Mon.Apr 15, 2024

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Pfizer, BioNTech win pause in patent infringement case from rival Moderna

Fierce Pharma

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Novartis touts surrogate endpoint win, nabs priority review for Fabhalta in IgAN

Fierce Pharma

A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.

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Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Boehringer Ingelheim leans on late-stage pipeline, plots 25 new launches over the next decade

Fierce Pharma

Boehringer Ingelheim’s 2023 was largely marked by the highly anticipated launch of its Cyltezo, the first interchangeable biosimilar to AbbVie’s Humira. | The company's late-stage pipeline focuses on oncology, cardiorespiratory diseases, mental health and cardiovascular-renal-metabolic conditions. Boehringer looks to kick off ten new phase 2 and 3 trials in the next 12-18 months, it said in its earnings release.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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Regeneron launches $500m venture capital arm

pharmaphorum

Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.

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Marinus faces share-price collapse, weighs 'cost-saving strategies' after IV seizure med comes up short

Fierce Pharma

Marinus Pharmaceuticals’ attempt to expand the use of its seizure medicine in a new formulation has hit a pothole. | Marinus Pharmaceuticals’ attempt to expand the use of its seizure medicine in a new formulation has hit a pothole. As a result, the company is “evaluating potential cost-saving strategies,” CEO Scott Braunstein, M.D., said in a release.

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Why Banner Health Is Scaling Automation Tech In Its Operating Rooms

MedCity News

Banner Health is deploying Qventus’ perioperative technology across the entire organization following the success of an initial pilot. The software integrates with EHRs and uses machine learning to automate operating room scheduling processes and maximize surgical caseloads. The post Why Banner Health Is Scaling Automation Tech In Its Operating Rooms appeared first on MedCity News.

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Roche eyes earlier treatment nod after Columvi-chemo trial win in 2nd-line lymphoma

Fierce Pharma

As Genentech bolsters its hematology portfolio with new antibody drugs and bispecifics, the Roche unit has revealed a trial win that could push its recently approved T-cell engager Columvi int | The study paired Columvi, a CD20xCD3 bispecific T-cell engager, with the chemotherapy GemOx (glofitamab-gxbm) in patients who’d tried at least one prior line of therapy and did not qualify for autologous stem cell transplants.

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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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Activist hedge fund seeks big shake-up at Novavax

pharmaphorum

Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.

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The New Authenticity: SXSW 2024 Insights, Part 2

Eversana Intouch

At SXSW 2024, amidst a confluence of marketing, technology, AI, and design, one word seemed to echo through every conversation, panel, and workshop: authenticity. It’s fascinating, isn’t it? The idea of being genuine, real, and true — qualities so deeply sought after in everything we do, yet so complex and rich when we pause to unpack them. Among the minds at EVERSANA INTOUCH, with leaders spanning the spectrum from Strategic Planning to Creative Direction, and from Experience Design to Customer

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Healthware re-launches as Eversana Intouch full service affiliate

pharmaphorum

Life sciences service provider (and pharmaphorum parent company) Eversana has completed the integration of Healthware Group, the Italy-based global agency and consultancy it acquired in October. The group will now be known as Eversana Intouch Healthware and will operate as Eversana’s sixth full-service affiliate.

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Trial Findings for Minimally Invasive Parafascicular Technology Show Promise for Intracerebral Hemorrhage Treatment

Pharmaceutical Commerce

Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.

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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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After ph3 win, Roche eyes earlier use of Columvi in DLBCL

pharmaphorum

Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.

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Long-term data indicates “significant” potential of aGvHD microbiome treatment

European Pharmaceutical Review

Positive data from MaaT Pharma’s Microbiome Ecosystem Therapy TM (MET) MaaT013 as a treatment for acute graft-versus-host disease (aGvHD), is set to be presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting. Based on the long-term survival data, at 18 months MaaT013 enabled 42 percent overall survival in all patients and 58 percent in responder patients.

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Study warns of chronic kidney disease timebomb

pharmaphorum

Up to one in six people in eight industrialised nations could be suffering from chronic kidney disease (CKD) by 2032, with dire consequences for “patients, [the] planet, and economies,” says a new study.

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Francis Crick researchers reveal pathways linking intestinal inflammation and colitis

PharmaTimes

Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis

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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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Fujifilm plans $1.2 billion investment in major US manufacturing facility

European Pharmaceutical Review

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

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Nine UCL researchers secure £560m in research funding from ERC

PharmaTimes

Approximately 14% of the competition-submitted proposals were selected to receive funding

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Seasonal variation of microbial contamination in pharmaceutical cleanrooms

European Pharmaceutical Review

Researchers investigating environmental microbial contamination found “no seasonal climatic influences were observed” in bacteria and fungi counts present in Grade D (ISO 8) Brazilian pharmaceutical cleanrooms. Samples were obtained via surface and air monitoring over a one-year period. While microbial levels were predicted to be higher during rainy periods compared to dry spells, “no statistically significant differences in bacteria and fungi counts were found between months or seasonal period

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From skepticism to strategy: How AI is transforming the IP practice

Clarivate

Artificial intelligence (AI) is evolving rapidly with new business use cases constantly emerging. So, how do law firms and in-house counsels ensure they don’t get left behind? Our research found that IP professionals are currently grappling with what AI could mean for them, their practice and their processes. They are keen to realize benefits but are largely skeptical about AI deployment with relatively low industry adoption.

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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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ebook: Twin-screw extrusion for pharmaceutical applications

European Pharmaceutical Review

Hot-melt extrusion can help overcome many pharmaceutical formulation challenges since it is a straightforward technique to compound all excipients on a molecular level. Various dosage forms can be produced with a twin-screw extruder and corresponding downstream equipment. These include solid oral dosage forms such as buccal and transdermal, as well as new delivery systems like subcutaneous implants and transmucosal applications.

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ImmunityBio gets grant for cross-reactive SARS-COV2 vaccine composition for multiple coronaviruses

Pharmaceutical Technology

Discover ImmunityBio Inc's groundbreaking patent for a cross-reactive SARS-CoV2 vaccine targeting multiple variants. Learn how this innovative method boosts immune response and memory cells for enhanced protection.

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Pharma Pulse 4/15/24: Increase in ransomware attacks to healthcare's remote access systems, The Health and Healthcare of Gen Xers & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Genzyme gets grant for method for reducing interference in drug assay due to antibodies

Pharmaceutical Technology

Discover Genzyme Corp's innovative method for detecting anti-drug antibodies in human body fluids. Learn how their patented process reduces interference in drug assays effectively.

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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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Maneuvering the Rapid Demand

PharmExec

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses why their drug isn't experiencing the same supply issues as the bigger names in the space.

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Ginkgo BioWorks gets grant for AAV vector for treating NPC1 with specific gene sequence

Pharmaceutical Technology

Discover the groundbreaking gene therapy patent by Ginkgo BioWorks Inc for treating NPC1 using AAV vectors. Learn how this innovative approach offers hope for rare genetic disorders like Neimann-Pick Disease Type C.

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Fighting for Innovation

PharmExec

Damien Bailly, president of established markets at Astellas, discusses why partnerships and collaborations are a critical organizational—and wider ecosystem—imperative in ensuring that patients have access to the medicines they need.

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Zydus Lifesciences gets grant for oral suspension pharmaceutical composition of immunosuppressive agent

Pharmaceutical Technology

Discover the innovative patent by Zydus Lifesciences Ltd for a pharmaceutical composition in oral suspension form, enhancing stability and palatability for immunosuppressive agents.

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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.