Mon.Jul 01, 2024

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After Gilead and J&J lawsuits, distributor Safe Chain sees its owners charged with wire fraud, conspiracy

Fierce Pharma

In yet another legal development surrounding counterfeit HIV drugs, a Florida court has handed down an indictment for the owners of a wholesale distributor that allegedly bought and redistribu | The wholesaler Safe Chain allegedly purchased $90 million of misbranded, diverted and adulterated HIV meds, according to U.S. authorities. The indictment of the company's three owners follows separate lawsuits from Gilead and Johnson & Johnson.

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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

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GSK takes another Zantac personal injury case off its plate with settlement in Illinois

Fierce Pharma

GSK scratched another Zantac lawsuit off the list with a confidential settlement in Illinois as it continues to work through the mountain of personal injury litigation related to the heartburn pill | Following a win and a separate dismissal in Illinois, GSK agreed to a confidential settlement to resolve prostate cancer claims put forward by plaintiff Martin Gross.

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One Conversation Could Be All It Takes to Identify Chronic Kidney Disease

MedCity News

No one should ever learn about CKD after their kidneys have already failed. The post One Conversation Could Be All It Takes to Identify Chronic Kidney Disease appeared first on MedCity News.

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

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Talc claimants denied in effort to block Johnson & Johnson's latest Texas two-step bankruptcy

Fierce Pharma

Less than three weeks after a group of cancer victims filed a motion against Johnson & Johnson attempting to block the company’s latest bankruptcy plan—which comes with a $6.5 billion class-act | Less than three weeks after a group of cancer victims filed a motion attempting to block Johnson & Johnson's latest talc litigation bankruptcy plan—which comes with a $6.5 billion class-action settlement offer—a New Jersey federal court has quashed the effort.

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The Role of AI in Empowering Early Lung Cancer Detection & Transforming Patient Outcomes

MedCity News

AI-powered solutions for opportunistic lung cancer detection using routine chest X-rays offer hope for improved early diagnosis and survival rates. The post The Role of AI in Empowering Early Lung Cancer Detection & Transforming Patient Outcomes appeared first on MedCity News.

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K Health’s Latest Funding Round Brings the Primary Care AI Startup to $380M Raised

MedCity News

K Health closed a $50 million equity funding round, which brought its total fundraising amount to $380 million and propelled the startup to a $900 million valuation. The company, which was founded in 2016, uses AI to educate patients about their symptoms and connect them to primary care. The post K Health’s Latest Funding Round Brings the Primary Care AI Startup to $380M Raised appeared first on MedCity News.

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As former BMS CEO Giovanni Caforio plots move to Novartis, will noncompete issues come into play?

Fierce Pharma

Fierce Pharma explored the status of the industry's noncompete clauses with experts to learn whether an intercompany transition at the highest levels can proceed without a hitch.

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Lilly builds in radiopharma with $140m Radionetics deal

pharmaphorum

Eli Lilly has lined up another deal in the radiopharmaceutical sector, paying $140 million to partner drugs developed by Radionetics Oncology and taking an option on buying the company outright for $1 billion.Radionetics is working on small-molecule drugs that target G protein-coupled receptors (GPCRs), a fertile source of drug targets for the pharma industry and the target of around a third of all marketed drugs but according to the company is a “largely unexplored” class for radiopharma.

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.

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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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France agrees to fund experimental glioblastoma therapy

pharmaphorum

France's HAS agrees to fund treatment with Carthera's ultrasound device for French subjects enrolled in a glioblastoma trial.

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Eli Lilly Puts $1B on the Line to Expand its Cancer Radiopharmaceuticals Prospects

MedCity News

Eli Lilly is paying $140 million for the exclusive right to buy Radionetics Oncology for the price of $1 billion. The clinical-stage startup, a Crinetics Pharmaceuticals spinout, develops radiopharmaceuticals that target GPCRs overexpressed by solid tumors. The post Eli Lilly Puts $1B on the Line to Expand its Cancer Radiopharmaceuticals Prospects appeared first on MedCity News.

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NeuroSense says ALS drug extends survival

pharmaphorum

NeuroSense Tx reports 12-month data with its amyotrophic lateral sclerosis therapy PrimeC, including a 43% improvement in survival

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5 Funding Announcements from Payer/Employer Companies In June

MedCity News

Here is a list of some of the biggest funding rounds in the payer/employer space that were announced in June. The post 5 Funding Announcements from Payer/Employer Companies In June appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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How to Market Sensitive Healthcare Topics: A Guide

Healthcare Success

When my wife Clara met her new workout trainer, he asked, “What can I help you with?” She replied with a smile, “menopause.” She elaborated, “My doctor helps me with hormone therapy, and I work out five days a week at a boot camp. But I feel stuck with the way I look and feel. I want to lose fat, build muscle, and feel healthier.” When she shared this story with me, we laughed and remarked on how far things have come in recent years.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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University of Liverpool launches new biotech spin-out company Galytx

PharmaTimes

The biotech company will develop novel therapeutic drugs for the treatment of fatal diseases

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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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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

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First Nasal Adrenaline Spray Among EMA Approvals in June

PharmaTech

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

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Maximizing Your Content Investment

Eversana Intouch

Repurposing content is a smart strategy that can enhance your content marketing efforts without breaking the bank. Specifically in pharmaceutical marketing, effective content repurposing can streamline efforts, maintain compliance and enhance brand engagement. In this POV, EVERSANA INTOUCH’s content strategy experts, Carrie Bolin and Jesse Brown, dive into the benefits and practical steps for effective content repurposing for your brand.

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Risk adjusted net present value: What is the current valuation of AstraZeneca’s Rilvegostomig?

Pharmaceutical Technology

Rilvegostomig is a monoclonal antibody commercialized by AstraZeneca, with a leading Phase III program in Non-Small Cell Lung Cancer.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Leveraging data and AI for clinical trial success

pharmaphorum

Over 90% of experimental therapies that reach human trials fail to make it to market. In today’s pharmaphorum podcast, Orr Inbar, co-founder and CEO of QuantHealth, a Tel Aviv-based AI-powered clinical trial design company, discusses how advances in data and AI can help. This includes cost-effectiveness. Ever a ‘game’ of risk-and-reward, leveraging data and technology can increase clinical trial success rates, bringing down the failure rate some 20%, potentially.

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Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Suzetrigine?

Pharmaceutical Technology

Suzetrigine is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Post-Operative Pain.

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ICL granted £150,000 to explore link between breast cancer and breastfeeding

PharmaTimes

Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers

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Risk adjusted net present value: What is the current valuation of Atai Life Sciences’s RL-007?

Pharmaceutical Technology

RL-007 is a small molecule commercialized by Atai Life Sciences, with a leading Phase II program in Diabetic Neuropathic Pain.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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J&J adds another string to nipocalimab bow with gMG data

pharmaphorum

Johnson & Johnson has reported new phase 3 data with its FcRn blocker nipocalimab in generalised myasthenia gravis (gMG), pointing to data that it says differentiates it from other drugs in the class.The results from the Vivacity-MG3 study, presented at the European Academy of Neurology (EAN), show an improvement with nipocalimab compared to placebo on activities of daily living scores that have not been seen with other FcRn inhibitors, according to J&J.

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Risk adjusted net present value: What is the current valuation of Atai Life Sciences’s RL-007?

Pharmaceutical Technology

RL-007 is a small molecule commercialized by Atai Life Sciences, with a leading Phase II program in Diabetic Neuropathic Pain.

Leads 75
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AI’s Promise in Delivering on Patient-Centricity

PharmExec

How pharmaceutical companies can utilize AI at key stages of the treatment journey to enhance patient-centric engagement by increasing empathy and humanity in patient interactions.

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Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Suzetrigine?

Pharmaceutical Technology

Suzetrigine is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Post-Operative Pain.

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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.