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FDA Approves Nitisinone for Treatment of Alkaptonuria

Drug Topics

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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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Eli Lilly Adds Highest Doses of Zepbound to Online Pharmacy Platform

Drug Topics

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy Journal Submission of Articles Events Virtual Events Total Pharmacy Solutions Summit Business Business Strategies Patient Services Pharmacy Inv

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New report finds rampant abuse of the 340B program

PhRMA

A new analysis from ADVI shows how the federal government routinely neglected to provide oversight of the 340B program. While 99.7% of 340B providers escape scrutiny due to a lack of oversight, the majority of audits that are conducted reveal adverse findings, raising serious concerns.

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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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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 Approves mRNA-1345 Vaccine for Adults Aged 18 to 59 Years

Pharmacy Times

Moderna's mRNA-1345 vaccine gains FDA approval, enhancing protection against RSV for high-risk adults aged 18 to 59, following earlier approvals for older populations.

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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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Americans are paying a 26% freerider tax on medicines because other countries don’t pay their fair share

PhRMA

The United States leads the world in the research and development, manufacturing and access of innovative medicines. Today, more than half of global biopharmaceutical research and development happens in the United States alone. That’s not by accident: America’s innovation ecosystem is the best in the world, thanks to a policy environment that incentivizes innovation and rewards progress, and it supports workers, the economy and our patients.

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Can you drink coffee on Mounjaro?

The Checkup by Singlecare

If you rely on a cup (or two, or three) of coffee in the morning to jumpstart your body and mind for the day, whether or not you can continue enjoying it when starting a new medication may be one of the first questions you ask. It’s especially important when taking a long-term prescription, such as Mounjaro , a once-weekly injectable medication that treats Type 2 diabetes.

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Opinion: Six former CDC vaccine advisory committee chairs warn: U.S. risks losing access to life-saving immunizations

STAT

As former chairs of the CDC’s Advisory Committee on Immunization Practices ( ACIP ), we are deeply alarmed by the growing politicization of vaccines — a public health innovation that has saved 154 million lives globally. While politicization of science is not new, the escalating distrust in science across the political spectrum, and its intrusion into the vaccine ecosystem, now threatens the very infrastructure that has long protected Americans from infectious diseases.

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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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Q&A: How Innovation is at the Heart of this Independent Pharmacy’s Growth

Drug Topics

Amina Abubakar, PharmD, AAHIVP, joined Drug Topics to discuss her career journey as an independent pharmacy owner and the ways in which she’s been able to grow her business.

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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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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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Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, Highlights Key Reasons to Attend OPC 2025

Pharmacy Times

Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, co-chair of the 2025 Oncology Pharmacists Connect (OPC) meeting, discusses what makes the event unique, highlights key sessions, and shares her excitement for the educational and networking opportunities.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results

STAT

Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of them suffered severe bouts of low blood sugar. After 12 months, out of the 12 participants, 10 no longer needed to inject insulin.

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FDA approves Widaplik for hypertension

The Checkup by Singlecare

The U.S. Food and Drug Administration (FDA) has approved Widaplik, a new triple combination medication designed to treat high blood pressure in adults. Widaplik is the first single pill containing three different drugs approved as an initial treatment for hypertension. It’s a huge win for people who would otherwise likely need several different prescriptions to optimize their cardiovascular health.

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FDA blocks trials that send US cells to 'hostile' countries

pharmaphorum

The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as leadership at the agency in this area is sidelined.

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AI Generated Marketing Campaigns: Is Pharma Ready?

Pharma Marketing Network

The intersection of artificial intelligence and pharmaceutical marketing is creating new waves of innovation. In 2025, AI generated marketing campaigns are no longer experimental. They are being deployed to personalize content, predict engagement, and automate outreach. But is the pharma industry truly ready to embrace these capabilities? Table of Contents What Are AI Generated Marketing Campaigns?

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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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CDC workers fired from prominent STI, hepatitis labs are rehired

STAT

The staff of two world-class laboratories at the Centers for Disease Control and Prevention that were slated to be closed in a round of cuts announced in April have been informed that their terminations have been canceled. The CDC’s sexually transmitted disease laboratory and its viral hepatitis laboratory were targets of layoffs initiated by the U.S.

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CVS Under Investigation for Text Messages Lobbying Against Louisiana PBM Reform

Drug Topics

Louisiana opened the investigation upon discovering a CVS text message campaign sent out to patients asking them to advocate against proposed legislation.

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Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

Pharmacy Times

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Gilead's twice-yearly PrEP drug is cleared by FDA

pharmaphorum

Gilead has FDA approval for a twice-yearly PrEP drug, but could proposed cuts to US funding for HIV prevention programmes hinder its take-up?

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Changing the PAP Model

Pharmaceutical Commerce

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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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At-Home Testing Offers Unique Opportunities for Community Pharmacies

Drug Topics

At the Total Pharmacy Solutions Summit Spring 2025 event, diagnostics experts Jenna Anderson and Amanda Wiley explored community pharmacists’ role in at-home testing.

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ASCO 2025: Real-World Outcomes of Frontline ICI Therapy in BRAF-Mutated Melanoma in the Community Setting

Pharmacy Times

Janet Espirito, PharmD, discusses real-world outcomes from a large community oncology study showing that patients with BRAF-mutated melanoma—including those with brain metastases—experienced similar benefit from frontline immune checkpoint inhibitor (ICI) therapy.

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Grail plans FDA filing for cancer blood test after new trial

pharmaphorum

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Social Media Strategies in Pharma for the Second Half of 2025

Pharma Marketing Network

In 2025, the landscape of healthcare marketing is evolving faster than ever—and nowhere is this more evident than on social media. As patients, providers, and pharmaceutical brands increasingly interact online, “Social Media Strategies” have become mission-critical for staying relevant and compliant. But how can pharma marketers leverage these channels effectively in the second half of the year?

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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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Mark Cuban Cost Plus Drugs, 9amHealth Collaborate to Make Obesity Medications Affordable

Drug Topics

News FDA Updates Law and Advocacy Technology Trends Viewpoints All News Media In-Depth Insights Pharmacist View Script-Ed Expert Interviews Podcasts Conferences Conference Coverage Conference Listing Resources Disease Awareness White Board Video American Pharmacists Month Sponsored Resources CME/CE Partners Publications Drug Topics Journal Total Pharmacy Journal Submission of Articles Events Virtual Events Total Pharmacy Solutions Summit Business Business Strategies Patient Services Pharmacy Inv

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Tom Kraus on Top Advocacy Priorities for Pharmacists: 340B Protections, Payment Reform, and Grassroots Action

Pharmacy Times

From protecting the 340B Drug Pricing Program to expanding payment pathways through state-level reforms and Medicare Advantage opportunities, Kraus emphasized the critical role pharmacists play in evolving care models.

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FDA unveils fast-track review path for 'national priorities'

pharmaphorum

FDA Commissioner Marty Makary has revealed a new priority review voucher programme for new medicines deemed to be of national priority for the US

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The Case for Pharmacy Automation

DiversifyRx

Running an independent pharmacy means balancing inventory, staff, compliance, and patient care—all at once. Pharmacy automation offers a powerful solution: save time, boost accuracy, enhance efficiency, and elevate patient care—without having to hire a bunch of staff. Technology can truly transform your pharmacy. Here’s how to integrate pharmacy automation into your operations.