Mon.Apr 15, 2024

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Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations

Worldwide Clinical Trials

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. In fact, recent industry dynamics indicate a considerable shift in preference towards midsize CROs, driven by the need for more personalized, agile, and cost-effective partnerships.

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Ultragenyx says Angelman therapy is working, but safety questions remain

Bio Pharma Dive

Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

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Francis Crick researchers reveal pathways linking intestinal inflammation and colitis

Pharma Times

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

Research 149
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Roche reports survival data for new dual-acting lymphoma drug

Bio Pharma Dive

The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.

Medicine 287
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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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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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Keeping cleanrooms clean: Choosing the right laboratory equipment is key

Bio Pharma Dive

Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.

More Trending

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The growing role for cfHPV-DNA testing in OPSCC therapeutic development

Bio Pharma Dive

Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.

DNA 264
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Marinus fails to meet early stopping criteria for status epilepticus trial

Pharmaceutical Technology

The future development of IV ganaxolone will be determined by results from the Phase III RAISE study, expected in summer 2024.

Trials 130
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Regeneron commits $500M to new venture capital fund

Bio Pharma Dive

While corporate venture arms are commonplace among pharmaceutical companies, the new fund announced Monday is Regeneron’s first.

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Soligenix bags orpan drug designation for Marburg virus vaccine

Pharmaceutical Technology

Soligenix’s Marburg virus vaccine demonstrated 100% protection in non-human primates in a clinical study.

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

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Neumora’s schizophrenia drug hit with clinical hold

Bio Pharma Dive

Shares of the biotech dipped by double digits following disclosure the FDA had paused an early-stage study of Neumora’s muscarinic-targeting drug.

Drugs 173
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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.

Antibody 130
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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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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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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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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.

Protein 124
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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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Nine UCL researchers secure £560m in research funding from ERC

Pharma Times

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

Research 124
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Ablynx gets grant for inhibiting tumor growth by administering polypeptides binding gitr

Pharmaceutical Technology

Enhance immune response and inhibit tumor growth with Ablynx NV's patented immunoglobulin single variable domains targeting GITR. Explore the potential for cancer treatment and pharmaceutical compositions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Psychedelic treatments on cusp of approval, but questions remain

pharmaphorum

Psychedelic treatments for conditions like PTSD using substances like MDMA are on the brink of approval, but there are still unanswered questions surrounding their effectiveness and potential risks. Learn more here.

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Arena Pharmaceuticals gets grant for treatment of atopic dermatitis with compound 1

Pharmaceutical Technology

Discover the groundbreaking patent by Arena Pharmaceuticals for treating atopic dermatitis with a specific compound in a standard dose. Learn how (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid can revolutionize dermatological treatments.

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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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Ferring International Center gets grant for pharmaceutical composition for treating inflammatory bowel disease using bacteriophages

Pharmaceutical Technology

Discover a groundbreaking pharmaceutical composition with patented bacteriophages targeting E. coli strains in treating inflammatory bowel disease. Explore the innovative approach to combatting infections caused by adherent-invasive E. coli.

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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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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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Allscripts Healthcare Solutions gets grant for resource management system for medical software applications optimization

Pharmaceutical Technology

Optimize and distribute predictively processed data in medical software applications with Allscripts Healthcare Solutions Inc's patented resource management system. Enhance operational capabilities and capacities for improved performance.

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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.

Antibody 110
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AVEO Pharmaceuticals gets grant for decreasing blood urea nitrogen levels in hyperuricemia using anti-gdf15 antibody

Pharmaceutical Technology

Discover a groundbreaking method to treat renal disorders with AVEO Pharmaceuticals Inc's patented anti-GDF15 antibody. Learn how this innovative approach targets hyperuricemia and CKD for improved renal function.

Antibody 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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The New Authenticity: SXSW 2024 Insights, Part 2

Intouch Solutions

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

Marketing 105
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Advancing medicine requires more secure supply chains

pharmaphorum

The advancement of medicine is dependent on secure pharmaceutical supply chains. Discover why ensuring the security of these chains is crucial for the development and distribution of life-saving medications.

Medicine 105
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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.

Trials 105
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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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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.