Trending Articles

article thumbnail

FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics

Drug Topics

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

FDA 201
article thumbnail

STAT+: Patient dies in Beam Therapeutics trial of CRISPR sickle cell treatment

STAT

A patient with sickle cell disease died while participating in a clinical trial of a CRISPR-based treatment from Beam Therapeutics, threatening to overshadow early signals of effective gene editing.  Beam said the patient succumbed to respiratory failure, deemed to be “likely caused” by a regimen of chemotherapy required to prepare the patient for BEAM-101, a treatment that uses the company’s new, more precise form of CRISPR gene editing called base editing.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Study Finds Behaviors of Breast Cancer Cells Help Predict Risk of Bone Metastasis

Pharmacy Times

Using in vitro models, study investigators predict the risk of bone metastasis in breast cancer based on correlations with their in vivo behaviors and potential.

118
118
article thumbnail

Doctors, facing another pay cut in 2025, call for permanent Medicare payment reform

Fierce Healthcare

The Centers for Medicare and Medicaid Services (CMS) is moving forward with a 2.9% cut to physician payments in 2025 despite protest from major industry groups. | The Centers for Medicare and Medicaid Services (CMS) is moving forward with a 2.9% cut to physician payments in 2025 despite protest from major industry groups.

130
130
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

Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

132
132
article thumbnail

Q&A: The Importance of Vaccine Literacy, Uptake During Flu Season

Drug Topics

Ruth Carrico PhD, DNP, APRN, discussed the importance of annual vaccination and overall health awareness and literacy during the winter flu season.

Vaccines 211

More Trending

article thumbnail

Pharmacist Involvement Within ASCO: Standards Development, Certification Programs, and the Potential for Pharmacy CE at Future ASCO Meetings

Pharmacy Times

ASCO is prioritizing the expansion of pharmacist involvement in its organization by recognizing pharmacists' contributions to safety standards, quality improvement initiatives, and certification programs.

122
122
article thumbnail

CMS finalizes 2.9% pay increase for outpatient facilities, ASCs, with new maternal health mandates

Fierce Healthcare

Under a final rule issued by the Centers for Medicare and Medicaid Services, outpatient hospital facilities and ambulatory surgical centers will get a 2.9% Medicare pay increase next year, up from | Under a final rule issued by CMS, outpatient hospital facilities and ambulatory surgical centers will get a 2.9% Medicare pay increase next year, up from the 2.6% boost in reimbursement that was floated in the draft rule.

Hospitals 124
article thumbnail

Disc maps out US filing for porphyria drug bitopertin

pharmaphorum

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.

108
108
article thumbnail

Tips For Increasing Your Independent Pharmacy’s Online Visibility | NCPA 2024

Drug Topics

Erin Rexroth, director of marketing at NCPA, discusses how smaller pharmacies can compete with large chains when it comes to digital marketing.

179
179
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

STAT+: These 7 watchdogs scour scientific papers for problems — and often find them

STAT

Researchers like to say that science is self-correcting, that knowledge is slowly but surely refined by new findings that build on or debunk old ones. But this process is far from perfect and is hampered by sloppy experiments or, in some cases, faked results. A small, tight-knit community of scientific sleuths has been unearthing growing evidence that many studies, including landmark papers published in top journals, contain manipulated images and falsified findings.

138
138
article thumbnail

Sublingual Epinephrine Film Promptly Resolves Symptoms in Patients With Oral Allergy Syndrome

Pharmacy Times

Results indicate that sublingual epinephrine can resolve symptoms, including swelling of the face and throat, associated with oral allergy syndrome in minutes.

138
138
article thumbnail

Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia

Fierce Pharma

Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.

110
110
article thumbnail

Community Pharmacies in Crisis: Navigating the Challenges and Closures

Pharmaceutical Commerce

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

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

Q&A: Understanding the Cause of Declining Vaccination Rates Amidst Flu Season

Drug Topics

Ruth Carrico, PhD, DNP, APRN, discussed declining influenza and COVID-19 vaccination rates and how it has created a looming threat for public health officials.

Vaccines 123
article thumbnail

Opinion: Social media misinformation is scaring women about birth control

STAT

In a viral TikTok, a woman in the emergency room shares a message questioning why so many women in their 30s struggle with cancer and infertility, and suggests that birth control’s long-term hormonal disruption is the cause. Another influencer mocks the FDA inserts that accompany birth control, unfolding the long lists of side effects in videos to humorously repurpose them as “blankets” for napping or as tools for helping men grasp the harsh realities their partners face to

FDA 128
article thumbnail

Clofutriben Receives FDA Orphan Drug Designation to Treat Endogenous Cushing Syndrome

Pharmacy Times

The randomized, placebo-controlled RESCUE phase 3 trial assessed clofutriben among individuals with ACTH-dependent endogenous Cushing syndrome.

FDA 123
article thumbnail

Vertex's Casgevy breaks ground with 1st commercial patient infusions as company readies another major launch for 2025

Fierce Pharma

With new approvals on the horizon and the closely watched Casgevy launch picking up steam in sickle cell disease and beta thalassemia, “there has never been a more exciting time to be at Vertex,” c | With its first Casgevy revenues in the books, Vertex lifted its full-year sales outlook as it turns its attention to two product launches in 2025, including an expected new entrant in the pain market.

105
105
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

From neurosurgery to focused ultrasound: Not if, but when

pharmaphorum

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult

98
article thumbnail

Meet the Specialty Pharmacist Championing HIV Care

Drug Topics

Cassandra Esperant, PharmD, AAHIVP, leverages her skills as a clinical pharmacist to champion the health of patients with HIV, both in her clinical practice and through education initiatives.

187
187
article thumbnail

What really happens to drug prices when patents expire

STAT

This is Part 5 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. When patents for name brand medicines expire, the price of that medicine drops significantly as generic versions enter the market. Lower prices are good news for patients seeking more affordable medications, but the change can sometimes take a while.

article thumbnail

Researchers Find Lack of Communication for Lung Cancer Screenings Among High-Risk Individuals

Pharmacy Times

Less than 16% of high-risk lung cancer individuals have heard or discussed lung cancer screenings with a health care provider.

article thumbnail

BioNTech reports surprising COVID vaccine sales in Q3 but tempers expectations for annual sales

Fierce Pharma

BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.

Vaccines 109
article thumbnail

Optum Rx rolling out new initiatives aimed at supporting independent pharmacists

Fierce Healthcare

Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs. | Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.

article thumbnail

Two Independent Pharmacies Latest to Sue Major PBMs

Drug Topics

A collection of independent pharmacies was the next in line to file suits against major pharmacy benefit managers for alleged drug price fixing.

article thumbnail

STAT+: Seven companies to watch in AI protein design

STAT

When this year’s Nobel Prize in chemistry went to three scientists for their work in protein structure prediction and design, the decision was indicative of a zeitgeist in biotech.   “[A] dream of scientists has been to build new proteins, to learn how to use nature’s multitool for our own purposes … opening endless possibilities for the greatest benefit to humankind,” Heiner Linke, chair of the Nobel Prize committee for chemistry, said while announci

122
122
article thumbnail

Researchers Find “Digital Twin” Model Accurately Predicts Treatment Responses for Different Chemotherapy Drugs

Pharmacy Times

This model, which uses technology that discovers black holes, pulls from real data to evaluate cancer treatments, optimizing treatment choices for patients with different cancers.

article thumbnail

NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

108
108
article thumbnail

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

FDA 118
article thumbnail

FDA Approves Journey Medical’s Emrosi for Rosacea

Drug Topics

“Emrosi has potential to become the best-in-class oral medication to treat the condition,” said the CEO of Journey Medical.

FDA 112
article thumbnail

STAT+: These 10 scientists are leading a new generation of gene editors developing CRISPR medicines

STAT

Barely 12 years after the publication of the first papers unveiling CRISPR-Cas9, a powerful enzyme for editing DNA, sickle cell patients are now receiving the first approved CRISPR-based medicine, Casgevy. Hundreds of patients with other inherited diseases, cancers, and chronic bacterial and viral infections are enrolled in clinical trials testing other CRISPR treatments.

144
144
article thumbnail

Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Pharmacy Times

ASHP investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of respondents reporting that they experienced a shortage.

123
123
article thumbnail

Acamprosate vs Naltrexone – Clinical Comparison

Med Ed 101

There are two agents that are frequently used in alcohol use disorder. Acamprosate and naltrexone have distinct advantages and disadvantages in the treatment of alcohol use disorder. In this article, we will compare the clinical benefits and risks of acamprosate vs naltrexone. What do the guidelines say? Both naltrexone and acamprosate are considered first-line treatments […] The post Acamprosate vs Naltrexone – Clinical Comparison appeared first on Med Ed 101.

105
105