Sat.Sep 09, 2023 - Fri.Sep 15, 2023

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Avoiding Commercialization Pitfalls for CGTs

PharmExec

Lung-I Cheng, vice president of cell and gene therapy (CGT), Cencora (formerly AmerisourceBergen), discusses CGT commercialization strategies, common knowledge gaps, and what he wishes companies knew about commercialization strategies.

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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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How Meditech Plans to Integrate Google’s Generative AI Into Its EHR

MedCity News

Over the past year, Meditech has deepened its relationship with Google Cloud by exploring ways to embed Google’s generative AI into its EHR. Some of the use cases the EHR vendor is exploring include an enhanced search and summarization tool that would present clinicians with a longitudinal view of their patient and a tool that would generate predictive summaries of what a patient’s stay might look like at the time of admission.

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Developing an effective contamination control strategy

European Pharmaceutical Review

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

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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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Frontiers Adopts CCC Ringgold Identify Database as its PID Solution

Copyright Clearance Center

September 12, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced Gold Open Access (OA) publisher Frontiers has adopted the industry-leading Ringgold Identify Database as its Persistent Identifier (PID) solution to help power its OA models by normalizing and disambiguating organization data.

Leads 116
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It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

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Small molecule drug shows promise in rare disease

European Pharmaceutical Review

The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance. Dercum’s disease is characterised by painful lipomas developing primarily on the trunk in the body. Currently there are no approved or effective medicine, so the data from the Phase II study shows potential of a treatment for this indication.

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Organoids Produce Tooth Enamel Proteins

Medgadget

Researchers at the University of Washington School of Medicine have developed a method to create stem cell-derived organoids that can produce tooth enamel proteins. The breakthrough could pave the way for lab grown enamel that can be used in dental repairs and may even allow for living fillings or completely new living teeth that can be implanted into a patient’s jaw.

Medicine 106
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CDC starts ‘Wild to Mild’ campaign to reverse falling flu vaccine use in key groups

Fierce Pharma

The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.

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Most Hospitals Are Still Violating HIPAA By Using Web Tracking Tools, Despite Federal Warnings

MedCity News

The federal government has warned hospitals that using third-party analytics tools on their websites could violate HIPAA, and more than 20 hospitals are facing class-action lawsuits over the use of these tools. But a recent analysis found that hospitals are doing a poor job of fixing their websites and preventing patient data collection.

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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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CPHI Pharma Awards 2023 finalists announced

European Pharmaceutical Review

For its 20 th anniversary, more than 180 entries across 12 categories have been narrowed down to determine the finalists the upcoming CPHI Pharma Awards. To recognise the influx of innovation across the pharmaceutical industry, three new categories are included in this year’s awards. The shortlisted finalists of the CPHI awards for 2023 include companies that led by example in sustainable manufacturing, manufacturers and innovators that developed new technologies to advance drug discovery, devel

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Digital Medicine in Pharma: A Marketers’ Guide for Launch, Promotion and Life Cycle Management

Eversana Intouch

Digital medicine is emerging as a revolutionary field that can transform the entire spectrum of healthcare, from proactive prevention to effective treatment of diverse medical conditions. Unlike traditional pharmaceutical medications, digital medicine products need to speak to the clinical, economic and technological benefits to differentiate themselves from competitors.

Medicine 105
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J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

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Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff

MedCity News

This week, senators introduced a bipartisan bill that would make it a federal crime to assault hospital workers. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital employees from assault or intimidation.

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

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AstraZeneca partnership to pioneer UK’s first commercial biomethane supply

European Pharmaceutical Review

Under a new agreement, AstraZeneca is set to establish the first unsubsidised industrial-scale supply of biomethane. The pharmaceutical firm is investing greatly in its existing infrastructure to facilitate the shift to renewable gas and support a transition to 100 percent renewable energy. This includes its Macclesfield campus, the UK’s largest pharma manufacturing site.

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Signal: Kroger to pay up to $1.4bn to settle opioid crisis lawsuits

Pharmaceutical Technology

Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.

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Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

Fierce Pharma

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. | Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances.

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Generative AI, RPM Were Among the Biggest Trends In Health IT Fundraising During Q2

MedCity News

Healthcare IT companies raised $1 billion in venture capital in Q2 — down slightly from the $1.3 billion raised in Q1 but up significantly from the $451.3 million raised in Q4 2022. Unsurprisingly, a lot of these investments were made in companies offering generative AI products. Another key trend was increasing cash flow to remote patient monitoring startups, likely caused by expanded reimbursement for these services.

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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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Pfizer’s migraine medicine recommended by NICE

European Pharmaceutical Review

Rimegepant (Vydura) is the “first and only NICE-recommended medicine that can help alleviate the misery of acute migraines, and may be considered a step-change in treatment,” shared Helen Knight, Director of medicines evaluation at the National Institute for Health and Care Excellence (NICE). Made by Pfizer, Rimegepant (Vydura), is recommended in NICE final draft guidance for adults who have tried at least two triptans but failed to achieve adequate relief with these medicines.

Medicine 105
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Brain Computer Interface Decodes Speech and Facial Expressions

Medgadget

Researchers at the University of California San Francisco have developed a brain computer interface that can lets someone with severe paralysis communicate with both speech and facial expressions, in the form of a digital avatar. The breakthrough advances what has been possible, with previous brain computer interface systems providing speech only, and allows people to communicate more completely, encompassing facial expressions, which are an important aspect of natural communication.

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AstraZeneca, working to grow Fasenra’s reach, touts positive trial against GSK's Nucala in new use

Fierce Pharma

Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.

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Moderna Puts Up $120M to Start Cancer Drug R&D Alliance With Immatics

MedCity News

Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.

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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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Implementing the future of mRNA therapeutics

European Pharmaceutical Review

The next generation of therapeutics has arrived: from simple design and development to theoretically unlimited targets, messenger RNA ( mRNA )‑based therapeutics offer a multitude of benefits. However, creating these innovative treatments harbours challenges. This article explores common developmental and design issues and how to mitigate difficulties before they occur.

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Fortifying Defenses Pre-Patent Cliff

PharmExec

Integrating artificial intelligence and advanced analytics throughout operations offers pharma companies a pathway to offset impending drug patent expirations.

Pharma 105
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Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Fierce Pharma

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophreni | Lyndra Therapeutics is laying off staff two months after a CEO swap and as interim data from a pivotal trial for a schizophrenia drug nears. The company's lead asset is a long-acting, oral version of Johnson & Johnson's Uzedy.

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How 4 Mental Health Firms Want the DEA to Handle Virtual Prescribing of Controlled Substances

MedCity News

Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health sent a letter to the DEA asking for a special registration process that would allow for the prescribing of certain controlled medications via telemedicine.

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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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AI to revolutionise drug development by 2026

European Pharmaceutical Review

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Data predicted that in 2030, more than half of US Food and Drug Administration (FDA)-approved drugs will involve AI in their development and/or manufacturing.

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Microneedle Skin Patch Measures Cancer Biomarkers

Medgadget

Researchers at the Harvard Wyss Institute have developed a technique that lets clinicians to characterize and monitor melanoma. The system involves using a microneedle patch that can draw deep interstitial fluid into itself through a series of penetrating hyaluronic acid needles. The needles can later be dissolved to release the biomarkers into a test tube before analysis, using a highly sensitive technique called Simoa, to detect individual biomarker protein molecules.

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FDA raises questions about Onpattro's efficacy in Alnylam's bid to challenge Pfizer in lucrative heart disease use

Fierce Pharma

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).

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Solera Health Launches Weight Management Solution for Payers and Employers

MedCity News

Solera Health recently launched a program that aims to help patients who are interested in GLP-1s gain access to lifestyle change support. It also provides educational materials on GLP-1s.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time