Sat.Jan 21, 2023 - Fri.Jan 27, 2023

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Five Actionable Steps To Elevate Your Sales Skills For The New Year

Integrity Solutions

The past several years have certainly tested the mettle of even the most experienced salespeople and sales managers. With a new year already upon us, questions still remain about the economy and other external factors, but regardless of those outside variables, there are a number of steps sales teams can take to build up sales skills that will lead to a strong foundation for success in the months ahead.

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BMS settles lawsuit with two fired employees who refused COVID vaccines

Fierce Pharma

BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30

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Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies

MedCity News

A collaboration between Nvidia and startup Evozyne was able to produce novel versions of a human protein never before seen in nature but with enhanced function and the same safety as native protein. The research lays the groundwork for potential new therapies for a rare inherited disorder.

Safety 143
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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

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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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Personalised cancer immunotherapy granted fast track designation

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine,” stated Per Norlén, CEO at Denmark-based Evaxion.

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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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A new dawn of the genomic age: five areas set to be transformed in 2023

pharmaphorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

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First CAR T-cell therapy recommended on NHS

European Pharmaceutical Review

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

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With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug

Fierce Pharma

With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug aliu Fri, 01/27/2023 - 15:29

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Pearl Health Rakes In $75M to Enable More Physician Participation in VBC

MedCity News

Pearl Health — a technology company that helps independent physician practices participate in value-based care models — just raised $75 million in Series B financing. Pearl’s platform leverages data science to help primary care providers focus on patients who are driving expenses and need care the most.

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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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Current and future players in the lupus market

Pharmaceutical Technology

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).

Marketing 111
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Limiting microbial hazards in inhaled cannabis products

European Pharmaceutical Review

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Multiple cases have been reported of infections associated with cannabis use caused by fungi and bacteria in immunocompromised individuals using inhaled cannabis material. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

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After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE

Fierce Pharma

After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE fkansteiner Wed, 01/25/2023 - 18:51

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Leapfrog: Employers Give Health Plans a ‘C’ Letter Grade

MedCity News

A survey from The Leapfrog Group asked employers to give their health plans an “A” through “F” letter grade. From those letter grades, Leapfrog calculated the health plans’ average Grade Point Average (GPA) on a 4.0 scale. Health plans received a 2.29 GPA in 2022, a slight decrease from Leapfrog’s prior survey in 2020, which had a 2.57 GPA.

Insurance 134
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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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Why Are Patients So Angry? Plus, Frontliner Tips for Health Leaders

Healthcare Success

It’s not your imagination. People really are ruder to each other these days. The pandemic, economy, political unrest, war, and continued uncertainty have taken—and continue to take—a toll on people’s mental health. These all contribute to stress, anxiety, frustration, and anger. And according to Harvard Business Review , frontline workers are taking the brunt of this unrest and aggression.

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FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

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Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira

Fierce Pharma

Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira zbecker Fri, 01/27/2023 - 11:50

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Digital Health Insurance Provider Angle Health Pulls in $58M

MedCity News

The $58 million funding round was led by Portage and included participation from PruVen Capital, Wing Venture Capital and others. With the funding, Angle Health plans to expand into additional markets and grow its membership.

Insurance 122
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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J&J copay lawsuit against drug benefit firm gets green light

pharmaphorum

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug

Insurance 104
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Health Canada accepts Veru’s Covid-19 therapy NDS-CV for review

Pharmaceutical Technology

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.

Pharma 98
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J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma

Fierce Pharma

J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma aliu Fri, 01/27/2023 - 11:02

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Top 5 Compliance Issues for Medtech Firms Transitioning To Data-enabled Solutions

MedCity News

Medtech companies should be particularly mindful of the following legal and regulatory compliance issues. This is especially true for companies transitioning to data-based services.

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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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Tackling ongoing staffing burnout rates through AI-enabled precision oncology

pharmaphorum

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.

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Virtual Patient Engagement Program: A Customer Story

Impetus Digital

O ur client wanted to better understand the needs, preferences, and treatment gaps among adult patients with a rare genetic disease in the USA. They had first conducted a virtual advisory board with physicians treating this condition but wanted to supplement that initiative by gathering patient insights to get a more comprehensive and accurate picture.

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Bristol Myers doubles down in immuno-oncology patent fight with AZ, this time targeting Imjudo

Fierce Pharma

Bristol Myers doubles down in immuno-oncology patent fight with AZ, this time targeting Imjudo fkansteiner Tue, 01/24/2023 - 16:13

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How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

MedCity News

The agency’s goal is to spur a macro shift in clinical trials. The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.

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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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ABPI code updated with first social media guidance

pharmaphorum

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical In

Media 104
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4 Reasons Pharma’s Organizational Structures Are Not Built for Digital Transformation

PM360

Spurred into action by the pandemic, many pharma brands are undertaking or accelerating their digital transformations. While many have already moved to agile, technology-based approaches for HCP and DTC outreach, it’s time for us to assess our progress and consider a few tweaks to improve our approach. Five key areas impact digital adoption and effectiveness: Organizational Structures Diversity, Equity, and Inclusion Omnichannel Marketing Strategy Creative Development and Deployment Medicare Cha

Media 96
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As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO

Fierce Pharma

As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO fkansteiner Wed, 01/25/2023 - 11:09

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Marriage of Artificial Intelligence & Biology Spawns RNA-Targeting Startup Atomic AI

MedCity News

Atomic AI combines artificial intelligence analysis with wet lab experiments to discover small molecules capable of drugging RNA. The startup, based on technology initially developed at Stanford, is backed by a $35 million Series A round of financing.

Biopharma 117
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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.