Sat.Mar 04, 2023 - Fri.Mar 10, 2023

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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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Trending Sources

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Mapping the path to future changes in the Journal Citation Reports

Clarivate

In July 2022, I shared our plans to extend the Journal Impact Factor (JIF) to all journals in the Web of Science Core Collection from June 2023. This means that this year, journals from the Arts and Humanities Citation Index (AHCI) and the multidisciplinary Emerging Sources Citation Index (ESCI) in the Journal Citation Reports (JCR) will receive a JIF for the first time.

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Cybersecurity in the Connected Medical Future

MedCity News

The healthcare industry of the future will be defined by interoperable systems that need to securely share critical data across devices, distributed applications, and networks.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva

Fierce Pharma

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

FDA 280
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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

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3 Keys to Better Cybersecurity

MedCity News

As companies review their processes, below are three approaches they can keep top of mind — namely, increasing employee training and utilizing technology as safeguards, making a point to learn and change processes following attacks, and prioritizing vetting partners’ security.

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'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

Fierce Pharma

'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines tcarey Thu, 03/09/2023 - 15:25

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New cell therapy company will treat solid tumours

European Pharmaceutical Review

The joining of Adaptimmune Therapeutics and TCR² Therapeutics will form a new cell therapy company focused on treating solid tumours. Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer asserted that the combined companies will work to gain “approval for the first engineered T-cell receptor (TCR) T-cell therapy for a solid tumour – afami-cel for the treatment of synovial sarcoma.

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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Elevance Health: Long Covid Patients Are at Increased Risk for Cardiovascular Problems, Mortality

MedCity News

A recent Elevance Health study found that long Covid patients are 2.35 times more likely to experience cardiac arrhythmia and 3.64 times more likely to experience pulmonary embolism. The study also discovered higher mortality rates among long Covid patients.

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Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy

Fierce Pharma

Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy aliu Thu, 03/09/2023 - 17:22

FDA 274
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Could default eligibility improve clinical trial enrolment?

European Pharmaceutical Review

A new approach developed at the Medical University of South Carolina (MUSC) aiming to improve clinical trial eligibility has shown positive results. The South Carolina Clinical & Translational Research (SCTR) Institute’s patient outreach recruitment (POR) team and partners made potential patients eligible by default. This enabled them to learn of clinical trials in which they could participate.

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Consumerism, Customer Experience at Healthcare’s Forefront

MedCity News

Healthcare consumerism and prioritizing the customer experience to boost loyalty are key focus areas for providers and payers in the months and years ahead.

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Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members

Fierce Pharma

Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members kdunleavy Tue, 03/07/2023 - 09:41

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Temperature-stable tuberculosis vaccine induces immune response

European Pharmaceutical Review

The first clinical trial of any subunit tuberculosis (TB) vaccine in a temperature-stable form has found that ID93+GLA-SE, a freeze-dried vaccine, was safe. Investigators assessed whether administering a temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection.

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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Cerebral Admits That it Wrongly Shared Data of 3.1M Users

MedCity News

Cerebral recently notified 3.1 million of its users that their private health information was shared with tech companies like Meta, Google and TikTok. The data breach stemmed from Cerebral’s use of pixel tracking technology, which the company said has been discontinued or reconfigured.

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AbbVie CEO Gonzalez scored $26M in 2022 pay as cash cow Humira neared patent cliff

Fierce Pharma

AbbVie CEO Gonzalez scored $26M in 2022 pay as cash cow Humira neared patent cliff aliu Tue, 03/07/2023 - 10:54

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An Inside Look at Pharma Revenue Management

PharmExec

According to the 2023 State of Revenue Report, pharma companies are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

Pharma 105
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Enhancing bioavailability in ocular drug delivery

European Pharmaceutical Review

A review by researchers on ocular drug delivery discussed strategies that could enhance ocular bioavailability. Currently, effective topical administration is challenging as the industry aims to prolong drug residence time and guarantee appropriate ocular permeation. Although many potent drugs are available to treat most ocular complaints, there are barriers such as tear film, corneal and conjunctival.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Gen Z-Focused Mental Health Platform Founded by Stanford Psychologist Raises $6M

MedCity News

Wave Life — a mental health platform designed for Gen Z — recently closed a $6 million seed investment led by Santé Ventures. The company — which was founded by Sarah Adler, a clinical psychologist and clinical associate professor at Stanford’s psychiatry department — will use the funding to move further into the employer market and conduct research on its care model’s outcomes.

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Sanofi's site modernization spree rolls on with plan to shift 2,000 staffers to new flexible workspace in New Jersey

Fierce Pharma

Sanofi's site modernization spree rolls on with plan to shift 2,000 staffers to new flexible workspace in New Jersey fkansteiner Tue, 03/07/2023 - 10:50

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Congress Probes PBM Link to Higher Drug Prices

PharmExec

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Zocdoc Partners With Zaya Care for Pregnancy, Postpartum Services

MedCity News

Through the partnership, patients can find and book appointments with Zaya’s providers via Zocdoc’s website or app. The partnership represents the first time Zocdoc will have lactation consultants available on its marketplace, said Dr. Oliver Kharraz, Zocdoc founder and CEO.

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In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud

Fierce Pharma

In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud fkansteiner Thu, 03/09/2023 - 08:45

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

Highly potent active pharmaceutical ingredients (HPAPIs) are used in formulations for high potent drugs, owing to their ability to target precise disease cells including cancer cells. 1 These substances “are pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained.

Safety 98
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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time