pharmaphorum

MARCH 11, 2022

A consortium led by the Digital Medicine Society (DiMe) has been set up to try to end inequities in access to clinical trials, focusing on the increasing number of studies that use digital devices to allow participation. The organisation has teamed up with drugmakers GlaxoSmithKline and Amgen as well as partners in the clinical research, patient engagement and data analytics sector on a project to develop the principles that can be used to make sure trials are designed from the ground up to allo

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Policy Prescription

MARCH 11, 2022

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. The case pertained to an indictment of CanadaDrugs, Ltd. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs.

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FDA 52

pharmaphorum

MARCH 11, 2022

Venatorx Pharma has moved a step closer to what has unfortunately become a rare event in pharma – the filing of a new antibiotic designed to tackle the increasing pressing problem of antimicrobial resistance. Armed with positive phase 3 results, Venatorx has said till file for approval its cefepime-taniborbactam combination with the FDA later this year for complicated urinary tract infections (cUTI), including sever kidney infections (acute pyelonephritis).

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FDA 69

indispensable health

MARCH 11, 2022

A Budget Paradox: Prioritizing Pharmacy Operational Efficacy & Improving Patient Outcomes Considering the sharp decline of hospital revenues, one of the key impactors of a hospital budget is the inpatient drug spend. There have been significant increases in drug costs over the past ten years. Medication shortages, new specialty therapies, and FDA drug approvals are some of the primary factors for the rise in hospital medication expenditures.

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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.

Roots Analysis

MARCH 11, 2022

Exosomes have been of great interest in the recent years due to the discovery of their potential in so many research and analytic procedures. Exosomes are known to have some unique functions, such as their ability to alter recipient cell bioactivities, acting like intercellular messengers and also having therapeutic potential in disease diagnostics as well as targeted drug delivery.

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pharmaphorum

MARCH 11, 2022

AbbVie’s longstanding alliance with Hungarian drugmaker Gedeon Richter has already given it one blockbuster medicine – Vraylar for schizophrenia and bipolar disorder – and the two partners have just decided to extend their working relationship. They have just signed a new co-development and license agreement focusing on novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases, covering several new chemical entities (NCEs) that have already been selected f

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Labelling 52

pharmaphorum

MARCH 11, 2022

AbbVie’s Qulipta has become the first oral drug in the CGRP inhibitor class to show efficacy in chronic migraine prevention in a pivotal trial, setting it up for a role in a category currently dominated by injectable therapies. The phase 3 PROGRESS trial showed that taking Qulipta (atogepant) every day – ether in a once-daily or twice-daily dose – reduced the number of days with migraine patients experienced per month compared to placebo.

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Labelling FDA 52

Pharma Mirror

MARCH 11, 2022

Digital meetings driving international partnering at CPhI Japan as companies search for ingredients suppliers Tokyo: CPhI Japan 2022 returns as a SMART event – with live exhibition at the Big Sight Exhibition Center in Tokyo (20-22 April) alongside an online networking platform – as CPhI data[1] confirms the country continues to top global ‘API quality’ rankings, with Japanese respondents bullish on growth in 2022 forecasting a CAGR of 14% on average.

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Pharma Times

MARCH 11, 2022

93% of people suspected by GPs to have cancer should be seen by a specialist within two weeks but this has fallen to just 75%

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Pharma Mirror

MARCH 11, 2022

Casimir Further Differentiates Emmes’ Industry-Leading Rare Disease Research Capabilities Rockville, MD, March 10, 2022 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Casimir, a U.S.-based CRO. Casimir has experience in more than 20 rare diseases and has worked with regulators, sponsors and patients to develop outcome measures that capture the nuan

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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

Pharma Times

MARCH 11, 2022

Treatment demonstrated a good safety profile in the overall patient population during the 12-week induction phase

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Pharma Mirror

MARCH 11, 2022

The healthcare professions are rewarding, stimulating, prestigious, and lucrative. Few other professionals can say that their daily task is to save lives. The post Common Risks of Working as a Healthcare Professional appeared first on Pharma Mirror Magazine.

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pharmaphorum

MARCH 11, 2022

After a period where vaccine development had fallen away, suddenly it is back in the limelight. Investment has flowed back into the sector and Ben Hargreaves finds how this is changing the infectious disease pipeline, as well as how the industry is seeking to address weaknesses in manufacturing capacity. There are very few things to be grateful for about the arrival of the pandemic.

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pharmaphorum

MARCH 11, 2022

From 1 April, it will be no longer be possible for most people in England to get access to free COVID-19 lateral flow tests (LFTs) or PCR testing, and companies are racing to tap into the new commercial opportunity. One such is Everything Genetic, which has just claimed regulatory approval for its £1.99 COVID antigen assay, claimed to offer a clinical performance of 96.1% sensitivity and 100% specificity.

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Immunization 59

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