Thu.Apr 14, 2022

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FDA draft guidance outlines path to increased trial inclusivity

Outsourcing Pharma

The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

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Patient backlog caused by COVID ‘could take six years to clear’

pharmaphorum

The massive backlog in patient care across Europe resulting from the pandemic will take at least three years to clear and in some cases as long as six years, says a new study. The research from Censuswide stems from surveys of oncologists and surgeons across six European countries, which found that 20% of them estimate clearing the backlog will take between four and six years.

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9 pharmacy technician tips for smooth pharmacy operations

SingleCare

Any pharmacy technician will tell you that a day behind the counter is a busy one. Pharmacy techs can’t do every task that pharmacists do, but they handle a whopping list of duties during their long, on-their-feet-all-day shifts. They count pills, call insurance companies, staff the register and the drive-thru, verify insurance coverage, check inventory, and talk to doctor’s offices, all while answering phones, responding to customer questions and complaints, and sometimes even administering vac

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Pfizer makes bid for ResApp and its respiratory diagnosis apps

pharmaphorum

Pfizer’s Australian unit has tabled an offer to buy ResApp Health and its smartphone apps for the management and diagnosis of respiratory diseases in a deal that values the digital health company at around A$100 million (around $75 million). Pfizer is offering A$0.115 per share in cash for ResApp, a deal which has been accepted by the company’s directors and recommended to shareholders ahead of a vote scheduled in June.

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Position Your Pharmacy for Expansion

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.

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A Guide to Vitamins and Supplements for Women

Compounding Pharmacy of America

Eating a well-balanced, healthy diet is the best way to meet your nutritional needs. However, even with good diet practices, sometimes these needs are still not met. Multivitamins have long been used to help supplement the crucial vitamin and nutrient needs of women at all stages of life. In fact, women need specific vitamins to […]. The post A Guide to Vitamins and Supplements for Women appeared first on The Compounding Pharmacy of America.

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AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

Two years after signing a $3.9 billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The drugmaker has reported top-line results from the phase 1/2 EPCORE trial of epcoritamab as a third-line therapy for relapsed/refractory LBCL, revealing an overall response rate of 63% and a median duration of response of 12 months.

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ICER says bluebird bio’s $2.1m gene therapy is cost-effective

pharmaphorum

US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel in June, by endorsing its proposed $2.1 million price tag. ICER’s assessment is still at the draft stage and could be changed after an ongoing comment period, but will be welcomed by bluebird and other gene therapy developers as they try to set a price for their one-shot treatments that will be accepted by payers.

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ISA Pharmaceuticals announce new trial testing technology for cancers

Pharma Times

Trial of Amplivant will begin in a number of cancer patients including those with ovarian cancer

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Independent health comms agencies rebrand with emphasis on authenticity

pharmaphorum

In a world of a million messages, should authenticity be the common thread tying all pharma communications and marketing activities together? Authentic, knowledgeable communications designed and executed by authentic, knowledgeable professionals is the key to pharma’s success in today’s media landscape. That’s according to the team at the world’s largest association of independent healthcare communications agencies, which has just rebranded from GLOBALHealthPR to Global Health Marketing & Co

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Oligonucleotide Therapeutics and Delivery Conference

pharmaphorum

Oligonucleotide Therapeutics and Delivery Conference 2022. Date: 21st – 22nd September 2022. Location: London, UK. Website: www.oligonucleotide.co.uk/pharmaphorum. Advancements in extra-hepatic delivery of oligonucleotides. The Oligonucleotide Therapeutics and Delivery conference reveals the latest in oligonucleotide discovery and delivery, with presentations on targeted delivery mechanisms, oligonucleotide chemistries and important clinical advances.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.