Pharmaceutical Technology
NOVEMBER 8, 2023
For clinical trial providers, the paper-based COA process has been rife with challenges and subject to error. Digitalisation offers a better way.
Bio Pharma Dive
NOVEMBER 8, 2023
A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.
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AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 8, 2023
When people think of foods related to type 2 diabetes, they often think of sugar (even though the evidence for that is still not clear). Now, a new study from the US points the finger at salt.
Bio Pharma Dive
NOVEMBER 8, 2023
The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 8, 2023
The US FDA India Office has proposed to initiate US FDA – Telangana Drugs Control Administration (DCA) Regulatory Forum for future strategic collaborations and initiatives during their recent visit to the Telangana DCA office in Hyderabad.
Bio Pharma Dive
NOVEMBER 8, 2023
CEO Chris Viehbacher said the company has “the elements to think about a return to topline growth.” Yet, that goal hinges on the successful commercialization of multiple new products.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 8, 2023
Company head Bill Anderson said Bayer may separate its consumer health or crop science business, and signaled “significant” layoffs are in the future.
Pharmaceutical Technology
NOVEMBER 8, 2023
Since last year’s COP27 summit, what events and government acts, if any, have made a positive impression on the climate?
Bio Pharma Dive
NOVEMBER 8, 2023
The agency claims intellectual property for emergency allergy shot EpiPen and asthma medication Advair was “improperly listed” in an FDA database.
Pharmaceutical Technology
NOVEMBER 8, 2023
The manufacturer of a prostate cancer imaging agent has struck a deal with the Danish Wiik Pharma to distribute its product across the Nordics.
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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
NOVEMBER 8, 2023
In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In addition, Lilly said it will charge 20% less than Novo for its obesity med in an attempt to provide increased access.
Pharmaceutical Technology
NOVEMBER 8, 2023
OMERS has gained financial upsides for Ultomiris and Monjuvi sales from July 2023, with Xencor retaining a portion of sales-based milestones.
BioSpace
NOVEMBER 8, 2023
Citing manufacturing concerns and formulary losses, Novo Nordisk will discontinue its long-acting insulin Levemir by the end of next year amid strong pressure from U.S. lawmakers to lower insulin prices.
Pharmaceutical Technology
NOVEMBER 8, 2023
With an era of digital transformation promising to optimise pharmaceutical supply chains, how are companies learning to embrace the change?
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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
Fierce Pharma
NOVEMBER 8, 2023
In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. | In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. Now in his fifth month as CEO at struggling conglomerate Bayer, Anderson is focused on an even larger renovation, saying the company is on its way to a “radical realignme
Pharmaceutical Technology
NOVEMBER 8, 2023
NICE is also working on incorporating real-world and AI-generated evidence into medicine evaluation submissions.
BioSpace
NOVEMBER 8, 2023
The vaccine maker is prepared to cut another $300 million in operating expenses in 2024 to keep the company afloat as it works to get its combination COVID-19/flu vaccine into Phase III.
Pharmaceutical Technology
NOVEMBER 8, 2023
Gilead Sciences has posted a net income of $2.17bn for the third quarter (Q3) of 2023 compared with $1.78bn in the same quarter of 2022.
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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.
BioSpace
NOVEMBER 8, 2023
The oral targeted therapy, now sold under the brand name Fruzaqla, is approved for adults with metastatic colorectal cancer who have received certain previous treatments for the disease.
Pharmaceutical Technology
NOVEMBER 8, 2023
The executive order highlights the US sentiment towards AI regulation, but presents a fragmented approach with possibility of discord.
Pharma Times
NOVEMBER 8, 2023
Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 8, 2023
Alfasigma will also gain access to Intercept’s severe alcohol-associated hepatitis (sAH) drug INT-787 currently in a Phase IIa study.
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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.
BioSpace
NOVEMBER 8, 2023
The Federal Trade Commission is challenging over 100 pharmaceutical patents held by prominent drugmakers, including AbbVie, AstraZeneca and Boehringer Ingelheim, for their listings.
Pharmaceutical Technology
NOVEMBER 8, 2023
The company’s cash reduction measures are expected to extend its cash runway into 2026.
Fierce Pharma
NOVEMBER 8, 2023
While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plan | While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plans are for future growth, he said on a call with investors.
Pharmaceutical Technology
NOVEMBER 8, 2023
At the BIO-Europe conference, early-stage investors highlighted the importance of translational funding in a risk-averse climate.
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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.
BioSpace
NOVEMBER 8, 2023
Newer hiring models based on skills applicants have learned and their general potential for growth could avoid the drawbacks of relying on degrees and experience.
Pharmaceutical Technology
NOVEMBER 8, 2023
Menarini has signed an agreement with SciClone for the development and commercialisation of Orserdu (elacestrant) in China.
BioSpace
NOVEMBER 8, 2023
While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings.
Pharmaceutical Technology
NOVEMBER 8, 2023
Dewpoint Therapeutics and Evotec have partnered for the research and development of oncology programmes comprising c-mods.
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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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