Tue.Sep 27, 2022

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New Bivalent Omicron-Containing Booster Vaccine May Elicit Higher Antibody Response Against COVID-19

Pharmacy Times

Patients could have a better immune response against the omicron variant of COVID-19 with a second booster of the bivalent mRNA-1273.214 vaccine at a 50 ?g dose.

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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

Vaccines 145
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FDA Approves Omidenepag Isopropyl for Elevated Intraocular Pressure in Primary Open-Angle Glaucoma, Ocular Hypertension

Pharmacy Times

Omidenepag isopropyl ophthalmic solution (Omlonti) eye drops are indicated to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

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‘It is sinking us even further’: STI clinics, already stretched thin, strain under weight of monkeypox response

STAT

At the Los Angeles LGBT Center’s sexual health clinic, patients are normally seen within 24 hours. Recently, amid the monkeypox outbreak , it’s been a five-day wait. At Open Door Health, an LGBTQ+ community clinic in Providence, R.I., a standard test for a sexually transmitted infection might take 15 minutes. Testing for monkeypox — between authorizing the test and donning and doffing PPE — has dragged up to an hour.

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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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Update on Using Dextromethorphan-Bupropion in Depression

Drug Topics

A new—cough, cough—combination treatment for depression. Researchers performed an RCT of dextromethorphan-bupropion in major depressive disorder.

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STAT+: Google and Fitbit launch new cloud tools to help hospitals use wearables

STAT

Google Cloud and Fitbit are rolling out a new offering they hope will ease some of the challenges hospitals face collecting and processing data from wearable devices. The offering, called Device Connect for Fitbit, is one of the first joint public initiatives since  Google acquired Fitbit  for $2.1 billion in 2021. The effort underscores the health care opportunities created by the union, pulling from Google’s data crunching expertise and Fitbit’s wearables know-how to re

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More Trending

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Medicare Advantage boosterism, providers’ surprise billing savior in Texas, and a health insurance firewall

STAT

You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system.  Sign up here  to get it in your inbox. The latest in the Medicare Advantage Discourse. We are at the point in the Medicare Advantage Discourse where health insurers have convinced themselves, and are continuing to try to convince the public, that MA saves taxpayers oodles of money.

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Could vaccines soon be added to the ‘collective arsenal’ against cancer?

pharmaphorum

The emergence of PD-(L1) treatments has provided patients options where previously none existed, and the leading forms of these therapies have gone on to blockbuster sales. Ben Hargreaves finds that the next step to enhance these treatments further could be to find synergies with emerging therapies employing similar modes of action, such as therapeutic cancer vaccines.

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Rimmel London joins Cruelty Free International’s Leaping Bunny program

Drug Store News

The cosmetics brand is now part of Cruelty Free International’s Leaping Bunny program, which signifies that all of its products are now Leaping Bunny approved

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Program for Safer Opioid Supply Shows Positive Results

Drug Topics

Positive effects emerge when patients get medical care, avoid deadly fentanyl-laced street drugs.

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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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Walmart names Kindbody as provider of associate fertility, family-building benefits

Drug Store News

Walmart associates will have access to more than 30 state-of-the-art clinics across the United States, including a new clinic in Northwest Arkansas.

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Help Optimize Care for Orphan, Rare Lung Diseases Amid COVID-19 Pandemic

Pharmacy Times

The value of a patient-first approach and telehealth for addressing the complex health coordination needs of those with these pulmonary conditions has never been more critical.

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New ethical guidance for paediatric clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. The guidance , called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices.

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Akorn to pay $7.9M to resolve allegations of fraudulent billing

Drug Store News

Akorn caused Medicare Part D to pay for three Akorn generic drugs that were no longer eligible for Medicare coverage.

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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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HPLC determination of common cold formulations

European Pharmaceutical Review

Researchers have developed and optimised a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous detection of chlorpheniramine maleate (CPM) and ibuprofen (IBF) in a pharmaceutical formulation. CPM and IBF are one of the most prevalent over-the-counter cold and cough medications, available in various multi-component formulations.

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Giant recognized by EPA’s GreenChill program

Drug Store News

The EPA’s GreenChill program recognized Giant for reaching its annual refrigerant emissions reduction goal in 2021.

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Pfizer and BioNTech seek EUA for Omicron-based Covid-19 booster in children

Pharmaceutical Technology

Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children. The companies sought authorisation for booster vaccine usage in children aged five to 11 years. Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/

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Schnucks to acquire 2 Fricks Market locations

Drug Store News

Schnuck Markets announced its intent to acquire two Fricks Market locations in Missouri.

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How to get the Inside Track for Your Monkeypox EUA

The FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak.

FDA 59
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Walmart appoints Howard Hacker as VP of health and wellness compliance

Drug Store News

Hacker will be responsible for overseeing health-and-wellness compliance for clinics, pharmacy and optical operations, as well as the underlying compliance programs tied to them.

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Herbal product Kamini may be causing opioid dependence in Australia, doctors warn

The Guardian - Pharmaceutical Industry

Use of Ayurvedic medicine Kamini Vidrawan Ras resulted in 24 reported presentations to addiction clinics in Queensland and Victoria Get our free news app , morning email briefing or daily news podcast A herbal “remedy” purportedly for low energy that is often used by shift workers contains opioids and other harmful substances, leading to an increasing number of people seeking help for addiction, doctors have warned.

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QR codes: The key to unfiltered customer feedback

Drug Store News

Nihal Advani, founder and CEO of QualSights, takes a look at how QR codes can be an efficient method of gathering customer satisfaction data for retailers and retail pharmacies.

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Whistleblower gets $250m as Biogen settles US kickbacks case

pharmaphorum

Biogen has finalised a $900 million payment to settle a whistleblower lawsuit claiming that it paid kickbacks to US doctors to prescribe its multiple sclerosis drugs. According to a Department of Justice statement , the payment resolves the suit filed on behalf of the federal government by former Biogen employee Michael Bawduniak, under the whistleblower (qui tam) provisions of the False Claims Act.

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New Developments in Mass Spectrometry-Based Single-Cell Proteomics

BioPharm

Tue, Sep 27, 2022 11:00 AM EDT Learn how Karl Mechtler has developed an end-to-end workflow to efficiently prepare and analyze samples for single-cell proteomics by mass spectrometry. This workflow enables direct injection of single cells to identify approximately 1,500 protein groups per analytical run and uncover the surprising heterogeneity of cell populations.

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Lava fires up a $700m cancer licensing deal with Seagen

pharmaphorum

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.

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Semaglutide reduces 10-year risk of type 2 diabetes in obese patients

Hospital Pharmacy Europe

Semaglutide 2.4 mg weekly with diet and exercise decreased the 10-year risk of type 2 diabetes in obese patients compared to placebo. Semaglutide 2.4 mg when given as a weekly subcutaneous injection to patients who are obese but do not have type 2 diabetes and in combination with diet and exercise, leads to a significant reduction in their 10-year risk of developing type 2 diabetes compared to placebo according to the findings of a study by US researchers presented at the 58 th European Associat

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Pfizer/BioNTech ask FDA for EUA of Omicron bivalent vaccine in children 5+

pharmaphorum

A submission to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) of a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 through 11 years old has been made by BioNTech and Pfizer, it emerged yesterday. With a corresponding application for extension of marketing authorisation at the European Medicines Agency (EMA) to be made in days, the EUA request is supported by safety, immunogenicity, and preclinical data from

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A key fact the White House is reluctant to admit

PhRMA

Today, President Biden delivered remarks that touch on recent drug pricing reforms included in the Inflation Reduction Act. While the law is deeply flawed and government price-setting is the wrong approach for patients, don’t be confused by any political talking points: The biopharmaceutical research industry has long supported capping what seniors in Medicare Part D pay out of pocket for lifesaving medicines.

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Opinion: The Inflation Reduction Act will help the U.S. achieve maximum vaccine access and uptake, but access gaps remain

STAT

One of the many achievements in the Inflation Reduction Act (IRA), which President Biden signed into law in August, is aligning Medicare’s vaccine coverage with that of all private health insurance in the United States. Once implemented, nearly 9 out of 10 of Americans will have access to vaccines with no cost sharing, or what’s known as first-dollar coverage — copays, deductibles, or coinsurance do not apply for receiving any vaccine recommended by the CDC’s Advisory

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On the Brink of Commercialization: How do we bring ground-breaking cell and gene therapies to market faster?

BioPharm

Tue, Sep 27, 2022 2:00 PM EDT | 11am PT | 2pm ET | 7pm BST Many novel cell and gene therapies (CGTs) are now entering the commercialization stage but, as developers look to recoup investment and quickly deliver life-saving therapies to the patients that need them, they face a myriad of challenges. In this webinar, learn how advanced therapy medicinal product (ATMP) platforms, using single-use systems, are delivering streamlined, efficient and cost-effective manufacturing solutions in this dynami

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STAT+: Democrats concede to clean user fee agreement to fund FDA

STAT

WASHINGTON — Democrats have conceded to Republican demands and agreed to fund the Food and Drug Administration for five years without any extra policy reforms attached, according to four congressional aides, a move that will punt any additional fights over FDA policy to December. Democrats have been forced to entirely concede their ambitions to reform FDA programs to the preferences of Sen.

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