pharmaphorum

DECEMBER 23, 2021

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.

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FDA Documentation 118

Fierce Healthcare

DECEMBER 23, 2021

Supreme Court sets Jan. 7 special hearing on vaccine mandate for healthcare workers. hlandi. Thu, 12/23/2021 - 15:41.

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Vaccines 126

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year after it was given a green light in Europe.

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Labelling FDA 105

Fossil Remedies

DECEMBER 23, 2021

When you run a PCD Pharma Company , your prime objective is to earn profit. For that,it is essential to generate a greater number of queries. When you do it, the business performs well. When it performs well, you enhance your market position. Bigger sales mean your company is viewed as a successful company. What are the different ways of generating enquiries?

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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.

pharmaphorum

DECEMBER 23, 2021

COVID-19 has changed everything – at least that’s David Hunt’s plan for pharmaceutical marketing. The former CEO of Havas Lynx recently launched a new agency in the US called The Considered, with the intent to break the traditional pharma marketing rules and shake up the industry. “There is some brilliant work that takes place by some incredibly intelligent agencies and individuals, but I know how formulaic we’ve become as an industry where next year’s tactics are probably very similar to this y

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Communication Vaccines 98

Pharma Times

DECEMBER 23, 2021

Government vaccine advisers have said vulnerable primary school children should be offered a low-dose of a COVID-19 vaccine.

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Vaccines 43

Pharma Times

DECEMBER 23, 2021

WHO officials remain cautious about claiming Omicron as a milder variant of the COVID-19 virus.

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Vaccines 45

pharmaphorum

DECEMBER 23, 2021

Children in England with peanut allergies could be among the first in Europe to get access to Aimmune’s oral immunotherapy Palforzia, after the drugmaker agreed a supply deal with NHS England. The deal comes as cost-effectiveness watchdog NICE recommended Palforzia for NHS use in draft guidance published today which says the drug can be effective in inducing tolerance to peanuts and reducing the severity of allergic reactions, including potentially life-threatening anaphylaxis.

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pharmaphorum

DECEMBER 23, 2021

Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for a surge in Omicron cases over the holiday period. The green light means that Paxlovid – based on nirmatrelvir (formerly PF-07321332) and ritonavir – has been cleared for use in the US ahead of rival therapy molnupiravir from Merck & Co and Ridgeback Biopharma, which was filed with the FDA earlier.

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FDA Hospitals 52