Fri.May 09, 2025

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First at-home test kit for cervical cancer approved by the FDA, company says

STAT

WASHINGTON — U.S. regulators have approved the first  cervical cancer  testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company. Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer.

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GSK reveals data behind linerixibat for PBC 'relentless itch'

pharmaphorum

GSK reveals the data behind its linerixibat for itching associated with autoimmune liver disease PBC as it anticipates first approvals for the drug.

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Trending Sources

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Opinion: Requiring a four-year emergency medicine residency is a terrible idea

STAT

Less than two years ago, I completed a three-year emergency medicine residency and, after passing written and oral board exams, became a board-certified emergency physician. Now, the Accreditation Council for Graduate Medical Education is claiming that three years of personal and financial sacrifice are not enough.  The ACGME reviews each specialty’s program requirements every 10 years, and it recently released their proposed updates for emergency medicine.

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Secrets of Pharmaceutical Market Access

Pharma Marketing Network

What does it take to bring a life-saving therapy to market and ensure patients can actually access it? Behind every successful drug launch lies a labyrinth of negotiations, pricing models, and payer strategies. Understanding the pharmaceutical market access process is crucialnot only for commercialization teams but for marketers and strategists looking to position their brands competitively.

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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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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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More Trending

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Risk factors for childhood high blood pressure

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. I had planned to make this box about a recent study that confirmed some birds form friendships. But as a lapsed Catholic who spends too much of her time watching college basketball (shout-out Xavier University), I am *thrilled* that we’re getting a pope who seemingly knows ball.

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Pharma still in waiting mode after UK-US trade agreement

pharmaphorum

Hopes that the UK-US trade agreement would give some clarity on the situation for pharmaceuticals proved optimistic.

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FDA approves Verastem’s ovarian cancer treatment

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, we talk about the FDA’s new artificial intelligence effort in the wake of mass layoffs, see AI darling Insitro cut staff, and more.

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Vor Bio winding down as multiple biotechs downsize

pharmaphorum

Biotech pressures exposed as big job losses are announced at Vor Bio, IGM Biosciences, Rallybio, Insitro, and Korro Bio.

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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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Innovative CAR T therapy could deliver in broader therapeutic settings, research suggests

European Pharmaceutical Review

A next-generation CAR T cell therapy has shown promise for treatment-resistant B-cell lymphoma, new research shows. Results from the Phase I clinical trial found that the treatment reduced cancer in 81 percent of patients, and enabled complete remission in 52 percent of patients. These findings are notable, because over half of lymphoma patients given currently available CAR T therapies, a form of personalised immunotherapy, do not experience long-term remission, the researchers explained.

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AZ plots wider Imfinzi use in bladder cancer after trial win

pharmaphorum

AstraZeneca's run of positive trial results with its cancer therapies has continued with a win for its immunotherapy Imfinzi in early bladder cancer

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GLP-1 Drug Repurposing for Addiction Disorders Hampered by High Costs and Legal Hurdles

PharmExec

Armando Castro, partner, emerging companies, venture capital, Lowenstein Sandler, explains how regulatory, patent, and reimbursement challenges are slowing venture investment in GLP-1 and psychedelic addiction therapies.

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The value of a partner, globally and locally

pharmaphorum

With the FDA and EMA releasing their annual reports detailing novel drug approvals in 2024, a new pharmaphorum podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face in the year ahead.

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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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Is the Industry Ready for the DSCSA?

Pharmaceutical Commerce

In the second part of his Pharma Commerce video interview, Michael Rowe, Two Labs senior director of DSCSA/serialization compliance services, comments on stakeholders overall preparedness for complying with the latest enforcement deadlines.

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Gilead’s Livdelzi Shows Lasting Efficacy in Primary Biliary Cholangitis, Regardless of Prior Therapy

PharmExec

Interim results from the ongoing Phase III ASSURE trial demonstrated that Livdelzi maintained a consistent biochemical response in patients with primary biliary cholangitis.

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Galimedix completes key stage of clinical trial for treatment targeting eye and brain diseases

Pharmafile

Clinical biotech, Galimedix Therapeutics, has announced the completion of a single ascending dose (SAD) part of a phase 1 study of GAL-101, a novel therapy aimed to treat serious neurodegenerative eye and brain conditions. The SAD study showed that GAL-101 was well-tolerated and has a strong safety and pharmacokinetic profile. These promising results have allowed […] The post Galimedix completes key stage of clinical trial for treatment targeting eye and brain diseases appeared first on Ph

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FDA Approves Teal Wand, First At-Home Self-Collection Cervical Cancer Screening Device

Pharmacy Times

The new at-home test aims to increase comfort and screening timeliness through a more accessible method.

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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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Measuring What Matters

Pharmaceutical Commerce

Ways to reimagine pharmas operating model and KPIs for commercial success in an AI-driven future.

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Biosimilars: Unlocking access, closing the cost divide

pharmaphorum

Cost-related nonadherence (CRN) the act of skipping doses, splitting pills, or delaying refills to save money is a major issue among US adults with chronic conditions.

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HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines

Pharmaceutical Technology

HLS Therapeutics has signed an agreement with Esperion Therapeutics for commercialising Nexletol and Nexlizet in Canada.

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Pharma Pulse 5/9/2025: Teva Plots Thousands of Job Cuts as Restructuring Drive Enters 'Acceleration' Phase, Takeda to Invest $30B Into US Operations

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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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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FDA chief Martin Makary sets June deadline for genAI rollout

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has set an "aggressive" timeline to implement genAI across the agency by 30 June 2025.

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Healthcare Advertising That Works: Data-Driven Pharma Campaigns That Convert

Pharma Marketing Network

Is your healthcare advertising generating the conversions your pharma brand needs? In todays competitive, digitally saturated market, traditional messaging no longer cuts it. Precision targeting, performance insights, and adaptive content are essential to reach both healthcare professionals (HCPs) and patients effectively. Fortunately, the rise of data-driven strategies is helping marketers build more intelligent campaigns that truly convert.

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FDA Grants Accelerated Approval to Verastem Oncology’s Avmapki Fakzynja Co-Pack for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

PharmExec

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

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Apiary invests in life sciences SEO pioneer PIO to support global expansion

Pharmafile

Private equity firm Apiary Capital has invested in performance-io (PIO), a specialist life sciences performance marketing and SEO agency, to accelerate its international growth and service expansion. Founded in London in 2018, PIO was the first SEO agency to serve highly regulated pharma and biotech markets. The company helps clients leverage upcoming technologies, especially artificial […] The post Apiary invests in life sciences SEO pioneer PIO to support global expansion appeared first

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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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Bavarian Nordic shares rise 7% following strong Q1 for vaccine sales

Pharmaceutical Technology

Bavarian Nordic is successfully navigating a sentiment-changing vaccine landscape, posting Q1 revenues significantly up from Q1 2024.

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Live Zoster Vaccine May Reduce Risk of Cardiovascular Events by 23%, Study Finds

Pharmacy Times

The most substantial reduction was achieved 2 to 3 years after vaccination with a sustained protective effect lasting up to 8 years

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Haya secures $65m in Series A funds to advance heart failure treatment

Pharmaceutical Technology

Haya Therapeutics has secured $65m in Series A funding to expedite the clinical development of HTX-001 for treating heart failure.

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