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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Major study on DMT shows promise for depression

European Pharmaceutical Review

The first major study on the efficacy of DMT in treating any mental health condition showed a remission rate of 57 percent following a single dose, in a Phase IIa trial for major depressive disorder (MDD). “SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57 percent at three months following a single dose of SPL026,” stated Dr Carol Routledge, Chief Medical and Scientific Officer at Small P

Safety 133
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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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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

FDA 132
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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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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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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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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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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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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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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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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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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 121
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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.

Patients 109
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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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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 116
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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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EMA validates first regulatory submission for CRISPR-based medicine

European Pharmaceutical Review

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. Through the validation, exa-cel is indicated for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The MAA from Vertex Pharmaceuticals and CRISPR Therapeutics is supported by two global Phase III studies.

Medicine 111
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Call to arms as UK falls back in medicines manufacturing

pharmaphorum

Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. A just-published report from the Medicines Manufacturing Industry Partnership (MMIP) – set up by the UK government and biopharma industry in 2014 to drive growth in the category – says the sector has the potential to be a driver for the UK economy in the next decade.

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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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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 127
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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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ebook: Extractables and leachables: a guide to analytical methods

European Pharmaceutical Review

Typical extractables and leachables (E/L) studies aim to identify, quantify and ultimately minimise any impurities that can migrate from packaging into a final product or drug. Gas or liquid chromatography-mass spectrometry (LC/MS) or (GC/MS) have been widely used in extractables studies however, there are several challenges associated with E&L analyses including: Detection and quantification of unknowns Sensitivity and detection at trace levels Reducing uncertainty factors Increasing s

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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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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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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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New UK point of care manufacturing regulatory framework

European Pharmaceutical Review

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Once implemented the manufacturing regulatory framework will apply to all point of care (POC) products manufactured in the UK, such as: Advanced therapy medicinal products (ATMPs), such as cell therapy , gene therapy and tissue engineered products 3D prin

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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 105
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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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Healthcare Travel Cost Coverage Benefits Employees and Employers

MedCity News

Covering travel expenses is not an act of altruism for employers. It’s in their financial interest to have their workforce access the specialized care they need to feel better rather than consigning them to an inadequate care treadmill at the local hospital.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time