pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. Shares in the US biotech have fallen sharply after it revealed that the regulator did not accept changes to a phase 3 trial of the drug – called Ampion – that the company put forward in order to make it serve as a confirmatory pivotal study.

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FDA Immunization 111

Board Vitals - Pharmacist

APRIL 22, 2022

Completing your CME requirements does not have to be stressful or time consuming. No matter how many hours you are due to complete this year, there are a number of options to help you through the process without impacting your busy schedule. Here are some of the top ways to earn CME quickly and easily. . Live CME Conferences . Events sponsored by an accredited CME provider include national, regional, or local conferences, workshops, seminars, journal clubs, simulation labs, and live webinars.

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Documentation 52

pharmaphorum

APRIL 22, 2022

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for rare disease X-linked myotubular myopathy (XLMTM), which was placed on clinical hold by the FDA last year after four patient deaths liked to pos

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Labelling Vaccines FDA 105

Outsourcing Pharma

APRIL 22, 2022

Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.

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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

APRIL 22, 2022

In March 2022 , Leela Barham argued that, in light of new highs in the number of non-submissions to UK’s HTA agency, NICE, it was time to ask companies why they choose not to submit. In this piece, she provides an independent view of the reasons companies have given through an anonymous survey conducted by the industry body, the ABPI. ABPI survey. The ABPI surveyed their members in March 2021, including questions relating to terminated appraisals for non-submissions to NICE between 2016 and 2021

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Pharma Times

APRIL 22, 2022

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

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Pharma Times

APRIL 22, 2022

Infertility is estimated to affect one in seven couples across the UK and can have a profound effect on mental health

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pharmaphorum

APRIL 22, 2022

Reify Health has completed fourth-round financing that adds $220 million to its cash reserves and pushes its valuation up to a heady $4.8 billion, with plans to use the new cash to launch a new initiative to make sure clinical trials are inclusive and diverse. The need for diversity in clinical trial populations has been a topic of discussion by regulators and industry for decades, and while efforts have been taken to widen the net when it comes to patient recruitment, there is much more to be d

FDA 52

FDA 52

Pharmacy Friday Pearls

APRIL 22, 2022

Download PDF. Introduction. Rapid sequence intubation (RSI) is a process whereby an induction agent and a neuromuscular blocking agent are given in rapid succession to facilitate endotracheal intubation The selection of a specific sedative depends on multiple factors: the clinical scenario, which includes patient factors (includes cardiorespiratory and neurologic status, allergies, comorbidity) and the clinician’s experience/training and institutional factors, as well as the characteristics of t

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Documentation 40