pharmaphorum

DECEMBER 22, 2021

A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic. The PandemicX accelerator, launched by the Department of Health and Human Services, is focused on “using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.” Companies that have been invited to take part will get “curriculum, mentor

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Vaccines 115

Fierce Healthcare

DECEMBER 22, 2021

13.6M have signed up for coverage on ACA exchanges during open enrollment so far: CMS. pminemyer. Wed, 12/22/2021 - 11:41.

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Outsourcing Pharma

DECEMBER 22, 2021

It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.

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pharmaphorum

DECEMBER 22, 2021

Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. However, we have seen a framework of guidelines and recommendations during the last year on everything from increasing diversity to producing lay summaries, start to take shape. As part of our 2021 in Review series, we look back over some of these developments.

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Documentation 105

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.

Fierce Healthcare

DECEMBER 22, 2021

Duke University accused of 'conspiring' to take over independent physician practice. dmuoio. Wed, 12/22/2021 - 12:19.

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pharmaphorum

DECEMBER 22, 2021

Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. Just a few weeks France’s Sanofi made a $40 million investment in Gyroscope for first refusal rights on the gene therapy – called GT005 – but it is Novartis that has swooped on the company and its main asset.

Immunization 101

Immunization FDA 101

pharmaphorum

DECEMBER 22, 2021

The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA an outlier in its stance on the drug. An advisory committee to the Ministry of Health, Labour and Welfare (MHLW) has declined to approve Aduhelm (aducanumab), saying the data from its two main clinical trials is hard to interpret, and is seeking additional data.

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FDA 96

Fierce Healthcare

DECEMBER 22, 2021

Industry Voices—Using your health plan to achieve your New Year's resolutions. pminemyer. Wed, 12/22/2021 - 10:00.

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pharmaphorum

DECEMBER 22, 2021

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The agency has cleared Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of the severity of their symptoms, making it an option for an estimated eight million people with the skin disorder in the US.

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Labelling FDA 59

Policy Prescription

DECEMBER 22, 2021

UPDATE : Senator Amy Klobuchar (D-MN) has withdrawn her sponsorship and support for this bill. A new bill introduced by Sens. Mark Rubio (R-FL) and Amy Klobuchar (D-MN) , called the “Domain Reform for Unlawful Drug Sellers Act’’ or, for short, the ‘‘DRUGS Act,’’ could effectively end online access to safe and affordable imported medicines for Americans.

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FDA 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

pharmaphorum

DECEMBER 22, 2021

Pfizer has called a halt to a clinical trial of its gene therapy for Duchenne muscular dystrophy as it investigates the unexpected death of a young male patient. In an update posted today the pharma giant said “we do not yet have complete information and are actively working with the trial site investigator to understand what happened.” In the meantime, it is pausing screening and dosing of the fordadistrogene movaparvovec (PF-06939926) gene therapy, and working with the trial’

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FDA 59

Fierce Healthcare

DECEMBER 22, 2021

Editor's corner: Fierce Health IT's 10 most read stories of 2021 tracked Google, Amazon and the investment boom. hlandi. Wed, 12/22/2021 - 13:56.

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pharmaphorum

DECEMBER 22, 2021

Creating certainty in a landscape still convulsed by the pandemic is a lofty ambition, but pharma companies can use the disruption to develop positive internal change, as well as shoring up sales. While industry has variable influence over the reshaping of contacts with clinicians who have latched onto the benefits of telemedicine and virtual meetings, it has total control of how it structures and conducts its business.

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Communication 52

Fierce Healthcare

DECEMBER 22, 2021

California will soon require healthcare workers to receive a COVID-19 booster, Newsom announces. dmuoio. Wed, 12/22/2021 - 10:44.

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Pharmacy Management Software

pharmaphorum

DECEMBER 22, 2021

Japanese drugmaker Takeda has suffered a blow to its late-stage pipeline, after the FDA rejected its marketing application for TAK-721, a drug candidate that is trying to be the first approved therapy in the US for eosinophilic oesophagitis (EoE). Takeda said it had received a complete response letter from the US regulator that is asking for another clinical trial of the drug, which could set back the timeline for the programme considerably.

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Fierce Healthcare

DECEMBER 22, 2021

Editor's corner: Fierce Healthcare's 10 most read stories tracked COVID, vax mandates and megadeals. hlandi. Wed, 12/22/2021 - 11:54.

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Pharma Times

DECEMBER 22, 2021

Calls for booster vaccinations in order to combat the rising cases brought about by winter and the recent Omicron variant have intensified, in the midst of record case rates.

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Vaccines 49

Med Ed 101

DECEMBER 22, 2021

Tricyclic antidepressants are still used in clinical practice. Their use has diminished over time as newer and generally safer medications have been invented, but you will see them occasionally. In my primarily geriatric practice, I would say that I see them a couple of times per week. I will outline some of the most important […]. The post Tricyclic Antidepressant Clinical Pearls appeared first on Med Ed 101.

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Pharma Times

DECEMBER 22, 2021

With authorisation, Pfizer’s oral antiviral candidate Paxlovid is an investigational SARS-CoV-2 protease inhibitor could be prescribed at the first sign of COVID-19 infection.

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Fierce Healthcare

DECEMBER 22, 2021

Editor's corner: Fierce Health Payer's top 10 stories of 2021. pminemyer. Wed, 12/22/2021 - 13:40.

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pharmaphorum

DECEMBER 22, 2021

For the past ten years we’ve seen a steady acceptance of the need for patient engagement practises to become routine and integrated into all systems of healthcare and the creation of new medicines and devices. The milestones of patient engagement are illustrated in figure 1. However, 2021 has been different. This may be due to the impact of the global pandemic promulgating companies and patient groups into finalising the practicalities of patient engagement from a ‘nice to’ to ‘must do’.

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Roots Analysis

DECEMBER 22, 2021

Classification of Regulatory T-Cell Therapies. The Regulatory T-Cell Therapies (Tregs) are a mature subpopulation of T-cells that play a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. These mainly develop in thymus from CD4 + thymocytes and are mainly of three types: natural Tregs, adaptive Tregs and invitro Tregs.

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Immunization 52