Wed.Sep 13, 2023

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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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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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Moderna looks to scale back manufacturing for COVID booster to cope with falling demand: Reuters

Fierce Pharma

While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.

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

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Moderna CEO expects endemic COVID vaccine market will take ‘a few years’ to fully develop

Fierce Pharma

Moderna has spent the last several years riding the ups and downs of the COVID-19 pandemic. | Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response.

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The Gigification of Healthcare

MedCity News

By leveraging technology and strategies used within the gig economy—and even tapping into the talent pool of gig workers themselves—healthcare organizations can address staffing shortages, retain and motivate more workers, and ultimately deliver better patient care.

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What CVS Stands to Gain by Setting Up Biosimilar Subsidiary Cordavis

MedCity News

Pharmaceutical industry observers say CVS Health’s creation of Cordavis, a new biosimilar drugs company, is part of a strategy to make its move into this market as profitable as possible.

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Despite FDA doubts, Alnylam wins expert backing for Onpattro expansion into rare heart disease

Fierce Pharma

After Alnylam faced FDA doubts about its bid to expand RNA-silencing drug Onpattro into a rare heart disease called transthyretin amyloidosis cardiomyopathy (ATTR-CM), the company has picked up key | An FDA advisory committed voted in favor of Alnylam's bid to expand its RNA-silencing drug Onpattro into the rare heart disease called ATTR-CM. But comments at Wednesday’s panel suggest the drug could carry a disadvantage in its upcoming clash with Pfizer.

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Medicare Startup Prioritizing ‘Movement As Medicine’ Snags $17M

MedCity News

Bold, a Los Angeles-based company offering a healthy aging platform for older adults, closed a $17 million Series A funding round. The startup seeks to improve the health of Medicare Advantage beneficiaries through personalized exercise programs designed to prevent falls, decrease musculoskeletal pain and boost physical activity levels.

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England's NICE backs Pfizer's Vydura as treatment for acute migraines

Fierce Pharma

Less than four months after recommending Pfizer’s Vydura (rimegepant) to prevent m | Less than four months after recommending Pfizer’s Vydura (rimegepant) to prevent migraine headaches, England’s National Institute of Care and Health Excellence (NICE) has given it a thumbs up to treat them. With the nod, approximately 13,000 patients will have access to the first treatment approved in the U.K. for episodic (acute) migraine attacks.

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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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The problem with clinical trials (and how virtual insight-gathering can help)

Impetus Digital

A version of this article was previously published in the Journal of mHealth. These days, clinical trials are in the news pretty much daily. Whether successful or not, they can impact not only the perception of a pharmaceutical company but also their stock prices. While still the gold standard of research, clinical trials are often riddled with issues that limit their applicability to broader populations or delay market access.

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Site Enablement: How Sponsors and CROs Can Enhance Their Clinical Trials in a Competitive Landscape

Fierce Pharma

The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to Pr | Effective site enablement must address several factors, including protocol design, training, patient recruitment and enrollment, and more.

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UK ATMP facility granted cGMP approval

European Pharmaceutical Review

Following a UK Medicines & Healthcare Products Regulatory Agency (MHRA) inspection, Rentschler Biopharma SE’s UK advanced therapy medicinal products (ATMP) facility has received a current good manufacturing practice (cGMP) Manufacturing Compliance Certificate. This means that the contract development and manufacturing organisation (CDMO)’s site in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, is compliant to produce adeno-associated virus (AAV) vectors fo

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FDA to start review of subcutaneous Entyvio for Crohn’s disease

Pharmaceutical Technology

The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Eisai launches new digital business company for dementia

PharmaTimes

Theoria technologies aims to empower those affected by dementia - News - PharmaTimes

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Eli Lilly’s Mounjaro approved on NHS for use in type 2 diabetes

Pharmaceutical Technology

Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).

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ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility

Pharmaceutical Commerce

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

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UKRI’s MRC invests £2m for hard-to-treat cancers

PharmaTimes

Four research innovation teams are set to receive £500,000 each - News - PharmaTimes

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Clarify at SHSMD Connections 2023: Case studies on using market and patient insights to accelerate strategic growth

Clarify Health

In September of 2023, marketing and strategy leaders from around the country gathered at the Society for Health Care Strategy & Market Development’s (SHSMD) annual conference in Chicago, IL. Clarify was excited to attend the conference and meet with these leaders to discuss health system growth strategies and provide real world insights during an interactive speaking session.

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Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Legacy MEDSearch

Inspira Technologies OXY BHN Ltd. (Nasdaq: IINN , IINNW) (the “Company” or “Inspira Technologies”), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device, to the U.S. Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024.

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Rentschler Biopharma ATMP Facility Receives MHRA Approval

PharmaTech

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

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Helping Hands: How Top Salespeople Really Operate

Contrarian Sales Techniques

More Than Just a Sale You know that friend who’s always there when you need advice? Imagine if shopping felt like that - a helpful nudge in the right direction rather than someone pushing stuff on you. That's the magic some salespeople bring to the table. I've come to realize that the best salespeople don't really 'sell'. Instead, they're like your shopping buddy, guiding you to make the best choice.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Recipharm Partners with Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy

PharmaTech

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

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Women’s Health Landscape and New Treatment Approaches on the Horizon

PharmExec

As the industry expands on areas of women’s health with large unmet medical needs, one biotech company is targeting local, vaginal inflammation, specifically for women undergoing IVF and to address other fertility- and reproductive tract-associated health conditions.

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Nurix Announces Strategic Collaboration with Seagen

PharmaTech

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

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Results from Rybrevant trial solidify Janssen’s foothold in EGFR-mutated NSCLC

Pharmaceutical Technology

Currently, NSCLC patients with EGFR exon 19 deletions or L858R substitution face limited therapeutic options after seeing disease progression post-front-line treatment.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Frontiers Adopts CCC Ringgold Identify Database

Copyright Clearance Center

The post Frontiers Adopts CCC Ringgold Identify Database appeared first on Copyright Clearance Center.

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Vaxess raises $9m to accelerate mRNA vaccine patch development

Pharmaceutical Technology

The patch allows for vaccine storage and transport at room temperature along with at-home administration.

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CDC’s ACIP Votes in Favor of Universal Recommendation for 2023-2024 Monovalent COVID-19 Vaccines

Pharmacy Times

The CDC emphasized the need for protein-based vaccine options in endorsing a vote by the Advisory Committee on Immunization Practices for the universal recommendation of the 2023-2024 monovalent, XBB containing COVID-19 vaccines.

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Avalo drops three rare disease assets amid ongoing challenges

Pharmaceutical Technology

The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.