Mon.May 22, 2023

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Setting the record straight on accelerated approval

PhRMA

As we’ve discussed on this blog before, the U.S. Food and Drug Administration’s (FDA) accelerated approval program has served as a critical lifeline for patients with serious and life-threatening conditions. The program was originally established at the urging of patient advocates during the height of the HIV/AIDS epidemic, in which patients waited years for the FDA to review and approve new treatments.

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FDA Approves First Oral Treatment for Patients With Moderate to Severe Crohn's Disease

Drug Topics

The approval of Rinvoq (upadacitinib) was based on the results of three clinical trials: two induction therapy studies and one maintenance study.

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Study Shows Link Between Nurses’ Work Environment, Hospital-Onset C. Diff

Pharmacy Times

Supportive nurse managers and supervisors as well as nurses’ involvement in organizational governance may help lower hospital-onset Clostridioides difficile infection in acute care hospitals.

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Exploring the Link Between Low Socioeconomic Status and Risk of Invasive Pneumococcal Disease

Drug Topics

Active tobacco use and BMI were inversely related to the risk of developing IPD.

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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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Making sense of AI research in medicine, in one slide

STAT

BOSTON — Scientific journals have become something of a Mad Libs game for GPT: Artificial intelligence can now detect __, or speedily tell the difference between __ and __.  But which of these studies are actually important? How can clinicians sort them out from one another? At a recent AI conference, Atman Health chief medical officer and Brigham and Women’s associate physician Rahul Deo boiled the issue down in a single slide: the riskiest, most impactful studies draw far le

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FDA Approves First Gene Therapy for Patients Aged 6 Months and Older with Serious Genetic Skin Disorder

Pharmacy Times

Beremagene geperpavec completely closed severe blistering and wounds in more than half of all patients with dystrophic epidermolysis bullosa with specific mutations.

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More Trending

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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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Opinion: Checklists to screen for patients’ social needs aren’t helping

STAT

I once saw a patient who came to the emergency room with injuries that were clearly related to domestic violence. Instead of offering a compassionate ear and a blanket to cover her exposed body after an assault, her intake nurse rushed through a checklist intended to screen her for social needs. While facing the computer screen, the nurse asked the patient a series of sensitive questions, including one about whether she had experienced domestic violence.

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Readmission on the Horizon: How EU funding can boost British biotech

Pharmaceutical Technology

Amid high inflation , the latest banking crisis , and the continued repercussions of Brexit, the talent pool at British universities remains a major draw for British biotech. Now, the country’s possible participation in the EU’s Horizon Europe scheme would serve to boost the industry during a challenging time. Recent negotiations between the UK and the EU have opened the country’s prospects to re-joining the Horizon Europe program, which has been welcomed by biotechs and institutions alike.

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2022 Prescription Trends

PharmExec

The market for prescription medicines in the United States was subject to major shifts in use across therapeutic areas in 2022, reflecting changes in patient health needs, the development, and availability of novel medicines, and complex market dynamics.

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CureVac gets an early date in Covid-19 vaccine patent case with Pfizer/BioNTech

Pharmaceutical Technology

The ongoing patent litigation between CureVac and Pfizer /BioNTech will move to a court in Virginia following a request from Curevac, potentially bringing forward the trial date to sometime in 2024. The Covid-19 pandemic saw a proliferation in novel vaccine technologies being produced rapidly. With the emergence of vaccines came accusations of technology encroachment amongst biotech companies.

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Perceived Cognitive Deficits Associated With Post–COVID-19 Condition

Pharmacy Times

Many patients with post-COVID-19 condition reported perceived cognitive deficits early during their COVID-19 infection as well.

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.

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Pharmacists Can Educate Patients, Provide Counseling for Smoking Cessation

Pharmacy Times

OTC nicotine replacement products can come in a transdermal patch, nicotine gum, or lozenges.

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Mayo Clinic, Johns Hopkins and 20 others pledge to join TEFCA, prioritize interoperability

Fierce Healthcare

Mayo Clinic, Johns Hopkins and 20 others pledge to join TEFCA, prioritize interoperability aburky Mon, 05/22/2023 - 17:13

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Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE

Fierce Pharma

Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44

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What is Rh factor?

The Checkup by Singlecare

If you are pregnant or considering becoming pregnant, you may have heard of the Rh factor. You probably want to know if it’s something you need to be concerned about, and you may be confused about what it actually is. This is common—it’s a bit of a confusing concept! Here, we’ll go through the ins and outs of Rh factor, including what it is, what causes it, who is at risk for complications, and what treatment options are available.

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New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval

STAT

WASHINGTON — U.S. health regulators on Monday approved a new, easy-to-use version of a medication to reverse overdoses caused by fentanyl and other opioids driving the nation’s drug crisis. Opvee is similar to  naloxone , the lifesaving drug that has been  used for decades to quickly counter overdoses of heroin, fentanyl, and prescription painkillers.

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Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention

ISPE

Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention Trudy Patterson Mon, 05/22/2023 - 11:34 iSpeak Blog iSpeak Asia-Pacific Regulatory & Industry Views on Drug Shortage Prevention Vivien Santillan Christopher John Potter, PhD 22 May 2023 The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region.

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STAT+: Novo says oral version of Ozempic leads to 15% weight loss

STAT

An oral version of semaglutide, the drug marketed as Ozempic and Wegovy , led to dramatic weight loss in a trial enrolling people with obesity, manufacturer Novo Nordisk said Monday, data that could bolster what is already a blockbuster medicine. In the study, which enrolled nearly 700 adults classified as having overweight or obesity, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%, Novo Nordisk said

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FDA Approves Avapritinib for the Treatment of Indolent Systemic Mastocytosis

Pharmacy Times

Avapritinib has been FDA approved for the treatment of advanced systemic mastocytosis since June 2021.

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‘A textbook case of environmental racism’: The battle over the Brookhaven Landfill

STAT

The area of North Bellport on Long Island sits in the shadows of a massive landfill. This predominantly Black and Latino neighborhood also has the lowest life expectancy on Long Island, as well as the second-highest rates of asthma. Environmental activists do not think this is a coincidence, and for decades they have waged a battle to shut down the Brookhaven Landfill, which they believe is making their community sick.

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Exploring Geographic Barriers to Care Access for Patients With Pulmonary Arterial Hypertension

Drug Topics

Some patients with PAH need to travel long distances, which may impact their access to quality care providers.

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Can Statins Cause Memory Loss and Transient Global Amnesia?

The People's Pharmacy

The relationship between statin-type cholesterol-lowering drugs and memory problems has been controversial for decades. When we first wrote about a link between drugs like atorvastatin ( Lipitor ), lovastatin ( Mevacor ), or simvastatin ( Zocor ) and forgetfulness or brain fog 22 years ago, we were told it was all in our heads. Some health professionals were outraged that we dared to discuss this issue at all.

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Should Health Care Workers Keep Wearing Masks With Patients Now That the COVID-19 Public Health Emergency Is Over?

Drug Topics

According to commentaries published in the Annals of Internal Medicine, doctors remain split on the question.

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Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge

Fierce Pharma

Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04

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Acute Cessation May Help Improve Lung Functioning in Regular E-Cigarette Users

Drug Topics

Exhaled carbon monoxide in vape users significantly decreased between their first and third clinical visits.

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STAT+: Pharmalittle: Many employer health plans won’t pay for obesity drugs; FDA panel rejects Intercept NASH drug

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the familiar routine of online meetings, phone calls, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So to cope, yes, we are brewing cups of stimulation. Our choice so far today is chocolate cappuccino and, as always, we welcome you to join us.

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Acetazolamide Treatment Could Help Improve Obstructive Sleep Apnea

Drug Topics

A higher dose of the carbonic anhydrase inhibitor does not seem to provide any additional improvements.

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Saba Syed receives NASP Excellence in Innovation Award

Drug Store News

The Excellence in Innovation Award recognizes qualified pharmacists who have demonstrated significant innovation in their practice, method or service.

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Dapagliflozin use in heart failure extended by NICE to reduce hospitalisations

Hospital Pharmacy Europe

NICE has recommended the extension of dapagliflozin as a treatment option for symptomatic chronic heart failure in patients with preserved or mildly reduced ejection fraction. In final draft guidelines , the committee said it had reviewed evidence from AstraZeneca that adding dapagliflozin (Forxiga) to standard care with diuretics reduces the combined risk of dying from cardiovascular causes or hospital admission with heart failure.

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Cefaly Technology touts OTC wearable medical device for migraine pain

Drug Store News

Cefaly Technology is offering Cefaly, an FDA-cleared, over-the-counter wearable medical device that aims to help relieve migraine pain and reduce frequency.

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Benefits of blockchain in limiting counterfeit drug distribution

European Pharmaceutical Review

A review by Swedish researchers has identified the benefits of smart contracts on blockchain platforms in the pharmaceutical supply chain and its role in combating counterfeit drugs. While the counterfeit market is estimated to be a market of over $200 billion and despite its benefits, blockchain technology has not been fully implemented in the pharmaceutical supply chain, according to the paper.

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With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec

Fierce Pharma

With Dupixent leading the way, Sanofi’s taking on the 'big players' in respiratory diseases: exec kdunleavy Mon, 05/22/2023 - 07:33

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Dismayed reactions from sector over proposed GPhC fees increase

Hospital Pharmacy Europe

More transparency is needed about where General Pharmaceutical Council (GPhC) fees are spent if pharmacy professionals are to be asked to pay more, pharmacy representatives have said. Last week, the GPhC proposed raising its fees by 7.5% – meaning that from April 2024, the pharmacist registration renewal fee would increase by £19, from £257 to £276.

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EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa

Pharmaceutical Technology

The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages. The application is supported by results from the Phase III XTEND-1 trial in adults and adolescents and backed by the XTEND-Kids paediatric trial in patients aged under 12 years.

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