Mon.May 20, 2024

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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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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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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.

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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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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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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.

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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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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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Why patient-centricity is essential to accelerate rare disease clinical research

European Pharmaceutical Review

Rare diseases affect up to 36 million people in the EU, and as many as 400 million people globally. 1,2 they are often progressive, life-limiting and incurable. Half of people diagnosed with a rare disease are children, 30 percent of whom die before they reach the age of five. 3 Significant unmet needs The path to diagnosis of a rare disease is complex, taking on average five to eight years from the onset of symptoms before a patient receives an accurate diagnosis. 4 In some countries, limited a

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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.

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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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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.

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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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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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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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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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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: 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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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

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

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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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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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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.

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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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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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UK clinical trial regulation may support haemophilia treatment access

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) new Notification Scheme for lower-risk clinical trials has enabled an application for a Phase IV haemophilia A clinical trial to be accepted by day 14. approximately 20 percent of UK initial clinical trial applications are anticipated to be eligible [for the MHRA’s new Notification Scheme]” The treatment, Nuwiq, is a fourth-generation recombinant FVIII is indicated for severe haemophilia A in patients undergoing major sur

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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 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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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FDA Approves Belimumab for Patients Aged 5 With Systemic Lupus Erythematosus

Pharmacy Times

Belimumab (Benlysta; GSK) is a B-lymphocyte stimulator-specific inhibiting monoclonal antibody.

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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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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