Pharmaceutical Technology
SEPTEMBER 19, 2024
An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.
Bio Pharma Dive
SEPTEMBER 19, 2024
Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.
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AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 19, 2024
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Bio Pharma Dive
SEPTEMBER 19, 2024
According to the company, the results are the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 trial.
Pharmaceutical Technology
SEPTEMBER 19, 2024
Accord BioPharma received FDA approval for 420mg HERCESSI, a biosimilar to Herceptin to treat various kinds of HER2-overexpressing cancers.
Bio Pharma Dive
SEPTEMBER 19, 2024
In a letter to CEO Anne Wojcicki, the directors said they’d resign “rather than have a protracted and distracting difference of view with you” about the company’s future.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
SEPTEMBER 19, 2024
GC Therapeutics claims it can create off-the-shelf therapies from induced pluripotent stem cells faster than by current methods with a simpler process.
Pharmaceutical Technology
SEPTEMBER 19, 2024
NanoVation will receive $600m in upfront cash and potential milestone payments, as well as tiered royalties on future product sales.
Bio Pharma Dive
SEPTEMBER 19, 2024
Shares dropped by as much as one-quarter Thursday after the biotech shared longer-term results for a gene therapy it’s developing for wet AMD.
Pharmaceutical Technology
SEPTEMBER 19, 2024
Lupin has announced a non-exclusive patent licence agreement with Takeda for the commercialisation of Vonoprazan Tablets in India.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
SEPTEMBER 19, 2024
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.
Pharmaceutical Technology
SEPTEMBER 19, 2024
As part of the acquisition, Organon will acquire psoriasis treatment Vtama, which could soon be approved in atopic dermatitis.
Drug Patent Watch
SEPTEMBER 19, 2024
The generic drug market in the United States is characterized by significant price volatility and shortages, driven by the structure of the market and the incentives for manufacturers. To address these issues, several market-based proposals have been put forth to optimize generic drug cost and availability.
Pharmaceutical Technology
SEPTEMBER 19, 2024
The US FDA has granted approval for MSD’s KEYTRUDA regimen as a first-line treatment for malignant pleural mesothelioma (MPM).
pharmaphorum
SEPTEMBER 19, 2024
Explore how the pharmaceutical industry is ensuring supply chain resilience to maintain consistency despite global events. Learn more about strategies and practices implemented to address challenges and ensure reliable delivery of pharmaceutical products.
Pharmaceutical Technology
SEPTEMBER 19, 2024
Gavi has entered into an agreement with Bavarian Nordic to secure 500,000 doses of the MVA-BN mpox vaccine.
Outsourcing Pharma
SEPTEMBER 19, 2024
The series A financing will enable Nura Bio to advance its lead drug candidate into the next stage of clinical trials, shortly after successfully completing a first phase 1 clinical trial.
Pharmaceutical Technology
SEPTEMBER 19, 2024
Statistics show incidences of cancer are rising in younger demographics.
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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.
pharmaphorum
SEPTEMBER 19, 2024
Upstream Bio has become the latest biotech to chance its arm with a public listing in the US, seeking funds for its rival to respiratory drug Tezspire.
Fierce Pharma
SEPTEMBER 19, 2024
Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma. | Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.
pharmaphorum
SEPTEMBER 19, 2024
Neuralink gets FDA breakthrough status for an implantable chip called Blindsight that promises to restore eyesight to the blind
Fierce Pharma
SEPTEMBER 19, 2024
A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.
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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
Outsourcing Pharma
SEPTEMBER 19, 2024
The Hong Kong headquartered company says its idiopathic pulmonary fibrosis drug performed well in a phase 2a trial and met its primary endpoint.
pharmaphorum
SEPTEMBER 19, 2024
ICER will preempt the next Medicare drug pricing round with a 'special report' on two COPD drugs from GSK
BioPharma Reporter
SEPTEMBER 19, 2024
Although vaccines already exist to prevent mpox, high prices and the risk of side effects make it difficult to roll them out in the regions that need them most. Vaccine developers are working to offer better options.
pharmaphorum
SEPTEMBER 19, 2024
FDA turns down Vanda Pharma's tradipitant for gastroparesis, prompting a furious response from the company
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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.
Drug Discovery World
SEPTEMBER 19, 2024
Arsenal Biosciences has closed an oversubscribed $325 million Series C financing round to support its development of CAR T-cell therapies for solid tumours. The funding round included new investors ARCH Venture Partners, Milky Way Investments Group, Regeneron Ventures, NVentures (NVIDIA’s venture capital arm), Luma Group, funds and accounts advised by T Rowe Price Associates, Rock Springs Capital, among others.
pharmaphorum
SEPTEMBER 19, 2024
Daiichi Sankyo's FLT3 inhibitor Vanflyta has been recommended for NHS use as a treatment for a specific form of acute myeloid leukaemia (AML) in England and Wales, the first countries in Europe to authorise use of the drug after a health technology assessment (HTA) review.
ACRP blog
SEPTEMBER 19, 2024
In recognition of September being World Alzheimer’s Month (a campaign of Alzheimer’s Disease International), ACRP sought out commentary on a type of therapy for the disease that’s not as well known to the public as the recently approved pharmaceuticals lacanemab (Leqembi® from Eisai Inc. and Biogen) or donanemab (Kisunla™ from Eli Lilly), or the much older mematine (now marketed under many brand names worldwide).
Drug Discovery World
SEPTEMBER 19, 2024
Scientists have pinpointed thousands of genetic changes in a gene that may increase a person’s risk of developing breast and ovarian cancer and also identified new potential therapeutic targets. Researchers from the Wellcome Sanger Institute and their collaborators focused on the ‘cancer protection’ gene RAD51C, known to increase ovarian cancer risk six-fold and risk of aggressive subtypes of breast cancer four-fold.
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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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