Sat.Aug 26, 2023 - Fri.Sep 01, 2023

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‘We need to do better:’ A biotech CEO on standing apart from the crowd

PharmaVoice

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse

Fierce Pharma

After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.

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Bon Secours Mercy Health Sues Anthem Health Plans of Virginia for Unpaid Claims

MedCity News

In a new lawsuit, Bon Secours Mercy Health Virginia alleges that Anthem Health Plans of Virginia owes the health system more than $93 million in outstanding unpaid and underpaid claims. The post Bon Secours Mercy Health Sues Anthem Health Plans of Virginia for Unpaid Claims appeared first on Above the Law.

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Intelligent OMICS partners with Janssen on AI-driven research

PharmaTimes

The AI platform and expertise will be combined to discover novel targets for haematological cancers - News - PharmaTimes

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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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Stem cell therapy delivers potential for sickle cell disease

European Pharmaceutical Review

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Based on new data from the Novartis Phase I/II clinical trial , which used the first therapy to target a new genetic area and use cryopreserved stem cells, trial participants reported a decrease in vaso-occlusive events.

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Johnson & Johnson's spinoff of Kenvue provides $13.2B in potential M&A firepower

Fierce Pharma

Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.

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More Trending

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Twist Bioscience and Ono Pharmaceutical collaborate

PharmaTimes

Partnership will discover and develop novel antibodies for a range of autoimmune diseases - News - PharmaTimes

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$2 billion mRNA-based oncology therapy market anticipated by 2029

European Pharmaceutical Review

The global mRNA-based oncology therapy market is expected to reach $2 billion by 2029, according to GlobalData. BioNTech is anticipated to lead the market with a predicted $885 million in sales, and a 44.6 percent share by 2029, the research has shown. Global mRNA-based oncology therapy market At present, the pharmaceutical industry is still awaiting the first regulatory approval of an mRNA-based oncology therapy. mRNA stability and delivery specificity are two of the main obstacles hindering pr

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Amgen's $28B Horizon buyout cleared for takeoff after FTC, states settle

Fierce Pharma

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. | Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address “the potential competitive harm” that could result from the merger deal. Now, Amgen is free to go forward with its $28 billion buyout.

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Debunking Healthcare’s Recession-Proof Reputation

MedCity News

During past recessions, the healthcare sector remained relatively immune to economic downswings — but things are different now that a sweeping labor shortage and lower patient volumes have been added to the mix.

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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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UCB announces approval of Bimzelx

PharmaTimes

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes

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Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Pharmaceutical Technology

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

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FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls

Fierce Pharma

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.

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Still Hungry for New Obesity Meds, Novo Nordisk Makes Another M&A Deal

MedCity News

Novo Nordisk is expanding its cardiometabolic drug pipeline with the acquisition of Embark Biotech, a startup developing drugs for a novel target that can suppress appetite and boost calorie burning in cells. Embark’s science comes University of Copenhagen research on a novel fat cell target.

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

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BenevolentAI doses participants in BEN-8744 study

PharmaTimes

The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes

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A startup’s psychedelic delivery tech is grabbing attention. Will pharma listen?

PharmaVoice

Psycheceutical is developing a back-of-the-neck topical treatment for ketamine but believes the delivery route holds promise for far more drugs.

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Bayer bets big on Kerendia's potential to treat heart failure

Fierce Pharma

Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. | Bayer plans three new trials to assess its potential blockbuster medicine Kerendia in heart failure. The drug was first approved 2 years ago in CKD associated with diabetes.

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Study On Teen Mental Health App Shows High Engagement, Positive Impact

MedCity News

A study on BeMe Health, a behavioral health platform for teens, found that users engaged with the platform eight times on average over a month. The study was done in collaboration with Stanford University.

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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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Guidance for medicine packaging under Windsor Framework

European Pharmaceutical Review

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. In preparation for the implementation of these requirements under the Windsor Framework, new guidance for the industry was published by the MHRA on 28 July 2023.

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HDA 2023 Traceability Seminar: An FDA DSCSA Overview

Pharmaceutical Commerce

Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.

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Following in Tecentriq's footsteps, Alecensa gives Roche another win in early-stage lung cancer

Fierce Pharma

After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. | After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa.

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Developing Nursing Clinical Judgment Competency Through Virtual Reality

MedCity News

When real-life failure is not an option, practicing curated, trial-and-error simulations in VR can reduce patient risk in high-acuity scenarios. With nursing faculty also in short supply and a wave rapidly approaching retirement age, virtual reality simulations can help bridge the gap between learners needing supervised clinical experiences, and time-pressed preceptors, who have their own patients to care for in addition to guiding novices in clinical settings.

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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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Novo Nordisk acquires Embark and lead asset metabolic programme

Pharmaceutical Technology

Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.

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Peptoid Oligomers Target Viral Membranes

Medgadget

Researchers at New York University have developed a new method to target many viruses that cause disease. For viruses with a lipid membrane, which includes many that commonly cause disease, this new technique could prove to be fatal. By targeting the lipid membrane, the approach may circumvent the treatment resistance that arises when viruses mutate to alter their surface proteins, which are the most common targets for conventional anti-viral drugs.

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Johnson & Johnson slashes price of tuberculosis drug Sirturo after relinquishing patent protections

Fierce Pharma

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson h | Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price by 55% to $130 for a six-month course.

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Strive Health, Oak Street Health Strike Kidney Care Partnership

MedCity News

Kidney care company Strive Health announced last week that it is collaborating with primary care company Oak Street Health to serve Medicare members with stage 4 chronic kidney disease and end-stage kidney disease.

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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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Otsuka Pharmaceutical agrees to buy Mindset Pharma

Pharmaceutical Technology

Otsuka Pharmaceutical has signed a definitive arrangement agreement to acquire Mindset Pharma, in an all-cash deal worth C$80m ($59.1m).

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IMA: the all-in-one solutions provider for complete vaccines lines

European Pharmaceutical Review

In the wake of the COVID-19 pandemic, we have now acquired a much clearer understanding of how fast a virus spreads. Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. This has led pharmaceutical equipment manufacturers to react quickly, while maintaining due levels of diligence and social responsibility.

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Catalent passes baton to activist investor Elliott after 2023 earnings disappoint

Fierce Pharma

After a tumultuous year of manufacturing hiccups, executive turnover and dwindling revenues, Catalent is handing the reins to activist investor Elliott Management. | After a tumultuous year of manufacturing hiccups, executive turnover and dwindling revenues, Catalent is linking up with Elliott Management. The CDMO giant struck a cooperation agreement with the activist investor group as it announced fourth-quarter revenues and unveiled a sweeping governance shakeup.

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What Do Value-Based Care Startups Need to Do to Attract Investors?

MedCity News

As the value-based care market gets more crowded, startups in this space will have to nail down the fundamentals in order to attract capital from investors, healthcare business expert Paul Campbell said during a virtual conference. He encouraged startups to be crystal clear about what their value proposition is for three main stakeholders — patients, providers and payers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time