Bio Pharma Dive
MAY 3, 2024
Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.
Pharmaceutical Technology
MAY 3, 2024
UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.
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Bio Pharma Dive
MAY 3, 2024
The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.
Pharmaceutical Technology
MAY 3, 2024
The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.
Bio Pharma Dive
MAY 3, 2024
Conversations at this year's J.P. Morgan Healthcare Conference led to a $1 billion buyout that Mariana's CEO described as a "perfect marriage.
Pharmaceutical Technology
MAY 3, 2024
Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 3, 2024
The NHS in the UK has announced plans to offer Pfizer's Voxelotor (Oxbryta), a new treatment option for sickle cell disease.
pharmaphorum
MAY 3, 2024
Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim
Pharmaceutical Technology
MAY 3, 2024
Amgen announced updates in the obesity space, with topline data for MariTide expected in late 2024.
Fierce Pharma
MAY 3, 2024
Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. | Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. Federal Trade Commission has teed up a further extension on the deal’s review period.
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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
Pharmaceutical Technology
MAY 3, 2024
Techniques such as rapid nanomotion-based susceptibility testing, and MALDI-TOF-MS could be used to identify resistance mechanisms of several deadly organisms.
pharmaphorum
MAY 3, 2024
Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials
Pharmaceutical Technology
MAY 3, 2024
Operations managers get the longest-term value from technology by letting it work for them step-by-step, as a sustainable optimiser
XTalks
MAY 3, 2024
How common is Salmonella in chicken? This question becomes crucial as the US Department of Agriculture (USDA) mandates lower Salmonella levels in certain frozen chicken items. To combat food poisoning, US agriculture officials introduced a final rule last Friday, mandating significant reductions in Salmonella bacteria in specific chicken products. Starting in 2025, high levels of Salmonella in frozen breaded and stuffed chicken products will classify them as adulterated.
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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
Pharmaceutical Technology
MAY 3, 2024
Despite failing to get an approval for type 1 diabetes in 2019, Lexicon plans to resubmit its NDA to the FDA by mid-2024.
Fierce Pharma
MAY 3, 2024
During the Q&A portion of Amgen’s quarterly conference call Thursday, eight of the first nine questions were about the company’s investigational efforts in obesity. | The buzz about Amgen’s obesity prospects overshadowed the company’s solid work on the top line as revenue came in at $7.4 billion for a 22% increase. Much of the boost can be attributed to sales of products acquired in Amgen’s $27.8 billion buyout of Horizon Therapeutics, which was completed early in the fourth quarter of last
Pharmaceutical Technology
MAY 3, 2024
ImmunityBio has entered a worldwide agreement with the Serum Institute of India to secure a supply of BCG vaccine for all cancer types.
Fierce Pharma
MAY 3, 2024
Watch out, Incyte. Leo Pharma and its JAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura. | Leo Pharma's delgocitinib, which the company calls a potential growth driver, could shake up the topical JAK market and put pressure on Incyte's approved Opzelura.
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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.
Pharmaceutical Technology
MAY 3, 2024
BridgeBio Pharma has announced the launch of BridgeBio Oncology Therapeutics (BBOT), underpinned by $200m of private external capital.
pharmaphorum
MAY 3, 2024
Some NHS patients in the UK will finally be able to access Pfizer’s sickle cell disease therapy Oxbryta after agreement was reached on a price cut
Pharma Times
MAY 3, 2024
The INTerpath-001 trial is evaluating Moderna/Merck’s mRNA-4157 in combination with Merck’s Keytruda
Fierce Pharma
MAY 3, 2024
GSK defends itself—again—after senator argues it withdrew popular asthma med to dodge price caps and Medicaid rebates fkansteiner Fri, 05/03/2024 - 09:54
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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.
Pharma Times
MAY 3, 2024
Neurological disorders, such as epilepsy or chronic pain, affect over three billion people worldwide
pharmaphorum
MAY 3, 2024
AI-powered home healthcare model from Cera could save NHS and UK £1bn in 2026 if adopted nationwide, says new study
Pharmaceutical Commerce
MAY 3, 2024
The latest news for pharma industry insiders.
pharmaphorum
MAY 3, 2024
Donor recruitment and recallability remain key challenges for the disease research community. This post breaks down strategies to engage more healthy donors and boost recall rates.
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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 Patent Watch
MAY 3, 2024
Annual Drug Patent Expirations for MYRBETRIQ+GRANULES Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier.
Drug Discovery World
MAY 3, 2024
News round-up for 29 April – 3 May by DDW Multimedia Editor Megan Thomas. The ongoing innovation and development in the drug discovery sector relies on a number of moving parts, one of which is financial support and backing. Whether it is successful seed funding or dedicated investment, this money enables scientists to produce top-quality research which will in turn result in discoveries and drugs that help tackle disease and areas of unmet need.
Drug Patent Watch
MAY 3, 2024
Annual Drug Patent Expirations for OXBRYTA Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. It is available from one supplier.
Velocity Clinical Research
MAY 3, 2024
Merck recently presented Velocity’s Hallandale Beach site with the Significant Contribution to Clinical Trials Award, specifically for being the top enroller of diverse participants in cardiovascular clinical trials in 2023. We’re grateful for the contributions of our Hallandale Beach site toward improving diversity in clinical trials, both in the workforce and in our participants.
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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.
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