pharmaphorum

APRIL 19, 2022

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and showed that the drug offered an oral alternative to injectable erythropoietin stimulating agents (ESAs) for anaemia, without sacrificing efficacy.

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FDA 121

Outsourcing Pharma

APRIL 20, 2022

The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.

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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

Roots Analysis

APRIL 21, 2022

What is Sustainability and Why is Sustainability Important? The term sustainability is derived from the Latin word sustinere, which means to hold or support. Sustainable packaging is defined as packaging that is safe for individuals, as well as the environment, while meeting all requirements for performance, cost and ease of fabrication. Further, the product should be specially designed in order to minimize usage of raw material and optimize energy use.

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Packaging 52

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 21, 2022

A study has found that there is still a very high level of inappropriate antibiotic prescribing to patients in the US, particularly to older and Black patients. Sifting through data from around seven billion outpatient visits to doctor’s offices, hospital clinics and emergency departments over a seven-year period, the researchers found that almost three-quarters (74%) of antibiotics prescribed to patients aged 65 years or older, and two thirds (64%) to Black patients, were unnecessary.

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Hospitals 120

Outsourcing Pharma

APRIL 20, 2022

An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.

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indispensable health

APRIL 20, 2022

Indispensable Health’s pharmacy staffing department, Staff Rx , discussed the work experiences of our talented staffing pharmacists and pharmacy technicians in order to provide others with advice who may be considering working for a staffing agency. What’s different about working with a staffing agency as a pharmacist, pharmacy technician, or any interim pharmacy professional?

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Communication Hospitals 52

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 108

Outsourcing Pharma

APRIL 21, 2022

The latest news on expansions, innovations, awards, and more includes items from Eversana, DHL Supply Chain, X-Chem, Medidata, and other notable companies.

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Roots Analysis

APRIL 20, 2022

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. Further, studies indicate that more than 100,000 tons of pharmaceutical products are consumed globally per year. In addition, over the next five years, the global pharmaceutical market is projected to grow at a CAGR of 4.7%, with global drug sales anticipated to raise revenues worth USD 1.5 trillion in 2023.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Labelling 52

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Med Ed 101

APRIL 20, 2022

Throughout my career, I have had various clinicians develop trends in the NSAID that they prefer to use. Why do we choose ibuprofen versus diclofenac versus piroxicam? In this post, I will be ranking NSAIDs according to their GI risk based upon the literature we have. This may help explain why we choose one NSAID […]. The post Ranking NSAIDs According To GI Risk appeared first on Med Ed 101.

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pharmaphorum

APRIL 19, 2022

Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare system. COVID spotlighted the vulnerability of the healthcare system and the need for structural and technological change to help manage such as crisis. Though some regions have started to make the necessary changes, Youssef says Europe is lagging. “In general, there is a good progression in almost every country.

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Outsourcing Pharma

APRIL 19, 2022

Cryoport Inc has acquired Cell&Co BioServices, continuing its EMEA expansion efforts.

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Roots Analysis

APRIL 19, 2022

Over the past decade, the biopharmaceutical industry has witnessed several advancements in terms of bioprocessing. Bioprocess technology is one of the integral parts of biotechnology that deals with different biological processes involving living or competent cells to get value added products at the end of the process. Recently, an increasing demand for various efficient technology is has been observed in the biopharmaceutical industry where, single-use technology has emerged as one of the most

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Pharmacy Management Software

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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pharmaphorum

APRIL 19, 2022

AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year.

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FDA Chemotherapy 105

Outsourcing Pharma

APRIL 19, 2022

The one-year-old organization is giving $50m USD in grants to encourage scientists from five cancer research centers to work together on cancer solutions.

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Med Ed 101

APRIL 17, 2022

The post Tamsulosin And Cataract Surgery – Case Study appeared first on Med Ed 101.

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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

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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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

Pharma Times

APRIL 21, 2022

The new guidelines focus on key areas of prescription, management of withdrawal and severity of withdrawal symptoms

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Prescription Management 48

pharmaphorum

APRIL 20, 2022

A meta-analysis of published studies looking at web- app- or telehealth-based therapy for osteoarthritis has concluded that they outperform standard approaches to care. The study – published in the journal Osteoarthritis and Cartilage – focused on patients with osteoarthritis of the hip or knee, and compared the digitally-delivered exercises to standard approaches such as in-person physiotherapy, other forms of care, waitlisting and patient education.

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Outsourcing Pharma

APRIL 19, 2022

The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.

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pharmaphorum

APRIL 19, 2022

Just days after dosing its first patient in a Duchenne muscular dystrophy trial, US biotech PepGen has pushed the button on an initial public offering (IPO). The Boston-based company has filed with the US Securities and Exchange Commission to raise up to $115 million from the IPO, according to a Renaissance Capital report. The funding will be used to continue the clinical development of lead oligonucleotide PGN-EDO51 for DMD, as well as two other oligo drugs PGN-EDODM1 for myotonic dystrophy ty

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pharmaphorum

APRIL 20, 2022

Teva’s long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company’s long-acting formulation of schizophrenia drug risperidone. The US regulator issued a complete response letter (CRL) for the MedinCell-partnered drug, and the companies haven’t been forthcoming on the reasons behind the rejection, saying merely that they would work with the FDA to try to get the programme back on track.

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FDA 97

pharmaphorum

APRIL 21, 2022

The era of patient engagement is over. Instead, it’s time to move towards true partnership at every step of the pharma value chain, from R&D to manufacturing. Partnership is the ethos behind UCB’s new patient-centred framework, which provides colleagues in all business functions with a tangible roadmap on how to effectively work with patients. Iris Loew-Friedrich, the organisation’s chief medical officer and head of development, tells pharmaphorum how the initiative will help guide the creat

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Documentation 97

pharmaphorum

APRIL 19, 2022

The industry has long sought the insight and advice of revered, influential figures. Typically, these key opinion leaders (KOLs) are researchers, physicians, or other healthcare providers (HCPs) that hold high levels of expertise in their respective fields. However, as the industry moves to occupy more virtual spaces, a new breed of industry influencers has emerged – digital opinion leaders (DOLs).

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pharmaphorum

APRIL 21, 2022

One of the leading companies in the bid to bring a new class of alpha-synuclein targeting drugs to market for Parkinson’s disease – AbbVie – is ducking out of the challenge. The pharma company has decided to end its collaboration with Swedish biotech BioArctic on alpha-synuclein-targeting antibody ABBV-0805, which was in early-stage clinical testing, as well as a portfolio of follow-up antibodies.

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pharmaphorum

APRIL 20, 2022

Gilead has won a crucial court order in a wide-ranging lawsuit against a network of clinics, prescribers, medical labs and pharmacies in Florida that it claims have been making fraudulent reimbursement claims for HIV medicines. The suit focuses on alleged abuse of Gilead’s Advancing Access programme, a scheme set up in 2004 to provide HIV therapies at no charge to people who lack heath insurance and would be unable to get access to the drugs.

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Insurance 69

pharmaphorum

APRIL 21, 2022

Diagnosing Parkinson’s in the earliest stages before symptoms become serious is a major challenge in medicine, and digital health company PreciseDx thinks it may have a solution to the problem. The Mount Sinai Health System spinout has developed an artificial intelligence-powered digital pathology system that it says can accurately diagnose Parkinson’s in the early stages, when symptoms may be varied and it may be confused with other conditions.

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Communication 64

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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pharmaphorum

APRIL 22, 2022

Sweden’s Vicore Pharma has started a clinical trial of a digital therapeutic (DTx) intended to relieve anxiety in patients with idiopathic pulmonary fibrosis (IPF), a debilitating and progressive respiratory disease with no curative treatment. The COMPANION study will test a cognitive behavioural therapy-based DTx called Almee (formerly VP04) – developed in partnership with digital health company Alex Therapeutics – to see if it can reduce the psychological symptom burden in adults diagnos

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Immunization FDA 59