Tue.Nov 28, 2023

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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 Pharma customer experience trends and CX measurement best practice

Dominic Tyer

Alongside my DT Consulting colleague Eleni Lee I'll be appearing at the BHBIA's 2023 Winter Seminar to present some of our customer experience data and discuss CX measurement best practices

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Trending Sources

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Pfizer takes Poland to court over alleged missed COVID-19 vaccine payments

Fierce Pharma

As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union. | As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union.

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FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

MedCity News

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

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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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Gilead cuts 7% of staff at Kite Pharma unit as 'refreshed business strategy' introduced

Fierce Pharma

Gilead Sciences' Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. | Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the un

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Philips Launches New Cloud-Based PACS & Unveils Mobile MRI System

MedCity News

Two of Philips’ most notable RSNA announcements were that its new cloud-based PACS is available and that its helium-free mobile MRI system will soon be deployed. More than 80 sites across the U.S. and Latin America have already migrated to Philips’ new PACS, and its mobile MRI system will be traveling to various cities next year.

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A New Deal for Hospitals

MedCity News

Hospitals that are able to transform what they are and how they operate can survive and serve the public well. They will still require investments from society in the interim, but that investment will be justified by the public good and eventually represent a windfall to taxpayers.

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Novartis dials up midterm sales projection, fleshes out Kisqali's $7B-plus goal

Fierce Pharma

Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs. | Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs, including Entresto and Kisqali.

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Integrated Technology Helps Nurses Make Time for the Moments That Matter

MedCity News

If we can simplify nurses’ work by embracing technology that streamlines, automates, and integrates processes like scheduling, credentialing, and compliance management to enhance quality outcomes, we can give nurses time back to spend on the moments that matter most.

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After Cyfendus' full approval, Emergent clinches $75M anthrax vaccine supply pact in US

Fierce Pharma

Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.

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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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First pill for desmoid tumours approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. SpringWorks Therapeutics’ Ogsiveo (nirogacestat) tablets are authorised for adults with progressing desmoid tumours who require systemic treatment. A new treatment for desmoid tumours As a subtype of soft tissue sarcomas: “Desmoid tumours are rare [non-cancerous] tumours that can lead to severe pain and disability… [Ogsiveo is] the first approved tr

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On blockbuster path, Argenx's red-hot Vyvgart comes up short in thrombocytopenia trial

Fierce Pharma

On a roll with Vyvgart—which is on its way to blockbuster sales in just its second year on the market for generalized myasthenia gravis (gMG)—argenx’s heat check in another indication has missed ba | On a roll with Vyvgart, argenx’s heat check in another indication has missed badly. On Tuesday, the Dutch company revealed that its subcutaneous formulation of the drug, Vyvgart Hytrulo, has flunked primary and secondary endpoints in a phase 3 study in a rare bleeding disorder, primary immune thromb

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FDA Approval of SpringWorks Drug Is the First for Rare Connective Tissue Tumor

MedCity News

SpringWorks Therapeutics drug Ogsiveo is now FDA-approved for treating desmoid tumors, a type of tumor affecting connective tissue. The regulatory decision makes the pill the first therapy approved specifically for treating this rare disorder.

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Biden looks to broaden HHS powers to bolster domestic drug manufacturing

Fierce Pharma

As drug shortages mount in the U.S. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains. | Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to bolster production networks across industries. Among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages.

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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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Why Consumers Should Care About Biomarkers — And How Technology Developers and Manufacturers Can Bridge the Gap

MedCity News

More precise and consumer-friendly biomarker detection technologies are coming to market at a pace that can help users gain rich insight into their health and well-being from anywhere and at any time. This is especially important when it comes to preventive healthcare.

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Teva drops patent case against Lilly after two Ajovy patents deemed invalid

Fierce Pharma

It’s the end of the road for one of Teva’s patent lawsuits against migraine competitor Eli Lilly. | The agreement comes after a patent board ruled that two Teva patents were invalid. Meanwhile, the companies continue to battle it out in a larger case relating to nine of Teva's Ajovy patents.

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Season Health Expands Provider Network Through Strategic Asset Acquisition from Wellory

MedCity News

By acquiring clinical assets from Wellory, Season Health will be able to greatly expand its provider network. The company will also gain national contracts with Aetna and Cigna.

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Cold storage market to value $383bn by 2032

European Pharmaceutical Review

Having been valued at $112 billion in 2022, the worldwide cold storage market is projected to witness a 12 percent compound annual growth rate (CAGR) between 2023 and 2032, according to a report by Towards Healthcare. Therefore, by the end of 2032, the market will value an estimated $383.05 billion, the research projected. Advancing cold storage for pharmaceuticals Temperature-sensitive pharmaceuticals requiring this type of storage include vaccines and biologics, the report explained.

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

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The United States Copyright Office Notice of Inquiring on AI: A Quick Take

Copyright Clearance Center

A selection of questions and answers from Copyright Clearance Center's response to the United States Copyright Office “Artificial Intelligence and Copyright" request for comment.

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Radiopharmaceuticals reach record high with $408m in venture financing for 2023

Pharmaceutical Technology

Venture financing for innovative radiopharmaceutical drugs witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US.

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Report: How Does Medicaid Perform Compared To Other Forms of Coverage?

MedCity News

A higher share of Medicaid beneficiaries rate their physical and mental health as fair or poor compared to adults with Medicare, employer-sponsored insurance or Marketplace coverage, according to a new KFF report. However, 83% of Medicaid enrollees gave their health insurance a positive rating.

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FDA accepts Orexo’s NDA for opioid overdose medication

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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How the IRA Has Created a New Environment for Biosimilars

MedCity News

As IRA provisions are activated, the law’s impact on biologics and biosimilars will become more apparent. By using both the carrot and the stick, the IRA may finally bolster the market, increasing uptake of biosimilars to benefit patients and help lower costs.

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Novovax’s Omicron-targeting Covid-19 vaccine obtains WHO emergency listing  

Pharmaceutical Technology

The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.

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Unmasking the Silent Epidemic: A Four-Point Plan to Tackle COPD

MedCity News

COPD is the sixth leading cause of death—but more than 50% of those impacted don’t even have a diagnosis. The so-called silent epidemic demands urgent action, as exorbitant costs and preventable deaths skyrocket. This four-point plan outlines a holistic strategy to address COPD.

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Acelyrin claims errors by CRO Fortrea led to late-stage trial downfall

Pharmaceutical Technology

A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Virtual Data Rooms are Securing the Next Wave of Medical Research Advancements

MedCity News

Developed as part of the due diligence process for the disclosure of confidential documents, VDRs provide a secure repository for all types of confidential materials including merger and acquisition (M&A) documents, financial statements, contracts, intellectual property details, and legal agreements.

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Clinical trial reveals positive results for treating children with rare gliomas

PharmaTimes

Tafinlar and Mekinist led to a 56% overall response rate in children with BM-HGG - News - PharmaTimes

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Boehringer puts IBM's genAI into its antibody discovery tank

pharmaphorum

Boehringer puts IBM's genAI into its antibody discovery tank Phil.

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AI-powered ‘MesoGraph’ tool could help clinicians diagnose cancer

PharmaTimes

Around 3,000 new cases of mesothelioma are diagnosed in the US every year - News - PharmaTimes

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A