Mon.Feb 20, 2023

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Patients With Diabetes Taking Pioglitazone Less Likely to Develop Dementia

Drug Topics

Not only were people with newly diagnosed type 2 diabetes less likely to develop dementia if they took pioglitazone, but the benefit was stronger among patients with a history of ischemic heart disease or stroke.

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Opinion: Medicaid during incarceration: a step toward health equity

STAT

As a physician caring for chronically ill individuals recently released from incarceration, I’ve become accustomed to working as a detective of sorts, trying to piece together the care they received while incarcerated in an attempt to recreate their medical histories and treatment plans. Since they are often released without medical records, prescriptions, and other lifesaving information, I ask questions like, “Do you remember your doctor’s name?

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Trending Sources

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NJ and CO Governors Partner to Support Youth Mental Health

Drug Topics

United States leaders work together to create bipartisan solutions for the youth mental health crisis.

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A device restored hand movement for two stroke survivors. Researchers want to take it mainstream

STAT

Heather Rendulic yearns to use both hands to fill up her plate at a hotel buffet, or slice up her own steak. She wants to pull her hair into a ponytail. She’s tried to teach her husband, but it always comes out a bit messy. Almost nine years after a stroke paralyzed the left side of her body at age 23, Rendulic sat in a lab at the University of Pittsburgh and used her left hand to cut a steak.

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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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US FDA approves Apellis’ geographic atrophy therapy Syfovre

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers dosing flexibility with a regimen of every 25 to 60 days for patients and physicians.

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‘Caught in the middle’: A battle between Vertex and insurers is leaving cystic fibrosis patients with crushing drug costs

STAT

Dan Brickey was stunned when he learned the news. The cost of the cystic fibrosis medicine that his 2-year-old daughter, Ali, had recently started taking was about to climb from just $180 out of pocket each year to a whopping $43,600 in 2023. The dramatic change was due to a decision by the drug’s manufacturer, Vertex Pharmaceuticals, to slash the amount of financial assistance that it offers to patients this year.

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Three quarters of pharmacists say antibiotic shortage continues

Outsourcing Pharma

A survey conducted to understand whether supply issues over amoxicillin have persisted in the US found that an overwhelming majority of pharmacists are still struggling to source the commonly-used antibiotic.

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Nationwide Plan to Transition Out of COVID-19 Public Health Emergency Called for by Family Physicians

Drug Topics

Federal regulators need to address potential policy changes that could affect primary care.

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Peracetic acid-UV light treatment could improve microbial water quality

European Pharmaceutical Review

A peracetic acid (PAA)–ultraviolet (UV) combination treatment significantly decreased microbial counts of samples in a pharmaceutical water system, researchers have found. The paper , published in the Journal of Water, Sanitation and Hygiene for Development presented a monitoring programme for microbial disinfection and sanitation of purified water (PW) and water for injection (WFI) systems in a pharmaceutical plant.

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Are weight loss injections the solution to the obesity crisis? – podcast

The Guardian - Pharmaceutical Industry

Ian Sample speaks to Guardian science correspondent Nicola Davis about the news that Wegovy, an appetite suppressant popular with celebrities in the US, will soon be sold at UK pharmacies. It’s a prescription drug aimed at helping people with obesity lose weight, but some argue it doesn’t tackle the root cause Clips: BBC, abc7NY Continue reading.

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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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The 2023 Controlled Substance Assessment Quiz

OctariusRx

The 2023 controlled substance assessment quiz is about to be released! This is our first annual competency assessment focused on controlled substances and regulatory compliance. Ongoing education and assessments of staff in the handling of controlled substances not only helps with compliance, it’s also a great way to enhance patient safety. How are you assessing your staff?

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2022 UK life sciences recruitment report revealed

European Pharmaceutical Review

According to a new report on UK life sciences recruitment, there were 11,200 new professional scientific vacancies in the industry across England and Wales in 2022. Among the most in-demand roles, laboratory was the busiest scientific function, surpassing 1k in new scientific vacancies, the research showed. The report by Cpl Life Sciences and market data analysts Vacancysoft found that within the laboratory function: From 2020-22, there were over 2,700 job postings In 2022, there were over 1,000

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First potential APDS treatment developed by Pharming Group hits EU regulatory delay

Outsourcing Pharma

The Dutch company Pharming Group N.V. has switched its rare disease drug leniolisib from an accelerated assessment to a regular review with the European Medicines Agency (EMA).

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Medtronic’s extravascular defibrillator receives CE mark

Pharmafile

Medtronic has received CE mark for its extravascular defibrillator. The Aurora EV-ICDâ„¢ MRI SureScanâ„¢ and Epsila EVâ„¢ MRI SureScanâ„¢ defibrillation lead treat abnormally fast heart rhythms which can lead to sudden cardiac arrest. Implantable cardioverter-defibrillators (ICDs) are a highly effective treatment for sudden cardiac arrest (SCA). They detect when the patient is experiencing an abnormally fast heart rate and deliver therapy to terminate a potentially fatal arrhythmia.

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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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Celanese partners with Johns Hopkins on eye drug delivery

Outsourcing Pharma

The partners will collaborate on a study of sustained drug delivery to the suprachoroidal space in the eye.

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FDA approves Apellis’ geographic atrophy treatment

Pharmafile

Apellis’ Syfovre (pegcetacoplan injection) is indicated for patients with geographic atrophy (GA) with or without subfoveal involvement, and has received approval from the FDA. GA is an advanced form of age-related macular degeneration (AMD), which can lead to permanent loss of vision, affecting over 8 million people worldwide. Syfovre is claimed to be the first treatment to be approved for GA and offers dose flexibility for patients and physicians with a schedule of every 25 to 60 days.

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Cloud ERP to Support Commercial Readiness

PharmExec

When a company reaches late-stages of clinical trials testing new drugs, systems need to be created to manage the manufacturing, sales, costs, internal controls, and more. A successful transition into commercializing a new drug depends on putting in place the right infrastructure and systems.

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Relationship between Sunlight, Vitamin D, and Seasonal Affective Disorder (SAD)

indispensable health

Sunlight, vitamin D, and seasonal affective disorder (SAD) are all interconnected. Sunlight is a primary source of vitamin D, which is essential for the body to absorb calcium and maintain healthy bones. When the skin is exposed to sunlight, it produces vitamin D. However, during the winter months or in areas with limited sunlight, such as in the polar regions or during extended periods of time indoors, people can experience a vitamin D deficiency.

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Ide-cel prolongs PFS in refractory or relapsed multiple myeloma compared with some standard regimens

Hospital Pharmacy Europe

The CAR T-cell therapy Ide-cel provided greater progression-free survival than five other regimens in relapsed or refractory multiple myeloma A randomised controlled trial has shown that Ide-cel (idecabtagene vicleucel), a CAR T-cell therapy, generated a significantly longer period of progression-free survival than any of five other standard regimes in heavily pre-treated patients with relapsed or refractory multiple myeloma.

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7 Proven Productivity Habits to Live By

indispensable health

There are many productivity habits that successful CEOs use to manage their time and stay productive. Here are seven of the best productivity habits that successful CEOs useto support their effectiveness: 1. Prioritizing tasks: Successful CEOs prioritize tasks based on their level of importance and urgency. This helps them stay focused on the most critical tasks and ensures they make the most of their time.

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FINN Partners and Hyderus Unite for Global Health Communications and Policy Practice

PharmExec

Move enables FINN to address pressing health priorities in developed and developing nations and expands Hyderus global service capabilities and client offerings and Hyderus co-founders Mark Chataway and Christopher Nial join FINN global health leaders team.

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FDA gives priority review to Merck’s new drug application for kidney disease

Outsourcing Pharma

The US Food and Drug Administration (FDA) has accepted Merckâs Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in kidney transplant patients for priority review.

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Stryker’s Q Guidance System received FDA clearance for cranial applications

Pharmafile

Stryker, a medical technology company, has announced that its Q Guidance System with Cranial Guidance Software received 510(k) clearance from the FDA. Its system for spinal applications is currently on the market.

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Gen Z and Millennials Turning to Social Media for Health Guidance Instead of HCPs

PharmExec

A new study shows that a growing number of younger generations are turning to social media platforms such as TikTok and Instagram influencers for health advice.

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Pfizer’s Lyme disease vaccine study cut due to protocol violations

Pharmafile

Valneva and Pfizer have seen their Lyme disease vaccine study cut down after some clinical trial sites were revealed to be not adhering to Good Clinical Practice (GCP) standards. Almost half of the trial’s participants will be withdrawn following these GCP violations. The protocol violations took place in trial sites run by third-party trial operator, Care Access, meaning that approximately half the patients in the VALOR study will be withdrawn from testing.

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Piramal begins production at API facility in Michigan

Outsourcing Pharma

The Indian company begins production of APIs and HPAPIs, after expanding capacity at its Riverview site.

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BMS Reports P-III Trial (CheckMate-274) Results of Opdivo (nivolumab) for High-Risk Muscle-Invasive Urothelial Carcinoma

PharmaShots

Shots: The 3yr. follow-up results from the P-III trial (CheckMate-274) evaluating Opdivo (240mg, q2w for ~1yr.) vs PBO in a ratio (1:1) in 709 patients with MIUC who are at a high risk of recurrence after radical resection The results showed a sustained clinical benefit. Across all randomized patients, m-DFS/m-NUTRFS/m-DMFS/m-PFS2 was (22.0 vs 10.9mos. with 29% risk reduction)/ (25.9 vs 13.7mos.)/ (47.1 vs 28.7mos.)/ (61.2 vs 47.1mos.

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Episode 534: Come Spy with Me: Continuous glucose monitoring in diabetes

Therapeutics Education Collaboration

In episode 534, Mike and James bring Jamie Falk to go through all the evidence for continuous glucose monitors that use subcutaneous sensors. There certainly seems to be evidence of benefit for T1DM but when it comes to T2DM the evidence for a benefit is not clear at all. Have a listen to get all the details. Show Notes Tools for Practice Come Spy with Me: Continuous glucose monitoring in diabetes Annual MEME talk Vancouver May 12/13, 2023 REGISTER NOW In episode 534, Mike and James bring Jamie

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ABN-401 by Abion for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ABN-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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NurExone Reports Preclinical Results of ExoPTEN for the Treatment of Traumatic Spinal Cord Injuries

PharmaShots

Shots: The company highlights results from the preclinical study evaluating the impact of ExoPTEN on the motor, reflex, and sensory recovery of rats following the complete serving of the spinal cord The results depicted that 75% of the rats in the ExoPTEN-treated group responded to treatment and recovered hind limb reflex, rehabilitated some motor function & recovered sensory control.

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BI-685509 by Boehringer Ingelheim International for Systemic Sclerosis (Scleroderma): Likelihood of Approval

Pharmaceutical Technology

BI-685509 is under clinical development by Boehringer Ingelheim International and currently in Phase II for Systemic Sclerosis (Scleroderma). According to GlobalData, Phase II drugs for Systemic Sclerosis (Scleroderma) have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BI-685509’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Takeda Reports Results of Vedolizumab in P-III Trial for the Prevention of Intestinal aGvHD in Patients Undergoing allo-HSCT

PharmaShots

Shots: The P-III clinical trial (GRAPHITE) evaluates the safety & efficacy of vedolizumab (300mg) vs PBO, in the ratio 1:1, as prophylaxis of intestinal aGvHD in patients (n=333) who received allo-HSCT as a treatment for a hematologic malignancy or myeloproliferative disorder from an unrelated donor The study depicted vedolizumab to achieve a statistically significant improvement in intestinal aGvHD-free survival vs PBO on Day 180 after allo-HSCT whereas along with a significant superiority

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Risk adjusted net present value: What is the current valuation of Axsome Therapeutics’s Esreboxetine?

Pharmaceutical Technology

Esreboxetine is a small molecule commercialized by Axsome Therapeutics, with a leading Phase III program in Fibromyalgia (Fibromyalgia Syndrome). According to Globaldata, it is involved in 17 clinical trials, of which 11 were completed, and 6 were terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Esreboxetine’s valuation in its risk-adjusted NPV model (rNPV).

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Telix Presented P-III Results from TLX250-CDx for Kidney Cancer Imaging Study at the ASCO GU 2023

PharmaShots

Shots: The trial results achieved 1EPs and 2EPs and showed an overall sensitivity of (86%), specificity (87%), PPV (93%), NPV (75%), accuracy (86%) for detection of ccRCC in tumors ≤4cm ("T1a" classification) along with safety and tolerability also no unexpected safety signals were observed A case study demonstrated the ability to identify and detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC even in ≤2cm renal masses

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