Wed.Apr 24, 2024

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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Moderna turns to AI to change how its employees work

Bio Pharma Dive

An expanded partnership with OpenAI is helping Moderna embed custom-built AI chatbots in a wide range of research and business processes.

Research 280
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For The First Time, Scientists Showed Structural, Brain-Wide Changes During Menstruation

AuroBlog - Aurous Healthcare Clinical Trials blog

The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.

Scientist 187
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Biogen: Don’t expect any big acquisitions this year

Bio Pharma Dive

While the company is eager to diversify, CEO Chris Viehbacher said that in the near-term any dealmaking would likely focus on collaborations and early-stage assets.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Incyte signs deal to acquire Escient Pharmaceuticals

Pharmaceutical Technology

Incyte has agreed to acquire US-based Escient Pharmaceuticals and its assets including two first-in-class small molecule antagonists targeting Mas-related G protein-coupled receptor X2 (MRGPRX2) for the treatment of various mast cell-mediated disorders.

Protein 147
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CureVac to cut costs in restructuring

Bio Pharma Dive

The mRNA vaccine maker, which has lost most of its value since early 2021, is undergoing an “organizational redesign” that will involve the elimination of 150 positions.

More Trending

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Biogen sees ‘encouraging’ trends for postpartum depression drug

Bio Pharma Dive

First quarter sales of Zurzuvae doubled consensus estimates, though analysts are skeptical whether the better-than-expected launch will continue.

Sales 171
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Seres Therapeutics gets grant for composition of isolated bacteria in capsule for dysbiosis treatment

Pharmaceutical Technology

Discover the groundbreaking patent by Seres Therapeutics Inc for a unique composition targeting dysbiosis in mammals. Learn how specific bacterial species in a capsule can inhibit pathogenic bacteria growth.

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Endeavor pulls in $132M to back cancer, lung disease drugs

Bio Pharma Dive

Led by the founder of a biotech Celgene acquired for $7 billion, the startup is developing two prospects that originated in the labs of other drugmakers.

Drugs 164
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Ipsen gets grant for treatment of diseases with specific benzothiazepine and benzothiadiazepine derivatives

Pharmaceutical Technology

Discover how Ipsen SA's patented compounds can treat cardiovascular, metabolic, gastrointestinal, and liver diseases. Learn about the method and specific compounds outlined in the recently granted patent.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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[Podcast] Partner for Progress: Strategies for Biotech Success

Bio Pharma Dive

In this three-part podcast series, hear from seasoned experts from Allucent as they discuss a range of topics, including how small and mid-sized companies can take a more strategic approach to pharmacovigilance, a regulatory & development roadmap for ADCs and RDCs, and pre-MAA/NDA inspection readiness.

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Sanofi gets grant for optical decoding system for determining medicament dose in drug delivery device

Pharmaceutical Technology

Enhance medication dosing accuracy with Sanofi's patented optical decoding system for drug delivery devices. Improve efficiency and precision in dispensing with this innovative technology.

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Biogen to invest more in launch of Alzheimer’s drug Leqembi

Bio Pharma Dive

Growing demand has convinced Biogen that it's worth expanding the sales force around Leqembi by 30%.

Sales 183
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Bicycle Therapeutics gets grant for high affinity binders of nectin-4 for treating diseases

Pharmaceutical Technology

Discover the groundbreaking patent by Bicycle Therapeutics Plc for high affinity binders of Nectin-4, including drug conjugates and pharmaceutical compositions. Learn about the detailed method for synthesizing compound BCY8245.

Drugs 130
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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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NeuroSmart Portable MER system paves way for improved treatments in Parkinson’s disease

AuroBlog - Aurous Healthcare Clinical Trials blog

Positive outcomes with brain pacemakers & NeuroSmart Portable MER (micro-electrode recording) system have paved the way for improved treatments in Parkinson’s disease.

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Pfizer gets grant for treatment of cancer using engineered immune cells targeting bcma

Pharmaceutical Technology

Discover how Pfizer's patented CARs targeting BCMA offer a groundbreaking method for treating cancer. Learn about the unique ligand-binding and signaling domains for effective treatment.

Engineer 130
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April 24, 2024: Developments in Waivers and Alterations of Informed Consent in Minimal-Risk Research, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Lauren Milner, Dr. Jonathan Casey, and Dr. Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape.

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EC approves Astellas’ Xtandi for high-risk prostate cancer treatment

Pharmaceutical Technology

The EC has granted approval for label extension to Astellas’ Xtandi to be used as monotherapy or in combination with androgen deprivation therapy to treat adult men with high-risk BCR nmHSPC who are not suitable for salvage-radiotherapy.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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Apellis Pharmaceuticals gets grant for treatment of complement-mediated eye disorder with long-acting compstatin analog

Pharmaceutical Technology

Discover how Apellis Pharmaceuticals' patented method using long-acting compstatin analogs can effectively treat complement-mediated eye disorders like geographic atrophy.

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Elevating Equity: Why National Minority Health Month Matters

XTalks

April marks not only the blossoming of spring and the onslaught of my allergies but also a pivotal moment for raising awareness and advocating for equitable healthcare access. National Minority Health Month, observed annually throughout April, serves to emphasize the recognition of the unique health challenges faced by minority communities. This month-long observance is not just a symbolic gesture; it’s a critical opportunity to take a deeper dive to open up dialogue and cast our focus on

Research 105
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BioCryst Pharmaceuticals gets grant for inhibitors of the complement system for disease treatment

Pharmaceutical Technology

Discover how BioCryst Pharmaceuticals' patent for complement system inhibitors offers targeted treatment options for diseases like paroxysmal nocturnal hemoglobinuria.

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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.

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BMS to Cut 2,200 Jobs in $1.5B Restructuring as Opdivo Sales Drop in Q1

BioSpace

Bristol Myers Squibb announced Thursday it is implementing major cost-cutting measures including thinning out its management layers. The pharma also reported modest revenue growth despite taking a 6% sales hit for lung cancer therapy Opdivo.

Sales 102
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Novartis reports 25% increase in net income in Q1 2024

Pharmaceutical Technology

Novartis has reported net income from continuing operations of $2.68bn for the first quarter (Q1) of 2024, marking a 25% increase from $2.15bn in Q1 2023.

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Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1

BioSpace

Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.

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Novartis bags paediatric FDA label expansion for Lutathera

Pharmaceutical Technology

Lutathera is approved by the US FDA to treat patients aged 12 years and older with rare gastroenteropancreatic neuroendocrine cancer.

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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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Sanders Launches Probe of ‘Outrageously High Prices’ of Novo’s Ozempic, Wegovy

BioSpace

Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags.

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GSK, Lundbeck, ROVI: Three Journeys of Unified Pharma Events Management 

Pharmaceutical Technology

GSK, Lundbeck, and ROVI share how their events strategies contribute to higher-value engagement with healthcare professionals (HCPs).

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Emergence of ADCs as the “hot, new technology”

pharmaphorum

Explore the emergence of ADCs as the "hot, new technology" in the biopharmaceutical industry with companies like ImmunoGen, acquisitioned by AbbVie leading the way. Understand the potential of antibody-drug conjugates and their impact on innovative therapies.

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Investors anticipate “bounce-back” in European private investment

Pharmaceutical Technology

At the Swiss Biotech Day conference, panelists at an investment talk discussed the current state of the Swiss investment landscape.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.