Sun.Dec 18, 2022

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EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

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Access solutions: the missing link that prevents biopharma innovation from reaching patients

pharmaphorum

We live in unprecedented times, where innovation in biosciences continues to accelerate. Science has taken a vertical growth trajectory, yet such innovations are, at best, slow to reach the patients in need. We believe that innovation in patient access models is the necessary catalyst to aid patients in starting on and staying on the therapies they need to improve their lives.

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2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line

Fierce Pharma

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line. aliu. Sun, 12/18/2022 - 17:18.

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Swiftly consumer survey: Majority of shoppers struggle to pay grocery bills

Drug Store News

The survey revealed that nearly all respondents are using some form of loyalty tool to offset higher costs due to current economic challenges.

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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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Episode 528: Proving you don’t need to repeat cholesterol measurements?

Therapeutics Education Collaboration

In episode 528, James and Mike go through the logic and math around CVD risk estimates with regard to repeat cholesterol measurements. We discuss the impact remeasuring cholesterol has on CVD risk estimates and show that re-measuring every 5-10 years provides minimal if any value when it comes to making treatment decisions. All you need to do is look at a person’s drivers license.

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Dry Cough Remedies You Need To Know

BuzzRx

Coughing is a natural reflex and defense mechanism by which the body removes irritants from the respiratory tract. Though coughing can be unpleasant or even painful if it happens for a long time, coughing protects the body by removing irritants from your lungs and airways. There are different types of coughs based on their duration and the sound they make.

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2023 BCPS Exam – What You Need To Know

Med Ed 101

The 2023 BCPS exam will not undergo significant changes compared to 2022. In the ten years I have spent following, studying, and providing study materials for this exam, there have been about 3-4 major changes. There are no planned changes to the content outline for 2023. In this article, I will outline previous pass rates, […]. The post 2023 BCPS Exam – What You Need To Know appeared first on Med Ed 101.

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Cannabidiol oil adds no value to palliative care in advanced cancer

Hospital Pharmacy Europe

An RCT found cannabidiol oil given to adults with advanced cancer and symptom distress did not add value to specialist palliative care alone. Cannabidiol (CBD) oil use in patients with advanced cancer receiving palliative care, provides no additional benefit to that care according to the findings of a randomised trial by Australian researchers. Although there have been several advances in medical care, a proportion of patients with advanced cancer still experience substantial symptom distress.

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FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

The FDA Law Blog

By McKenzie E. Cato & Allyson B. Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction.

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