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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

In the UK, ARS Pharmaceuticals anticipates filing for approval from the Medicines and Healthcare products Regulatory Agency (MHRA) by Q4 2024, under their Mutual Recognition Process A, where MHRA will review and approve EURneffy based on the EMA approval within 60 days of filing. Hand (N Y). 2007; 2(1):5-11.

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Why Are Patients So Angry? Plus, Frontliner Tips for Health Leaders

Healthcare Success

But first, we must understand what’s happening in healthcare and the world-at-large post-pandemic. To be clear, workplace violence experienced by healthcare workers predates the pandemic. The rate of injuries from violent attacks against medical professionals grew by 63% from 2011 to 2018.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

FDA 98
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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

With an estimated 65 million people serving as caregivers, 1 the role is now a factor in an ever-increasing list of healthcare priorities. If caregiving is positioned as an essential service and caregivers are counted among healthcare’s front-line service providers, 4 does it follow caregivers are a viable healthcare vertical?

Pharma 98
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Health Innovation Fund, Moderna’s largest shareholder, shares investment strategies

pharmaphorum

Jack Torrance, investment specialist for Baillie Gifford’s Health Innovation Fund, tells us how the organisation ensures its investments will have the most significant positive impact on all stakeholders within the healthcare ecosystem. . The status quo in the healthcare sector is an antiquated and fossilised model, Torrance says.

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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Additionally, healthcare payers understand that HCs can provide value by describing potential treatment benefit relative to untreated patients in their populations. Healthcare payers also use clinical trial evidence to assess the effectiveness of treatments in making reimbursement decisions. 2011 May; 46(3): 399–424.