pharmaphorum

MARCH 25, 2022

Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. Fitbit is already approved by the FDA to provide electrocardiogram (ECG) monitoring of heart rhythms, and in 2020 its Sense Smartwatch was cleared by the regulator to use the ECG functionality to detect AFib – although that requires active input from the user.

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FDA 122

Pharma Marketing Network

MARCH 25, 2022

Members of a multidisciplinary care team may include physicians, nurses, pharmacists, radiologists, dieticians…the list goes on. But one key member is often omitted: the patient’s caregiver. With an estimated 65 million people serving as caregivers, 1 the role is now a factor in an ever-increasing list of healthcare priorities. Although the caregiver is seen as an extension of the patient and their role is not strictly defined, they are informal members of the front-line care team.

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Labelling FDA 98

pharmaphorum

MARCH 25, 2022

In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without digging further, one might think the current case for digital therapeutics is weak.

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FDA 115

Outsourcing Pharma

MARCH 25, 2022

The Pancreatic Cancer Action Network has engaged five new clinical trial sites in the US, which will aid in evaluation of Novartisâ investigational therapy.

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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

MARCH 25, 2022

The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for their Cabenuva product that does away with the need for an oral lead-in period. The label update means that people living with HIV who want to trade their daily oral doses of antiretroviral therapy (ART) for an injection delivered once a month or every two months will no long need to transition to oral therapy with the active ingredients in Cabenuva

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FDA Labelling 98

Pharma Times

MARCH 25, 2022

The site in Kent will support the manufacture of regulatory approved cannabis-based medicines while also leveraging environmental practices

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Pharma Times

MARCH 25, 2022

STP1 has demonstrated good safety and tolerability profiles, while also showing positive results for neurological function

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pharmaphorum

MARCH 25, 2022

Jazz Pharma has started construction of a manufacturing facility in the UK that will be used to manufacture cannabinoid drugs from its recently acquired GW Pharma subsidiary. The 60,000 sq. ft. facility at Kent Science Park (KSP) in Sittingbourne is due to open in 2024, and when fully operational will create more than 100 new highly skilled jobs. It will be used to build capacity for Jazz’s two approved cannabinoid medicines – Sativex (nabiximols) and Epidiolex/Epidyolex (cannabidiol) – as

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Chemotherapy 98

pharmaphorum

MARCH 25, 2022

MEI Pharma and partner Kyowa Kirin have had to abandon plans to file for approval of their PI3K inhibitor zandelisib in B cell lymphoma, after being “discouraged” by the FDA from making the attempt based on a phase 2 study. The partners said that the FDA has advised that a randomised trial is now needed to adequately assess drug efficacy and safety of PI3K inhibitors, so they will have to await the completion the ongoing phase 3 COASTAL trial of zandelisib before they can file.

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FDA 52