Trending Articles

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Medication Optimization Needed for Patients with Long COVID

Drug Topics

Investigators said there is an imperative to optimize medication utilization and explore the consequences of medication burden on treatment outcomes in patients with long COVID.

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Opinion: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Smart ring maker Oura picks up $75M series D, inks strategic partnership with Dexcom

Fierce Healthcare

Oura is partnering with medical device maker Dexcom to integrate data from glucose biosensors with the Oura Ring, which tracks sleep, heart rate and activity. | Oura is partnering with medical device maker Dexcom to integrate data from glucose biosensors with the Oura Ring.

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FDA Grants Rare Pediatric Disease Designation for Treatment of Neonatal SP-B Deficiency

Pharmacy Times

The disorder presents as severe lung disease, with lung transplantation as the only current therapeutic option for long-term survival.

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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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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Specialty Pharmacist Transforms HIV Care Outside of the Pharmacy

Drug Topics

Cassandra Esperant, PharmD, AAHIVP, discussed the ups and downs of her career journey as a clinical HIV pharmacist.

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Primary care player Forward shutters after raising $400M, rolling out CarePods

Fierce Healthcare

Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday. | Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday.

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AHA 2024: Tirzepatide Lowers Risk of Worsening Heart Failure, CVD Death in Adults With Obesity

Pharmacy Times

This is the first trial that tested the effect of any medication on major heart failure outcomes in patients with HFpEF and obesity, according to investigators.

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Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

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Q&A: Common Reasons Independent Pharmacies Face PBM Audits

Drug Topics

A conversation with Trent Thiede, PharmD, MBA, president of PAAS National, at NCPA 2024.

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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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H5N1 bird flu virus in Canadian teenager displays mutations demonstrating virus’ risk

STAT

The genetic sequence of the H5N1 bird flu virus that infected a teenager in British Columbia shows that the virus had undergone mutational changes that would make it easier for that version of H5N1 to infect people, scientists who have studied the data say.  There’s currently no evidence the teenager, who remains in critical condition in hospital, infected anyone else.

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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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AHA 2024: GLP-1, SGLT2 Treatments May Lower Risk of Future Heart Attack, Stroke for Stroke Survivors

Pharmacy Times

The 2024 American Heart Association and American Stroke Association stroke prevention guidelines recommend glucagon-like peptide-1 receptor agonists to reduce the risk of stroke in individuals with diabetes and high cardiovascular risk.

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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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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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Community Pharmacists Crucial in RSV Vaccine Education Efforts

Drug Topics

After shared decision making with their community pharmacist, patients were more likely to receive an RSV vaccine.

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Opinion: RFK Jr. says he isn’t an anti-vaxxer. He’s wrong

STAT

If he can make it past the Senate, Robert F. Kennedy Jr. will be the next secretary of Health and Human Services. Since the position was created, each secretary has had significant experience in public health, health care administration, or related government work. None has listed “spreading vaccine misinformation” as their primary health care experience.

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Amazon One Medical rolls out telehealth treatment services in competition with Ro, Hims & Hers

Fierce Healthcare

Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care. | Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care.

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FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label

Pharmacy Times

The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.

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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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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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COVID-19 Significantly Impacted Health Services for Patients with Pancreatic Cancer

Drug Topics

Researchers analyzed the impact of the COVID-19 pandemic on outcomes for patients with pancreatic cancer living in England.

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STAT+: Two drugs look promising for lipoprotein(a), a common genetic risk factor for heart disease

STAT

CHICAGO — Lipoprotein(a) is a risk factor for cardiovascular disease you may not hear about in your annual physical. Like LDL, or “bad” cholesterol, too much of the LDL-like particle can create plaque that clogs arteries, creating potential blockages that lead to heart attacks or strokes. It’s also implicated in aortic stenosis, when the aortic valve narrows, pinching blood supply to the rest of the body.

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J&J sues HRSA for blocking controversial 340B rebate plan

Fierce Healthcare

Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. | Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. J&J is suing the Health Resources and Services Administration for blocking the implementation of its new 340B rebate model.

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What Will Happen if Millions of Americans Lose Access to GLP-1s at the Same Time?

Pharmacy Times

There has never been such widespread and popularized use of compounded products due to shortages. Will consumers rise up with pitchforks if the party is shut down?

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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In boost to GSK's £3B plan for Blenrep, myeloma ADC shows survival edge over J&J's Darzalex

Fierce Pharma

GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.

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First U.S. case of new mpox strain detected in California

STAT

California has detected the country’s first case of a new mpox strain that is spreading from person to person. The infected individual had recently traveled from Eastern Africa, where multiple countries are battling transmission of this virus. The individual was treated in a health facility in San Mateo County and is in isolation at home, the California Department of Public Health announced in a statement released Saturday.

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FDA advisory committee to roll up sleeves on generative AI

Fierce Healthcare

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. | The FDA seeks advice on regulatory challenges it has identified for generative AI used in medical devices, which include uncertainty about the foundation model, hallucinations and the ability to define intended use.

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Insights on Innovation: Craig Beavers Previews AHA 2024 and Emerging Trends in Cardiovascular Care

Pharmacy Times

Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, CACP will be moderating a session about social determinants of health and heart failure.

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Syndax gets FDA okay for first-in-class leukaemia drug

pharmaphorum

Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another

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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

STAT

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI.  This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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FDA Grants Fast Track Designation to Potential Gene Therapy for Osteoarthritis of the Knee

Pharmacy Times

GNSC-001 is a first-in-class gene therapy designed to offer long-term relief of musculoskeletal diseases such as osteoarthritis.

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