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

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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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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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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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Tracey Armstrong Named to Forbes 2023 “50 Over 50” List

Copyright Clearance Center

August 29, 20 23 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces that its President and CEO, Tracey Armstrong, was named to the Forbes 2023 “ 50 Over 50 ” list. The third annual Forbes “50 Over 50” list features a collection of powerful founders, innovators, and creators that have a deep sphere of influence and are changing the world.

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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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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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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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siRNA therapy shows long-term potential in lowering LDL-C

European Pharmaceutical Review

Novartis has announced that Leqvio ® (inclisiran) , the first and only small interfering RNA (siRNA) therapy indicated to reduce low-density lipoprotein cholesterol (LDL-C), has demonstrated promising long-term results. This is based on three-year follow up data from a Phase III trial, presented at the European Society of Cardiology (ESC) Congress 2023.

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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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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 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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$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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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.

Pharma 105
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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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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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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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CGT manufacturing QC market to value $2.8b by 2031

European Pharmaceutical Review

According to a report by Transparency Market Research Inc, the global cell and gene therapy (CGT) manufacturing quality control (QC) market is anticipated to value $2.8 billion in 2031. It is projected to expand at a CAGR of 24.6 percent from 2023 to 2031. Comparatively, the market is expected to value $463.1 million by the end of 2023. With increasing research and development in the cell and gene therapy field, the demand for optimal quality control is needed to ensure the safe and efficient ma

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Finding the right flu vaccine is hard. Getting people to take it is harder.

PharmaVoice

Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

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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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Team-Based Primary Care Offers a Solution for an Underachieving Healthcare System

MedCity News

Team-based primary care is needed now more than ever as our “on-demand” and mobile lives, complicated by a primary care shortage crisis, have led to a more transactional and fragmented healthcare experience.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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European regulatory perspective on nitrosamine mitigation strategies

European Pharmaceutical Review

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated.

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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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Data Access and Equity: How Secure Engagement Data Sharing Makes for Healthier Patients

MedCity News

The fusion of clinical and engagement data can revolutionize the way we understand and treat patients. By optimizing data collection and synthesis, securely sharing data, and ensuring equitable access, we can make significant strides towards delivering more personalized, effective, and patient-centered care.

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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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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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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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Sanofi shakes up leadership as specialty care head Sibold departs to pursue outside opportunity

Fierce Pharma

For six years, Sanofi's specialty care chief Bill Sibold has helped the company make the most of its Regeneron-partnered immunology superstar Dupixent. | Bill Sibold, who took over the company's specialty care unit in 2017 just after Dupixent's first approval, is leaving Sanofi effective immediately. The company further shook up its leadership by appointing a new R&D head, a chief digital officer and adding an entirely new position.

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Streamlining Healthcare Insurers’ Processes: Unlocking Efficiency and Collaboration for Enhanced Outcomes

MedCity News

While the recent rollbacks of authorization requirements by insurers are a positive step forward, there is still work to be done in streamlining processes and reducing administrative burdens in the healthcare industry.

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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.