Wed.May 07, 2025

article thumbnail

SK Pharmteco Debuts New cGMP Plasmid Suite

Pharmaceutical Commerce

The move bolsters the CDMOs commitment to cell and gene therapy by incorporating advanced manufacturing and fill-finish capabilities.

52
article thumbnail

FDA Grants Ustekinumab-Aekn Interchangeability Designation for Stelara

Drug Topics

Selarsdi is interchangeable for all indications of ustekinumab, including treatment of psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

FDA 527
Insiders

Sign Up for our Newsletter

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

article thumbnail

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.

182
182
article thumbnail

Scripted for Her: Helping Patients Choose Contraceptive Methods

Drug Topics

In this episode of the podcast, Natalie DiPietro Mager, PharmD, PhD, sits down with Jasmine Cutler, PharmD, CPh.

343
343
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

Opinion: ‘It’s not too late to do something about this’: An open letter from a leading vaccine advocate to Sen. Cassidy about RFK Jr.

STAT

Robert F. Kennedy Jr. holds his anti-vaccine beliefs with the strength of a religious conviction, writes rotavirus vaccine co-inventor Paul A. Offit.

Vaccines 145
article thumbnail

Calories to Satiation Predicts Patients Likely to Experience Adverse Events From GLP-1s

Drug Topics

Patients often have anxiety about potential adverse effects, and experiencing adverse effects can affect patient adherence.

316
316

More Trending

article thumbnail

How AI Can Improve the Pharmacist’s Workload | NCPDP 2025

Drug Topics

Stanley V. Campbell, Jr., CEO of EagleForce Associates, Inc., and Yi Deng, PhD, Senior Vice President of Engineering at EagleForce, explore real-world examples of AI giving time back to pharmacists.

309
309
article thumbnail

STAT+: New CBER Director Vinay Prasad praises evidence, FDA reviewers in first speech to staff

STAT

WASHINGTON — In his first address to FDA staff on Wednesday, Vinay Prasad emphasized his commitment to evidence, his admiration for agency employees, and his desire to serve the American public.  The new director of the Center for Biologics Evaluation and Research sounded very different from his online firebrand persona. He struck a humble, self-deprecating, and even earnest tone, calling the American people the agency’s “number one stakeholder.

FDA 142
article thumbnail

AI’s Ability to Directly Impact Patient Outcomes | NCPDP 2025

Drug Topics

Stanley V. Campbell, Jr., CEO of EagleForce Associates, Inc., and Yi Deng, PhD, Senior Vice President of Engineering at EagleForce, discuss how AI is being used to benefit patients.

282
282
article thumbnail

Tariffs on medicines would harm American competitiveness, industry and patients

PhRMA

PhRMA submitted comments to the U.S. Department of Commerce on its Section 232 investigation of pharmaceuticals and pharmaceutical ingredients imported to the United States.

130
130
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

Bemnifosbuvir, Ruzasvir Regimen Shows Strong Efficacy as HCV Treatment

Drug Topics

A phase 2 study found 95% of patients achieved a sustained virologic response at 12 weeks regardless of treatment adherence.

247
247
article thumbnail

Prasad’s FDA appointment pressures cell and gene therapy stocks

PharmaVoice

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

FDA 130
article thumbnail

Optimizing Workflow and Staff Training for Point-of-Care Testing Implementation

Drug Topics

A panelist discusses how transforming pharmacy staff roles by training technicians to handle clinical programs such as point-of-care testing creates a more efficient workflow system, similar to how physicians work with nurses.

247
247
article thumbnail

STAT+: Vinay Prasad is outraged, and now at the FDA. How will biotech deal?

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. “Just when I thought I was out, they pull me back in.” — Michael Corleone, “Godfather Part III.”  I had this thought Monday while out for a walk with Bo: I’m going to write an entirely politics-free newsletter this week.

FDA 129
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

Medical Billing Strategies for Point-of-Care Testing in Community Pharmacy

Drug Topics

A panelist discusses how medical billing for point-of-care testing represents a significant revenue opportunity for pharmacies. Further, though the process will be initially unfamiliar, pharmacists should learn and control it rather than outsourcing it.

article thumbnail

Cancer innovation in ‘era of fear’: New AI tools meet old access barriers — and new funding cuts

STAT

Innovation in cancer detection, treatment, and prevention is stirring excitement today, accelerated by advances in artificial intelligence and other technological tools wielded by scientists, physicians, and even patients. Still, serious gaps remain between theory and reality, experts said Tuesday. There’s a gap in access. There’s a gap between clinical guidance and clinical practice.

121
121
article thumbnail

UK trumpets a trade deal with India - but pharma isn't happy

pharmaphorum

Various industries have welcomed news of a trade deal between the UK and India, but Britain's pharma sector isn't among them

101
101
article thumbnail

STAT+: Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list

STAT

A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from a shortages list kept by the agency. The move means that patients will no longer have access to cheaper versions from compounding pharmacies.

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

IVIG Can Cause Kidney Function Decline, Thromboembolism in Patients With Dermatological Conditions

Pharmacy Times

Intravenous immunoglobulin (IVIG) treatment for dermatologic conditions shows effectiveness but poses risks of kidney decline and thromboembolism, necessitating careful monitoring.

94
article thumbnail

STAT+: The state of antibiotic development: ‘Deplorable comes to mind’

STAT

Four years ago, an ambitious pharmaceutical industry venture to tackle antibiotic resistance launched to acquire or invest in small companies that can develop two to four novel antibiotics by 2030 — and replenish the global supply chain with needed treatments. The effort began with $1 billion in backing from several large drugmakers, the European Investment Bank and Wellcome Trust.

118
118
article thumbnail

Solve FSHD to invest in Armatus Bio for ARM-201 development

Pharmaceutical Technology

Venture philanthropy organisation Solve FSHD has announced an investment of $3m in Armatus Bio to support the development of ARM-201.

93
article thumbnail

STAT+: Marea drug cuts type of blood fat in half in study

STAT

Marea Therapeutics said Wednesday that an experimental drug reduced by half a type of blood fat called remnant cholesterol — a mid-stage study result that paves the way for further trials and could lead to a new way of treating cardiovascular disease.  Remnant cholesterol is distinct from LDL (bad) or HDL (good) cholesterol, and elevated levels are associated with a higher risk of serious cardiovascular events even in patients prescribed standard cholesterol-lowering medicines, said

114
114
article thumbnail

UPMC's Innovative Approach to Heart Failure Care: Collaboration and Patient/Member-Centered Care Management

Pharmacy Times

UPMC enhances care for patients with heart failure through integrated pharmacy and cardiology team collaboration.

89
article thumbnail

Opinion: The doctor is in. So is their AI

STAT

No one goes to medical school because they want to type quickly while listening to patients talk. But that’s what practicing medicine means for many today: fingers flying over the keyboard to log data. Later, they will use that information to create a note for the patient’s file. Technology now offers a solution to this problem in the form of the AI ambient scribe, which records the encounter between physician and patient and then generates the summarizing note for the patient

article thumbnail

Low-Dose Chlorthalidone Granted FDA Approval for Treatment of Adults With Hypertension

Pharmacy Times

The 12.5-mg dose tablet enhances hypertension treatment options and reduces adverse effects for patients.

FDA 86
article thumbnail

Biotech stocks fall on Vinay Prasad news

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Biotech was not faring well yesterday, after we got the news that Vinay Prasad was chosen to be the next director of the FDA’s biologics center.

FDA 110
article thumbnail

Fierce Healthcare - Untitled Article

Fierce Healthcare

CMS is notifying insurers Congress may appropriate money toward cost-sharing reduction payments, causing upheaval in the Affordable Care Act market,

article thumbnail

STAT+: How well do ‘AI scientists’ actually work? I tested one.

STAT

Y ou’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine.  Sign up to get it  delivered in your inbox every Wednesday.   I love trying the local ice cream when I visit a different city. I recently had the best ice cream experience of my life at Woodside Farm Creamery near Wilmington, Delaware — they sell their ice cream cones/bowls by the ounce and have great, funky

108
108
article thumbnail

Fierce Healthcare - Untitled Article

Fierce Healthcare

Oscar Health's stock increased by 30% after its first quarter earnings, but company executives weighed in on the potential adverse consequences of cost-sharing reductions, ACA enhanced subsidy expirations and a shortened enrollment window.

85
article thumbnail

Women’s Health Initiative gets official word on funding

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning, and happy Wednesday. I’m seeing Japanese Breakfast perform in Boston tonight. (Michelle Zauner, the band’s frontwoman, is actually Korean-American, not Japanese. I highly recommend her memoir, “Crying in H Mart.

99
article thumbnail

New data could move Enhertu into early breast cancer

pharmaphorum

AstraZeneca and Daiichi Sankyo's Enhertu has been shown to provide a benefit in a phase 3 trial in early-stage breast cancer for the first time

82
article thumbnail

STAT+: Flatiron Health veterans raise $25 million for AI tool to forecast drug toxicity

STAT

In January, San Francisco’s Union Square was bustling with hordes of drug developers and investors, pounding the pavement on their way from meeting to meeting. But Rohan Ganesh, an investor at the VC firm Obvious Ventures, wasn’t among them. He only agreed to hear one company’s pitch during this year’s J.P. Morgan Healthcare Conference.

97
article thumbnail

Fierce Healthcare - Untitled Article

Fierce Healthcare

The university and its affiliated hospitals have now paid out over $1 billion to hundreds of former patients of Robert Hadden, who hasn't practiced since 2012 and was convicted and sentenced in 2023.