Sat.Apr 01, 2023 - Fri.Apr 07, 2023

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J&J opens its wallet with whopping $8.9B talc settlement offer

Fierce Pharma

J&J opens its wallet with whopping $8.

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Pfizer escapes proposed class action lawsuit over patient copay assistance

Fierce Pharma

Pfizer escapes proposed class action lawsuit over patient copay assistance esagonowsky Thu, 04/06/2023 - 11:03

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Must know facts about Video marketing in Healthcare

eMediWrite

Different types of video media are used in video marketing to advertise and market the goods and services offered by healthcare companies. An astounding 86% of healthcare companies use video marketing as a marketing strategy. The effectiveness of video as a marketing tool is also attributed to its extremely shareable nature. It tries to draw in and educate audiences, hold their attention, and turn them into customers.

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Eli Lilly Invests Heavily in Debut Mounjaro TV Ad Campaign for Diabetes

PharmExec

Eli Lilly debuts its first Mounjaro TV commercial amid high demand for the diabetes injection, which also shows promise in weight loss applications and outperformed rivals Ozempic and Wegovy in clinical trials.

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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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3 Tech Adoption Rules for Health Systems to Follow

MedCity News

Hospitals are being more careful than ever when scrutinizing ROI for new technology. Ashis Barad — Allegheny Health Network’s chief information and digital officer — gave advice for health systems follow during the adoption process for new technology, such as ensuring clinicians are involved early on and viewing Big Tech as partners instead of threats.

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After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits

Fierce Pharma

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44

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Eculizumab biosimilar gets positive CHMP opinion

European Pharmaceutical Review

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. EPYSQLI [has become]… our first biosimilar in haematology to be recommended for approval in Europe” EPYSQLI has been recommended for approval in patients with paroxysmal nocturnal hemoglobinuria (PNH).

Medicine 105
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Op-Ed: CMS Should Fine 30% of Hospitals It has Found to Be Violating Federal Price Transparency Law

MedCity News

As a first step to move toward greater hospital price transparency and lower costs, CMS can immediately issue $2 million fines on the 30% of American hospitals it concludes are noncompliant. If CMS takes enforcement seriously, the hospital industry will respond by quickly coming into compliance.

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COVID-19 patent fights continue as Arbutus, Genevant come after Pfizer and BioNTech in new lawsuit

Fierce Pharma

COVID-19 patent fights continue as Arbutus, Genevant come after Pfizer and BioNTech in new lawsuit zbecker Tue, 04/04/2023 - 11:01

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Enanta secures FDA fast track designation for EDP-323 to treat RSV

Pharmaceutical Technology

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

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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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New Strategies for the Now Everywhere Point of Care

PM360

The idea of what constitutes the “point of care” is evolving. At its heart, the point of care has always revolved around the when and where patients are making decisions about their health. Often, these moments are happening in the presence of their healthcare provider (HCP), especially in-person at doctor’s offices. But now patients can also see an HCP via telehealth or chat with them through an online patient portal.

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The Next Generation of Healthcare Payments: Convenient, Seamless, Simple

MedCity News

By supporting next-generation payment methods that boost security and convenience for consumers, providers can enhance patient satisfaction and loyalty.

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FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss

Fierce Pharma

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss aliu Tue, 04/04/2023 - 16:48

FDA 278
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MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease

Pharmaceutical Technology

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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

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How Essentials Research Supported Established Brand with Agile Syndicated Tracking

InCrowd

A well-known, established blockbuster brand at a top-10 pharma company needed a better solution for tracking its highly competitive market. Their traditional, data-heavy, time-consuming, and expensive ATU wasn’t meeting their needs. Learn how Essentials, InCrowd’s syndicated tracking solution, helped them collect competitive intelligence, save budgetary dollars, and eliminate their large ATU, allowing for more time and attention to the market events.

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3 Critical Levers for Reimagining Patient Flow and Improving Care Orchestration

MedCity News

By more precisely improving care orchestration by reimagining patient flow across disparate care settings, health systems can improve demand, capacity, and throughput challenges.

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After rumored merger fell through, Merck and Seagen's Padcev-Keytruda combo wins bladder cancer nod

Fierce Pharma

After rumored merger fell through, Merck and Seagen's Padcev-Keytruda combo wins bladder cancer nod fkansteiner Mon, 04/03/2023 - 18:10

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EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa.

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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 Importance of Semantic Search Capabilities for Life Sciences Orgs

Copyright Clearance Center

The following is an excerpt from Accessing and Analyzing Relevant Content in Today’s Information Chaos.   Semantic enrichment is the ingredient behind getting relevant search results even if they don’t use the same terminology as the query. For example, a query for “rare disease drug approval” would include results for the Orphan Drug Act from the FDA.

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Inato Snags $20M to Make Clinical Trials More Diverse & Accessible

MedCity News

Inato recently raised $20 million in Series A2 funding for its tech platform, which enables access to inclusive clinical trials. The two-way platform brings exposure to community-based providers who often are overlooked by Big Pharma for clinical trial sites by allowing providers to apply for clinical trials in which they’re interested.

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Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims

Fierce Pharma

Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims zbecker Thu, 04/06/2023 - 11:40

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Vertex and CRISPR Therapeutics submit BLAs to FDA for exa-cel

Pharmaceutical Technology

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The applications include requests for priority review. If granted, these would shorten the time taken for application review to eight months.

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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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Sustained-release chemotherapy has potential for bladder cancer

European Pharmaceutical Review

A new, sustained-release chemotherapy delivery device inserted into the bladder, facilitated tumour response, a study has reported. The treatment was given to elderly patients with advanced bladder cancer who were medically unfit for standard treatment. The intravesical device, TAR-200, provides continuous, low-dose, local delivery of gemcitabine chemotherapy. “TAR-200 was generally safe, well tolerated, and had beneficial effects on bladder cancer outcomes,” commented lead author Dr

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Why Sofinnova is Betting on the Confluence of Digital Technology and the Life Sciences

MedCity News

Paris-based Sofinnova Partners announced last week that it has launched a new strategy aimed at investing in a new breed of startups that straddle the lines between data and biology.

Biopharma 114
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Pfizer moves on up to the West Side, establishing new nerve center at Hudson Yards' Spiral skyscraper

Fierce Pharma

Pfizer moves on up to the West Side, establishing new nerve center at Hudson Yards' Spiral skyscraper fkansteiner Tue, 04/04/2023 - 11:42

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Alzheimer’s disease not forgotten as FDA oversees record number of designations awarded

Pharmaceutical Technology

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. This coincided with the much-anticipated wave of monoclonal antibody drugs for Alzheimer’s disease (AD) such as Eisai/Biogen’s Leqembi (lecanemab-irmb) and Eli Lilly’s donanemab, which are predicted to provide significant improvement on previous AD therapies.

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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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Could reducing agar concentration enhance microbial growth?

European Pharmaceutical Review

The pour plate method is used for microbiological control of pharmaceutical products and enumeration of microorganisms with low microbiological limits. Separating the agar from the other components of commonly used media during sterilisation and reducing the agar concentration to 10g/L can enhance microbial growth, a study has shown. Technological advances have allowed the development of rapid analytical techniques such as PCR or enzyme-linked immunosorbent assay (ELISA).

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Regulatory Roundup: Narcan’s Nod, an ALS Adcomm, FDA Holds Lifted & More

MedCity News

Narcan, a nasal spray product that reverses the effects of opioid overdose, is now FDA approved for non-prescription use. Other recent FDA approvals include decisions for drugs from Pharming Group, Incyte, and Aurion Biotech.

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AstraZeneca says Lynparza, Imfinzi combo excels in first look at ovarian cancer trial

Fierce Pharma

AstraZeneca says Lynparza, Imfinzi combo excels in first look at ovarian cancer trial kdunleavy Wed, 04/05/2023 - 10:46

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Sartorius upscales gene therapy prowess with $2.6bn Polyplus acquisition

Pharmaceutical Technology

Sartorius , through its French listed sub-group Sartorius Stedim Biotech , has signed an agreement to acquire Polyplus for €2.4bn ($2.6bn). The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. Polyplus, based in Strasbourg, France, produces key components in the production of viral vectors used in cell and gene therapies.

Media 98
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time