April, 2025

article thumbnail

FDA Grants Fast Track Designation for Potential Bird Flu Vaccine

Drug Topics

The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.

Vaccines 691
article thumbnail

CDC division responsible for asthma control and lead poisoning prevention effectively eliminated

STAT

After Hurricane Ian, as Floridians returned home to sodden furniture and moldy piles of debris, many with asthma could feel their chests tightening. To figure out what was safe, some sent their concerns directly to the U.S. Centers for Disease Control and Prevention.  But on Tuesday — days before floods ravaged Nashville, potentially prompting similar queries — the people who would normally answer such asthma questions stopped working.

145
145
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t

FDA 144
article thumbnail

Genetic breakthroughs could point pharma to a long COVID drug

PharmaVoice

The discoveries also hold potential benefits for patients with other conditions, such as chronic fatigue syndrome.

342
342
article thumbnail

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

article thumbnail

How the IRA is impacting the generic drug market

PhRMA

For more than four decades since the passage of the Hatch-Waxman Act, the U.S. generic drug market has provided patients with low-cost alternatives to brand-name medicines, saving the health care system billions while preserving incentives for biopharmaceutical innovation. Today, low-cost generics account for nine out of every 10 prescriptions dispensed in the United States and come with an average copay of about six dollars.

130
130
article thumbnail

FDA approves novel therapy for chronic skin condition

European Pharmaceutical Review

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Sanofi and Regeneron Pharmaceuticals collaborated to develop Dupixent (dupilumab). Under the FDA’s new authorisation, the therapy is indicated for individuals aged 12 years and over with the chronic inflammatory skin disease, who still experience symptoms despite taking histamine-1 (H1) antihistamine medication.

FDA 105

More Trending

article thumbnail

HHS cuts leave future of mental health, substance use hotlines uncertain

STAT

Hotlines that have fielded millions of calls from people — including new mothers — looking for mental health support or to quit smoking are in limbo after federal officials fired the workers who oversaw them.  Employees were cut from offices that fund prevention work on the local, state, and tribal level. Those include hotlines like the Maternal Mental Health Hotline run by the Health Resources and Services Administration, and another to help smokers quit using tobacco.

143
143
article thumbnail

West Middlesex Hospital goes live with tech to reduce prescribing errors

Pharmafile

Dosium Touchdose has gone live at West Middlesex University Hospital, UK, a clinical decision support technology proven to significantly reduce prescribing errors. This follows go-live at both Chelsea and Westminster Hospital last month, and St Marys Hospital last summer, marking the final stage of rollout across the entire West London Childrens Healthcare (WLCH) partnership.

article thumbnail

Is the FDA ‘finished’? Leadership drain hits agency hard.

PharmaVoice

Amid widespread staff reductions at health agencies, a number of key officials have bid farewell to pharma’s top regulator.

FDA 312
article thumbnail

Mounjaro generic availability, cost, and more

The Checkup by Singlecare

Many people are interested in generic drug availability since brand-name drugs are often costly. Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. It is also commonly used off-label for weight loss because, as a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide helps control appetite

article thumbnail

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.

article thumbnail

NICE recommends new combination breast cancer drug

European Pharmaceutical Review

The National Institute For Health and Care Excellence ( NICE )s has recommended a new combination treatment for advanced breast cancer patients. AstraZenecas Truqap (capivasertib) in combination with fulvestrant is indicated as a treatment option for around 1,100 UK adults with hormone receptor (HR)-positive HER2-negative breast cancer with certain genetic mutations.

article thumbnail

The 3 Types of PBM Reform Aiming to Change the Pharmaceutical Market

Drug Topics

Antonio Ciaccia, President of 3 Axis Advisors, CEO of 46brooklyn Research, and pharmacy benefits expert, discusses litigious, market-based, and legislative reform for pharmacy benefit managers.

621
621
article thumbnail

STAT+: With the FDA in turmoil, the ‘revolving door’ with industry is spinning faster

STAT

Health and Human Services Secretary Robert F. Kennedy Jr. has railed against what he sees as a “revolving door” between workers at drug companies and the Food and Drug Administration. But his department’s actions now seem to be causing that door to spin ever faster.  Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry re

FDA 133
article thumbnail

Analysis Finds Children Have Elevated Kidney, Heart Risks Years After COVID-19 Infection

Pharmacy Times

Research reveals that children face significant long-term health risks, including kidney, gastrointestinal, and cardiovascular issues, after COVID-19 infection.

168
168
article thumbnail

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.

article thumbnail

A big moment is coming for psychedelics

PharmaVoice

Compass Pathways expects to publish the first phase 3 results from a large-scale, psilocybin drug trial by the end of this quarter.

275
275
article thumbnail

Does Aetna cover Ozempic?

The Checkup by Singlecare

People with Type 2 Diabetes have many treatment options these days, though not all are covered by insurance. Ozempic is a prescription weekly injection manufactured by Novo Nordisk. It is often covered by insurance when prescribed for diabetes (not weight loss ). However, not all insurance plans cover Ozempic and when it is covered, the coverage amount may vary by provider and plan.

article thumbnail

Prioritise cultural change to enhance pharma digital innovation efforts, says Pistoia Alliance

European Pharmaceutical Review

New findings from The Pistoia Alliance report major challenges to adoption of data-driven innovation and AI in life sciences. The research is based on a poll conducted at the organisations annual European conference. Resistance to change emerged as the biggest obstacle to innovation (51 percent). To overcome this, the Alliance urged the pharmaceutical industry to prioritise cultural and behavioural change in digital transformation efforts.

64
article thumbnail

PBM Reform Delays Continue to Negatively Impact Pharmacies | AAP 2025

Drug Topics

A conversation with Douglas Hoey, CEO of the National Community Pharmacists Association, at the American Associated Pharmacies 2025 Annual Conference.

624
624
article thumbnail

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.

article thumbnail

Public health leaders, distrustful of RFK Jr., stand up project to defend vaccines 

STAT

Some key public health figures are taking an extraordinary step to try to shore up U.S. vaccination policy, feared to be under threat from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic. The “Vaccine Integrity Project,” which was publicly launched Thursday by the University of Minnesota’s Center for Infectious Disease Research and Policy, will be aimed at assessing the best ways for vaccine proponents to safeguard vaccination policy and

Vaccines 138
article thumbnail

The biopharmaceutical industry is one of the highest contributors to America’s economy among all manufacturers

PhRMA

America’s biopharmaceutical companies are committed to revitalizing American manufacturing, and they continue expanding their U.S. footprint. Supporting nearly five million jobs and more than 1,500 facilities across the U.S., we’re making investments that help develop new treatments and cures and contribute to America’s economy.

167
167
article thumbnail

US backlash against mRNA vaccines could hinder scientific progress

PharmaVoice

U.S. health agencies are taking the fight to vaccine and mRNA research, which could have lasting repercussions on medical and scientific advancements.

Vaccines 246
article thumbnail

Philippe Masset appointed to Vect-Horus board of directors

Pharmafile

Vect-Horus has announced the appointment of Philippe Masset to the companys board of directors. This contributes to a series of senior leadership appointments which are strategic for Vect-Horus growth. Masset is a senior banking executive with a wealth of experience in investment banking, environmental, social and governance (ESG) topics, sustainable finance, and AI.

76
article thumbnail

From pipettes to processors: How AI Is reshaping pharma’s future

European Pharmaceutical Review

Over the past decade, we have witnessed the arrival of a new era in biopharmaceutical R&D. Traditional methods and processes, such as wet labs, are being augmented by a rapidly expanding digital ecosystem in pharma. Across the industry, this shift is offering extraordinary opportunities to increase the speed, accuracy, and reproducibility of research.

76
article thumbnail

GLP-1 Medications Continue to Increase Market Growth | Asembia 2025

Drug Topics

Glucagon-like peptide-1 medications are the fastest-growing class of medication and will continue to be prevalent as more indications, such as sleep apnea, are added.

544
544
article thumbnail

HHS starts layoffs of thousands of workers across its agencies

STAT

Layoff notices began arriving early Tuesday for thousands of employees of the sprawling Department of Health and Human Services and its subsidiary agencies, with as many 10,000 workers potentially expected to be hit by the cuts. “I regret to inform you that you have been affected by a reduction in force (RIF) action,” an email to affected employees said.

FDA 145
article thumbnail

Marketing in Pharma: Strategies that work in 2025

Pharma Marketing Network

Introduction If the past few years have taught pharma marketers anything, it’s that agility, data, and digital-first thinking aren’t just buzzwordsthey’re survival tactics. Marketing in pharma has undergone a radical shift, propelled by digital transformation, patient-centric demands, and evolving regulatory landscapes. In 2025, the strategies that succeed are rooted in personalization, innovation, and real-time adaptability.

article thumbnail

Pharma’s manufacturing moment: Where companies are making the biggest moves

PharmaVoice

The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.

259
259
article thumbnail

Study: Vitamin B12 Levels Within "Normal" Range Linked to Cognitive Decline in Older Adults

Pharmacy Times

Current recommended levels of vitamin B12 might not be sufficient to protect against neurological decline.

175
175
article thumbnail

The key role of GMP analytical testing for drug products

European Pharmaceutical Review

Analytical testing is an essential part of guaranteeing the quality, safety and effectiveness of pharmaceutical products. However, the process is not without its challenges and it requires a proactive approach if both compliance and efficiency are to be maintained. This is why it is essential to develop and validate analytical methods to support activities and functions such as process validation controls, stability tests and dissolution profiles.

Dosage 64
article thumbnail

National Association of Attorneys General Urges Congress to Prohibit PBM-Owned Pharmacies

Drug Topics

On behalf of 39 state and territory attorneys general, the National Association of Attorneys General issued a letter to Congress regarding major PBMs conflicts of interest.

560
560
article thumbnail

Opinion: Dismantling the one U.S. agency focused on older adults, people with disabilities is startlingly inefficient

STAT

Even before the Department of Health and Human Services announced its recent major reorganization, the media had been reporting on anticipated changes to the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health. But the very last bullet on the HHS fact sheet was a complete surprise to most people: the elimination of the Administration for Community Living (ACL).

145
145
article thumbnail

More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals

The FDA Law Blog

By Dr. Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA staff were missing minor deadlines.

FDA 77
article thumbnail

What’s being cut at NIH

PharmaVoice

A look at the government’s far-reaching rollback in research grants so far.

245
245