Tue.Mar 21, 2023

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Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma

Fierce Pharma

Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma fkansteiner Tue, 03/21/2023 - 11:14

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Nvidia, Medtronic Partner to Create AI Platform for Medical Devices

MedCity News

Nvidia and Medtronic recently announced a collaboration focused on embedding AI into medical devices. The two companies plan to create marketplace for AI applications that will allow developers and clinicians to develop their own algorithms to use on Medtronic’s medical devices.

Medical 117
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Trending Sources

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Biopharma industry lobbies for tax breaks related to US-based manufacturing

Fierce Pharma

Biopharma industry lobbies for tax breaks related to US-based manufacturing kdunleavy Tue, 03/21/2023 - 11:14

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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

Safety 115
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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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As approvals roll in, Takeda details pricing strategy for dengue vaccine launch

Fierce Pharma

As approvals roll in, Takeda details pricing strategy for dengue vaccine launch zbecker Tue, 03/21/2023 - 10:40

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‘The Stakes Couldn’t Be Higher’: How DEA’s Proposal Will Affect Telehealth Controlled Substance Prescribing

MedCity News

The DEA recently released proposed rules that would require an in-person visit before a patient can receive a telehealth prescription for a controlled substance. The DEA touts the change as a way to ensure patient safety, but several telehealth advocates argue it will greatly disrupt access for those who need the drugs — especially at a time when the mental health and substance use crisis is growing.

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Pharmacists Are Essential to Rural Access to Healthcare

MedCity News

Tapping into community pharmacy can bring water to these rural healthcare deserts. Studies show that nine in ten Americans live within five miles of a pharmacy and high-risk patients visited their community pharmacy an average of 35 times per year, compared to four visits to their primary care provider and nine visits to specialists.

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Merck, Viatris close in on settlement in long-running Januvia patent case

Fierce Pharma

Merck, Viatris close in on settlement in long-running Januvia patent case esagonowsky Tue, 03/21/2023 - 08:30

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Employee Spotlight: Rob Moore

InCrowd

Rob Moore the Director of Information Technology for Apollo Intelligence. Get to know more about him below! Tell us about your role: I’m the Director of Information Technology for Apollo Intelligence. Apollo Intelligence supports market insights brands in the life science space. I’m responsible for managing IT infrastructure (on-prem) and in the cloud (Azure Advice Directory) along with establishing and administering security measures within the organization and overall strategies and proc

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Allermi Raises $3.5M in Seed Funding To Grow DTC Allergy Relief Platform

MedCity News

Allermi’s $3.5 million seed funding was led by Nelstone Ventures and included participation from FourSight Capital Partners. The company will use the money to expand nationally.

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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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Biomimetic Construct Models Burn Injuries

Medgadget

Researchers at Harvard University have developed a model of burn injuries that will allow them to investigate the mechanisms underlying healing in such injuries and test out new approaches to enhance this process. Burns can take a long time to heal and can be prone to infection and complicated by the presence of large quantities of dead tissue at the injury site.

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“Culling of the Herd”: How One CEO Believes SVB’s Failure May Accelerate M&A in Healthtech

MedCity News

Included Health CEO Owen Tripp believes that the sudden demise of Silicon Valley Bank may actually lead to a “culling of the herd” as healthtech companies yet to prove their value will stop functioning as standalone companies or get bought by larger companies with stable revenue and a proven business model.

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MHRA approves prostate cancer combination therapy

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combination therapy with abiraterone and prednisone or prednisolone. AstraZeneca and MSD’s treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

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FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19

MedCity News

The FDA has issued a warning letter to a website that has been selling the antiparasitic drug ivermectin as a treatment for Covid-19. The correspondence directs the company to stop selling its products and correct any misleading language in its marketing material.

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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.

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Making the leap from the lab to the boardroom

PharmaVoice

Four academics-turned-executives share what they’ve learned about the pivot point between life sciences academia and entrepreneurship.

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CCC to Host Virtual Town Hall on ChatGPT and Information Integrity

Copyright Clearance Center

March 21, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will present a Town Hall discussion via LinkedIn live on 30 March at 11:00 a.m. EDT/16:00 BST/17:00 CEST that will address the questions, “What is the evolving nature of originality and authenticity?” And “What place do human expertise and empathy have when machines provide information?

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Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission

MedCity News

Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.

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8 Vital Skills to be Successful in Medical Sales

MedReps

Obtaining a medical sales job requires more than just the medical skills and knowledge needed to successfully sell the products. You need to demonstrate that you have a number of other vital skills as well. 8 Vital Skills to be Successful in Medical Sales Many of these skills are enhanced or obtained while attending college, as the process of getting a degree teaches you soft skills like communication and time management, but they can be obtained in other ways as well.

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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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Astellas and Pfizer reveal positive results for Xtandi

PharmaTimes

Research data follows phase 3 EMBARK trial and involves men with non-metastatic prostate cancer

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Large medical center uses on-demand patient journey insights to identify $50M opportunity to grow their oncology service line

Clarify Health

A strategy team at a large urban medical center wanted to increase its hospital outpatient department (HOPD) and ambulatory surgery center (ASC) market share for oncology in their service area, but they had limited insight into their outpatient market. They needed to understand the best regions to increase the footprint of their oncology service line, which required assessing physician referral patterns for outpatient facilities.

Medical 52
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Vitestro raises vital funding for autonomous blood drawing device

PharmaTimes

Company raises €12m in financing with a view to entering to the European market

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The Benefits of Buying a Calgary Directory of Doctors

Scott’s Directories

If you’re looking to break into the medical industry and start selling to doctors in Calgary, then you need the right resources and information. That’s why buying a Calgary doctors directory is a great way to get your business off the ground. Here, we’ll discuss why a directory can be so beneficial, as well as other tips on how to successfully market your products and services to doctors in the area.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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FDA Considers Biomarker Data Supportive of Tofersen Approval

Pharma Leaders

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

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Sanofi’s Dupixent receives EC approval for atopic dermatitis

Pharmaceutical Technology

Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) for the treatment of severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU). This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of these young children.

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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Legacy MEDSearch

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). LUMISIGHT is intended for use with the Lumicell Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of

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Gilead Sciences to exclusively license Nurix Therapeutics’ protein degrader

Pharmaceutical Technology

Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. The potent, selective, oral IRAK4 degrader named GS-6791 targets the scaffold and kinase functions of the IRAK4 protein kinase for blocking the pro-inflammatory IL1 cytokine family of receptors (IL1Rs) and inflammatory responses downstream of toll-like receptors (TLR).

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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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Sanofi Drops Lantus US List Price by 78%, Capping Out-of-Pocket Costs at $35

PharmaTech

Sanofi intends to cut its US list price for Lantus (insulin glargine injection) by 78% and cap out-of-pocket costs at $35 for all patients with commercial insurance.

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SVB’s collapse had limited impact on biopharmas — but a broader financial crisis could change the landscape

PharmaVoice

Although many pharma and biotech companies had deposits at the failed bank, most have reported little to no exposure.

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BioNTech and OncoC4 to Co-Develop mAb for Solid Tumor Indications

PharmaTech

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

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Jessica Longo Discusses Support for Cardiometabolic Patients

Pharmaceutical Commerce

Novo Nordisk executive dives into supporting cardiometabolic patients within her current role.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.