May, 2025

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Opinion: I’m a dentist from India. The fluoride debate in the U.S. horrifies me

STAT

Florida has just banned fluoride in public water , becoming the second state to do so. It’s part of decadeslong battle that has heated up in recent years. Local governments debate whether it belongs in the water supply. Parents question safety. Pseudoscience clouds public perception. Often, the conversation is framed as a domestic ideological battle between personal liberty and public health mandates.

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A new CFO tasked with taking ‘scrappy’ Editas from last year’s layoffs into new gene editing territory

PharmaVoice

Amy Parison, who stepped into the lead financial role at the company in March, is managing Editas Medicine’s transition to a new gene editing platform while recovering from a major overhaul.

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AviadoBio opens UK trial for FTD gene therapy

Pharma Times

Aspire-FTD study aims to stop disease progression with one-time treatment

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7 common compliance issues faced by the pharmaceutical industry in India

Express Pharma

Indias pharmaceutical industry is one of the largest in the world, playing a crucial role in both domestic healthcare and global drug supply. But behind the innovation and scale lies a web of regulations that pharma companies must follow closely. Compliance in this sector is non-negotiable; it impacts everything from manufacturing and labour to environmental practices and global trade.

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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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A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases

BioPharma Dive

A gene editing drug custom-made for a critically ill baby showed that, for some ultra-rare diseases, it’s possible to design and test a new CRISPR medicine in just a few months.

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More Trending

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New FDA framework on Covid vaccines leaves pediatricians confused and concerned

STAT

A new framework for Covid-19 vaccines announced by Food and Drug Administration leaders Tuesday suggests the agency will no longer approve new Covid vaccines for healthy individuals under 65, including babies, without data from new randomized clinical trials showing their benefit.  The plan — described in a commentary in the New England Journal of Medicine, followed by a live stream on YouTube — created confusion among physicians about what it means for young children.

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A startup with Theranos ties has another blood test in the works. This time, competition is waiting.

PharmaVoice

A stealth startup built by the partner of disgraced Theranos founder Elizabeth Holmes is taking a shot at a new blood test — an area where other companies are already making strides.

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Sanofi and CD&R finalise Opella deal, launching global consumer healthcare giant

Pharmafile

Sanofi and Clayton, Dubilier & Rice (CD&R) have officially closed the sale of a controlling 50% stake in Opella, Sanofis consumer healthcare division, positioning Opella as a new independent leader in the global consumer health space. The deal brings Sanofi approximately 10bn in net cash proceeds. Sanofi retains a 48.2% share in Opella, with Bpifrance […] The post Sanofi and CD&R finalise Opella deal, launching global consumer healthcare giant appeared first on Pharmafile.

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The Commissioner’s Magical Mystery Tour: Many Questions About this Unique Opportunity

FDA Law Blog: Biosimilars

By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. These are scheduled to take place in several cities on both coasts in June and July (Link here). This tour to engage with pharmaceutical and biotech CEOs is unprecedented. According to the announcement, Commissioner Makary will be holding these along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDAs Center for Biologics Evaluation a

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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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Merck, Daiichi pull approval application for ADC in lung cancer

BioPharma Dive

A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.

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New technology could enhance CAR T therapy manufacture

European Pharmaceutical Review

Research has illustrated a potential new device for harvesting T cells that could improve the cost-effectiveness of manufacturing CAR T-cell therapy and make the cancer immunotherapy more accessible to patients. In development by investigators in the US, the device, called capture and glow (CAPGLO), captures T cells via a magnetic field and makes them visible using glowing fluorescent tags.

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STAT+: With Covid vaccine decisions, RFK Jr. unleashes an unfettered assault on public health  

STAT

Robert F. Kennedy Jr.’s unilateral decision that the Centers for Disease Control and Prevention would no longer recommend Covid-19 boosters for healthy people during childhood or pregnancy represents a bulldozing of safeguards intended to keep public health officials honest and their decisions transparent. It also tramples on individuals’ ability to make their own decisions about medical evidence.

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With the third round of Medicare price negotiations on the way, here’s how the policy is shifting

PharmaVoice

HHS issued guidance for the third cycle, teeing up another 15 drugs to be selected by early next year.

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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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Accretion Pharmaceuticals’ IPO to open on May 14 2025; Price band fixed at ₹96-101

Express Pharma

Accretion Pharmaceuticals, an Ahmedabad-headquartered pharmaceuticals manufacturer, announced that its initial public offering (IPO) will open for subscription on Wednesday, May 14, 2025. The anchor portion will be opened on Tuesday, May 13, 2025, and the issue will conclude on Friday, May 16, 2025. The company intends to raise 29.75 crore from the offering and aims to be listed on the NSE Emerge platform.

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FDA tightens heart tox warnings on mRNA COVID vaccines

pharmaphorum

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity

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FDA sets stricter approval standards for COVID vaccines

BioPharma Dive

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

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FDA awards cancer drug approvals to AbbVie and MSD

Pharmaceutical Technology

The FDA has approved MSDs Welireg for rare adrenal tumours, and AbbVies Emrelis for treating c-Met+ lung cancer patients.

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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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Sedative ‘dex’ is replacing ‘tranq’ in illegal drug supply and causing excruciating withdrawal

STAT

The era of “tranq” may be ending. But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.

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Is pharma ready to let go of animal testing?

PharmaVoice

Regulators have signaled their willingness to embrace alternative tests and guide the industry in new directions.

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Ten tips for providing effective diabetes reviews

The Pharmacist

PCN pharmacy lead Gareth Malson offers his top ten tips for supporting people with diabetes to improve control of their condition at regular review The prevalence of diabetes is continuing to rise at an alarming rate. In 2023-24, the national diabetes register increased by around 21 people every hour, with 4.6m living with diabetes in […] The post Ten tips for providing effective diabetes reviews appeared first on The Pharmacist.

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InflaRx stock halves after it drops lead drug

pharmaphorum

InflaRx has abandoned its drug development programme, vilobelimab for rare skin disease pyoderma gangrenosum, cratering its share price.

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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 delays approval decision for Biohaven rare disease drug

BioPharma Dive

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.

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How to Create a Robust Generic Drug Quality Management System

Drug Patent Watch

"Generic Medications: The Unseen Struggle for Quality Control As the pharmaceutical industry grapples with the complexities of generic drug production, a hidden crisis is unfolding. Despite their lower price points, generic medications often fall short of their branded counterparts in terms of quality and consistency. But what if I told you there's a way to bridge this gap?

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Opinion: I was a Theranos whistleblower. Here’s what I think Elizabeth Holmes is up to

STAT

I always knew Elizabeth Holmes would have a second act. But I’m shocked it’s starting while she’s still behind bars. Elizabeth is now serving an 11-year sentence for defrauding investors in Theranos and has been banned from participating in federal health programs. The company was built on her claim that, at 19 years old, she had invented a device capable of running hundreds of tests from just a single drop of blood.

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With TV ads under threat, here’s how pharma can leverage social media

PharmaVoice

RFK Jr.’s plan to ban TV advertising may shift more marketing attention to online platforms.

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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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How PCN pharmacists led a hypertension outreach event

The Pharmacist

Wandle PCN collaborated with the Central London Community Healthcare NHS Trust (CLCH) to launch a pharmacist-led initiative to tackle hypertension. The collaboration saw a group of pharmacists organise a hypertension event, targeting high-risk individuals who did not engage with primary care for health checks. CLCH senior clinical pharmacist Upriya Patel explains more.

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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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Prasad’s FDA appointment pressures cell and gene therapy stocks

BioPharma Dive

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.

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