployed across all of the agency’s review offices by the end of June, following the completion of

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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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Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

BioPharma Dive

Across hundreds of published papers, CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might push for higher standards in the review of medicines under his division's purview.

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Inside the world of internet peptides

STAT

A constellation of social media wellness influencers, YouTubers, and podcasters have been extolling the health benefits of peptides. There seems to be a peptide for just about anything you could dream of. Want to lose weight? There are GLP-1s, of course. Would you like to have a year-round tan? You could give melanotan a shot. Have a nagging sports injury?

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4 more biotechs cut staff amid market tumult

BioPharma Dive

Vor Bio, Korro Bio, Insitro and Rallybio revealed plans to lay off chunks of their respective workforces in the latest job cuts for a sector struggling to hold its financial footing.

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STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use

STAT

Medicare drug plans significantly boosted coverage of biosimilar versions of the Humira rheumatoid arthritis medicine this year, but nearly all of them failed to take steps that would encourage greater use of these alternative treatments, a new government watchdog report finds. The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies.

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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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Supply chain leadership: Stepping into the spotlight

Express Pharma

The line between disorder and order lies in logistics, says Sun Tzu, the Chinese warrior, philosopher and author in his renowned war treatise. He points out that even the strongest army or best plan will fail without proper management, transportation, and resource coordination. Modern businesses face the same realityeven the strongest business strategy will fail without a robust supply chain.

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Cancer before age 50 is increasing. A new study looks at which types

STAT

Cancer before age 50 is rare, but increasing, in the United States and researchers want to know why. A new government study provides the most complete picture yet of  early-onset cancers , finding that the largest increases are in breast, colorectal, kidney and uterine cancers. Scientists from the National Cancer Institute looked at data that included more than 2 million cancers diagnosed in people 15 to 49 years old between 2010 and 2019.

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Trust is Built on Data: Preserving the FDA’s Evidence-Based Approach to Interchangeable Biosimilars

Safe Biologics

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) In a recent CBS News interview, newly appointed FDA Commissioner Dr. Marty Makary called for more robust clinical evidence before recommending the latest COVID-19 booster shots. Theres a void of data, Dr. Makary said, underscoring a renewed focus on restoring public trust through a commitment to rigorous, evidence-based evaluation.

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STAT+: Insitro, an AI biotech founded by Daphne Koller, lays off staff

STAT

Insitro, the closely watched AI biotech founded by the Stanford professor and entrepreneur Daphne Koller, said Thursday it was laying off 22% of its staff, or around 60 people.  It’s part of a series of cuts that have hit well-backed startups over the last couple years, amid a prolonged downturn in biotech fundraising. A few startups have shut down altogether.

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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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Shionogi aims to buy tobacco giant's pharma unit for $1bn

pharmaphorum

Shionogi has reached a $1.

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Judge deals blow to compounding pharmacies

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, we’ve got more news today about Vinay Prasad — let’s get into it.

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FDA announces generative AI pilot and rapid rollout plans

pharmaphorum

FDA announces generative AI pilot and rapid rollout plans Jonah.

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