Mon.May 20, 2024

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Pfizer unit wins $107.5M verdict in cancer-drug patent case against AstraZeneca

Fierce Pharma

A Delaware federal jury has ordered AstraZeneca to fork over $107.5 million to Pfizer for infringing two of the latter company's patents with its marketing of blockbuster oncology med Tagrisso. | Pfizer's Wyeth subsidiary and licensee Puma Biotechnology sued AstraZeneca in 2021 for alleged patent infringement related to AZ's marketing of cancer blockbuster Tagrisso.

Marketing 307
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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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As Stelara nears patent cliff, J&J fortifies Tremfya for upcoming ulcerative colitis showdown

Fierce Pharma

The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. | The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space.

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Tax Challenges for Healthcare Accounting Teams Bring Opportunity for Innovation

MedCity News

A good outsourced partner can work alongside in-house accountants and stay on top of the moving target of healthcare accounting regulations, addressing tax risks and identifying cost-saving opportunities. The post Tax Challenges for Healthcare Accounting Teams Bring Opportunity for Innovation appeared first on MedCity News.

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

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Lab at center of Zantac saga claims GSK hid drug’s risks for decades

Fierce Pharma

Even as GSK defends itself against thousands of personal injury lawsuits relating to its sale of heartburn pill Zantac, a whistleblower lawsuit from the laboratory that first raised alarm bell | A newly unsealed complaint from the laboratory that first revealed Zantac's links to a carcinogenic impurity lays out a web of allegations about GSK's efforts to bring the drug to market in the 1980s and its attempts to hide the risks since then.

Sales 295
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Why AlphaFold 3 is stirring up so much buzz in pharma

PharmaVoice

The “Nobel Prize-worthy invention” could be worth hundreds of billions commercially — and have a deep impact on drug R&D.

Pharma 122

More Trending

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Nutrition Counseling Startup Emerges from Stealth with $25M

MedCity News

Fay emerged from stealth with $25 million in funding. The company connects patients to a network of registered dietitians. The post Nutrition Counseling Startup Emerges from Stealth with $25M appeared first on MedCity News.

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Serum Institute deploys first doses of Oxford, Novavax-partnered malaria shot to Africa

Fierce Pharma

As some industry efforts to deliver vaccines to Africa have fallen by the wayside, Serum Institute of India (SII), together with the U.K.’s University of Oxford and U.S.-based Novavax, are making g | Serum Institute of India—the world’s biggest vaccine producer by number of doses—said it shipped the first tranche of R21/Matrix-M malaria vaccines to Africa.

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Novavax investor withdraws proxy fight after Sanofi deal

pharmaphorum

Shah Capital Management has withdrawn a proxy campaign against the re-election of director at vaccines firm Novavax in the wake of its $1.2 billion alliance with Sanofi. The top-three investor in Novavax – which has been steadily raising its stake in the company in recent weeks and now holds around 7.9% – said it welcomed the Sanofi deal but warned that “does not mean our engagement is at an end” and it still believes Novavax would benefit from a stockholder on its board of directors.

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3rd time's the charm? PTC will get another chance to keep Translarna's European marketing authorization

Fierce Pharma

Four months after Europe's drug reviewers doubled down and recommended the withdrawal of PTC Therapeutics' Translarna for lack of efficacy, the drug's regulatory odyssey is taking yet another | Two negative recommendations from the Committee for Medicinal Products for Human Use were not enough to convince the European Commission that Translarna should be removed from the market.

Marketing 249
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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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AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs

MedCity News

The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. AstraZeneca aims to open the facility in 2029. The post AstraZeneca Plans $1.5B Manufacturing Site for Global Production of ADC Cancer Drugs appeared first on MedCity News.

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AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore

Fierce Pharma

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a b | Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a big bet on the cancer-fighting technology as it blueprints a massive manufacturing investment in Asia.

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ATS: Amgen, AZ say data backs Tezspire’s role in COPD

pharmaphorum

Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication for the drug – despite missing its primary objective in a clinical trial.

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Despite midstage trial miss, Amgen and AstraZeneca see promise for Tezspire in COPD

Fierce Pharma

Sanofi and Regeneron’s Dupixent appears set up for a key FDA approval this summer for chronic obstructive pulmonary disorder (COPD). | Sanofi and Regeneron’s Dupixent appears set up for a key FDA approval this summer for chronic obstructive pulmonary disorder (COPD). But a second biologic treatment could be on its heels in the indication. Amgen and AstraZeneca have reported data that did not meet the primary endpoint of a phase 2a trial but did show the effectiveness of their asthma drug Tezspir

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug

MedCity News

The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented. The post European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug appeared first on MedCity News.

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ATS: Vicore, Endeavor therapies show promise in IPF

pharmaphorum

Phase 2a data with drugs for idiopathic pulmonary fibrosis from Vicore and Endeavor raise hopes of disease-modifying therapy for the disease

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Centivo Acquires a Primary Care Startup, Despite Others Fleeing the Space

MedCity News

Centivo, a health plan that sells to self-funded employers, acquired virtual-first primary care startup Eden Health. With this acquisition, Centivo now serves more than 160 employers in all 50 states. The post Centivo Acquires a Primary Care Startup, Despite Others Fleeing the Space appeared first on MedCity News.

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AstraZeneca announces $1.5b ADC manufacturing facility

European Pharmaceutical Review

A new $1.5 billion antibody drug conjugate (ADC) manufacturing facility in Singapore is set to increase global supply of AstraZeneca’s ADC portfolio. More about the ADC facility The planned greenfield facility will be the company’s first end-to-end ADC production site” The planned greenfield facility will be the company’s first end-to-end antibody drug conjugate production site.

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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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Cervical cancer elimination in the UK is within sight with HPV vaccine

Pharmaceutical Technology

A recent study in England has shown that the HPV vaccine in teenagers reduced the rate of cervical cancer by up to 85%.

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AstraZeneca Plans $1.5 Billion ADCs Facility in Singapore

PharmaTech

The new facility will be the company’s first to offer full manufacturing processing for antibody drug conjugates.

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AstraZeneca to Build $1.5 Billion Antibody Drug Conjugates Manufacturing Plant in Singapore

Pharmaceutical Commerce

The facility, company says, will be its first that covers end-to-end ADC production.

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Vicore and Endeavor’s therapies show promise in treating IPF

PharmaTimes

Both drugs have the potential to offer a disease-modifying approach to the lung disease

Pharma 101
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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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Unlocking Transparency in PBM Pricing

MedCity News

Dan Reedy, senior director of pricing and underwriting for Abarca, spoke recently with MedCity News about what payers should consider as they explore new models and press for greater transparency. The post Unlocking Transparency in PBM Pricing appeared first on MedCity News.

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KCL researchers identify key features of autoimmune diseases present in the gut

PharmaTimes

Globally affecting 4% of the population, autoimmune diseases mistakenly attack healthy cells, tissues and organs in the body

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AstraZeneca unveils plan for $1.5bn ADC plant in Singapore

pharmaphorum

AstraZeneca is backing up its big investments in antibody-drug conjugates (ADCs) with the construction of a $1.5bn new facility in Singapore.

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Pharma Pulse 5/20/24: Getting Pharma Ready for Generation Alpha, Teens Ask Schools to Provide Mental Health Information & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 105
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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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EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

PharmaTech

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

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Biotechs Rapport and Telix throw their hats into IPO ring

pharmaphorum

Biotechs Rapport and Telix throw their hats into IPO ring Phil.

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Why Salesforce Managed Services Is More Than Just Administration

Penrod

5 Reasons Salesforce Managed Services Need to be More Than Admins Since 1999 , Salesforce has grown from a simple CRM platform into a sophisticated ecosystem that is managed by data managers, business analysts, security managers, and integration specialists – cross-functional teams bring a range of capabilities essential for optimizing Salesforce performance.

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US Pharma and Biotech Summit 2024: The 2024 Presidential Election and the Pharma Industry

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry.

Pharma 52
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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.