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STAT+: Gilead won U.S. approval for HIV prevention shot, but when will low-income countries gain sufficient access?

STAT

Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug , the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem. As far as Gilead is concerned, the groundwork exists to meet that goal. Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries.

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FDA to speed reviews for drugs supporting ‘national interests’

PharmaVoice

A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

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Sun Pharma appoints Kirti Ganorkar as Managing Director, announces key managerial shifts

Express Pharma

Sun Pharmaceutical Industries announced the appointment of Kirti Ganorkar as the Managing Director to succeed Dilip Shanghvi, effective September 1, 2025, with the entire business and all functions reporting to him. This appointment is subject to approval of the shareholders at the upcoming Annual General Meeting. Ganorkar has been heading India Business at Sun Pharma since June 2019.

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FDA approves twice-yearly shot of Gilead drug for HIV prevention

BioPharma Dive

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

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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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‘HIV-ending’ drug could be made for just $25 per patient a year, say researchers

The Guardian - Pharmaceutical Industry

As regulator prepares to approve lenacapavir in the US, campaigners are urging the manufacturer, Gilead, to make it ‘available and affordable for all who need it’ A drug with the potential to “end the HIV pandemic” will launch in the US this week – as a new study reveals it could be sold for 1,000 times less than its possible price tag. Lenacapavir, given as a twice-yearly injection, can prevent someone from being infected with HIV, according to clinical trial results.

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The Top 15 Specialty Pharmacies of 2024: How PBMs, Health Systems, and Independents Are Shaping the Market (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: What’s Next for Retail Pharmacy: Data, Debate, and Disruption. I’ll be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research, and President of 3 Axis Advisors. Click here to see the original post from April 2025. Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs.

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Sheffield scientists and AstraZeneca develop new machine learning model for inverse protein folding

Express Pharma

In a study published in Nature Machine Intelligence , researchers from the University of Sheffield, in collaboration with AstraZeneca and the University of Southampton, have developed a machine learning framework that demonstrates improved accuracy in inverse protein folding compared to existing methods. Inverse protein folding involves identifying amino acid sequences that form a desired 3D protein structure.

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Bharat Biotech acquires licence for GSK’s Shigella vaccine development

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

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Genentech's Bittenbender named board chair at BIO

pharmaphorum

Genentech's Fritz Bittenbender becomes chair of the Biotechnology Innovation Organization at a challenging time for the sector.

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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: Medicaid cuts would devastate mental health, substance use treatment services in red states

STAT

When House Republicans voted in the wee hours of the morning of May 22 to cut approximately $700 billion from Medicaid , they moved one step closer to rendering dangerously vulnerable the millions of Medicaid recipients struggling with mental illness and substance use disorder. Medicaid, which covers more than 72 million Americans, is the single largest payer of behavioral health services , which includes mental health and substance use disorder treatment.

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A Message from President Annagrace Malamsha for Commonwealth Pharmacists Day 2025​

Commonwealth Pharmacists Association

A Message from President Annagrace Malamsha for Commonwealth Pharmacists Day 2025 Dear Colleagues, It brings me and the Commonwealth Pharmacists Association (CPA) great pleasure to observe Commonwealth Pharmacists Day 2025.

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Lupin signs licensing deal with Sino Universal Pharmaceuticals to supply Tiotropium DPI in China

Express Pharma

Lupin has entered into a licence and supply agreement with Sino Universal Pharmaceuticals (SUP) for the commercialisation of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule, in the Chinese market. The product is indicated for the treatment of chronic obstructive pulmonary disease (COPD). According to the terms of the agreement, SUP will be responsible for securing regulatory approvals required to market Tiotropium DPI in China.

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AI-powered orchestration: Bringing the benefits to personalized therapy

Pharmaceutical Technology

Supply chains for a new generation of therapies are complex, costly, and require meticulous management to ensure patient safety and regulatory compliance. AI can transform cell and gene therapy (CGT) orchestration by automating manual processes, improving productivity, enhancing supply chain visibility and improving scalability.

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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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Rethinking Glucose Monitoring With AI and Nanomaterials

Pharma Marketing Network

By Max Kopp Diabetes care is entering a new era—yet even in 2025, continuous glucose monitors (CGMs) remain out of reach for millions. Despite a decade of innovation, current CGMs often fail to meet the needs of everyday people with type 2 diabetes, particularly those in under-resourced or underserved communities. High costs, skin invasiveness, and insurance limitations act as real barriers, not just for adoption, but for long-term engagement.

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STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service

STAT

LONDON — A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer’s drugs do not justify their high prices, meaning the medicines won’t be made available through the National Health Service. The decision by the U.K.’s cost-effectiveness watchdog reflects how health authorities in different parts of the world have taken different approaches with the drugs, which are the first to have shown they can slow the progression of the dis

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FDA to speed reviews for drugs supporting ‘national interests’

BioPharma Dive

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

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Levicept presents new LEVI-04 data at EULAR

Pharma Times

Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs Levicept presents new LEVI-04 data at EULAR by John Pinching | 12th Jun 2025 | News Biotech firm shares phase 2 findings on novel osteoarthritis treatmen Levicept has presented new data from its phase 2 trial of LEVI-04 at the European Congress of Rheumatology (EULAR 2025).

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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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Novo Nordisk teams up with NVIDIA on AI models

pharmaphorum

Novo Nordisk and tech giant NVIDIA have joined forces on a new project that aims to speed up drug discovery using generative AI.

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Gerresheimer enhances pharma packaging registration with comprehensive product database

Express Pharma

Gerresheimer, a systems and solutions provider for the pharmaceutical and biotech industry, has introduced a web-based product database designed to streamline the selection and registration of primary plastic packaging for medicinal products. By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies.

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Dismissed members of CDC vaccine committee call Kennedy’s actions ‘destabilizing’

STAT

NEW YORK — All 17 experts recently dismissed from a government vaccine advisory panel  published an essay  Monday decrying “destabilizing decisions” made by U.S. Health Secretary Robert F. Kennedy Jr. that could lead to more preventable disease spread. Kennedy last week announced  he would “retire”  the entire panel that guides U.S. vaccine policy.

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Can ‘reputational pull’ save biotech from pharma’s image problem?

PharmaVoice

A reputation is tough to build and easy to bruise. For drugmakers stuck in reputational limbo, embracing a clear direction and forward-thinking strategy can foster a rosier image.

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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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FDA approves UroGen’s Zusduri to treat recurrent bladder cancer

Pharma Times

Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs FDA approves UroGen’s Zusduri to treat recurrent bladder cancer by Emily Kimber | 17th Jun 2025 | News Approximately 59,000 LG-IR-NMIBC patients experience recurrent disease every year in the US The US Food and Drug Administration (FDA) has approved UroGen Pharma’s Zusduri (mitomycin intravesical solutio

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FDA clears Nuvation's first product Ibtrozi, for lung cancer

pharmaphorum

Nuvation is set to launch its first commercial product after the FDA approved its ROS1 inhibitor Ibtrozi as a treatment for ROS1-positive lung cancer.

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Merck’s Enflonsia to gain competitive advantage in paediatric RSV prophylaxis market with lack of weight-based dosing: GlobalData

Express Pharma

Merck’s Enflonsia (clesrovimab) has received FDA approval for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. Enflonsia, is a long-acting monoclonal antibody (mAb) that can provide protection through a typical 5-month RSV season with a 105mg dose, regardless of weight.

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STAT+: More universities open to private equity deals, and emerging companies turn to new targets

STAT

This is the online version of our BIO 2025 newsletter. Get more BIO updates directly to your inbox by signing up here , and sign up for our morning biotech news roundup newsletter here. Hello all, I have a fresh double shot of espresso in hand, which I’m sure would please my colleague  Ed Silverman , aka Pharmalot. BIO has been busy this year.

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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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Changing the PAP Model

Pharmaceutical Commerce

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Pharmacy must grow as ‘key clinical provider’, says NHSE primary care lead

The Pharmacist

Community pharmacy must ‘grow’ as a ‘key clinical service provider’ within primary care, NHS England’s national director for primary care and community services has suggested. Speaking at the NHS Confed Expo healthcare conference in Manchester on Wednesday, Dr Amanda Doyle said she recognised that community pharmacy felt ‘underwater currently’ but that she wanted its clinical […] The post Pharmacy must grow as ‘key clinical provider’, says NHSE primary care lead appeared first on The Pharm

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US lawmakers seek ban on DTC advertising

pharmaphorum

US Senators Bernie Sanders and Angus King have introduced a bill that seeks to ban direct-to-consumer (DTC) advertising by the pharma industry.

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