Bio Pharma Dive
AUGUST 4, 2023
The surprise rejection of a high-dose form of Eylea could be resolved earlier than anticipated. But some of the company’s pipeline projects have stumbled.
Pharmaceutical Technology
AUGUST 4, 2023
Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.
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Rethinking Clinical Trials
AUGUST 4, 2023
Swimming with the Sharks: Translation of Pragmatic Trial Results Description Dr. Greg Simon discussing translating pragmatic clinical trial results. Biography Gregory Simon, MD, MPH Senior Investigator, Kaiser Permanente Washington Health Research Institute SPOT Demonstration Project PI Health Care Systems Interactions Core Chair Related View more content from the Disseminating, Implementing, and Sustaining Evidence-Based Practices into Clinical Care: NIH-Hosted Workshop.
Pharmaceutical Technology
AUGUST 4, 2023
The US FDA has granted approval for an expanded indication of Merck’s Ebola vaccine, Ervebo, for usage in the paediatric population.
Bio Pharma Dive
AUGUST 4, 2023
The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.
Pharmaceutical Technology
AUGUST 4, 2023
Gilead Sciences has posted net income of $1.03bn in Q2 of 2023 compared with $1.13bn in the same quarter of the previous year, a dip of 8.45%.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 4, 2023
BlueRock Therapeutics signed an agreement with bit.bio to discover and manufacture iPSC-derived regulatory T cells (Tregs) based therapies.
Antidote
AUGUST 4, 2023
One of the key challenges in medical research is successful patient enrollment. It is not uncommon for trials to fall behind schedule due to low patient engagement — but by creating a recruitment and enrollment strategy centered on patient-centricity , more successful research processes can be made possible. Below, we are exploring some of the top ways to do just that.
Pharmaceutical Technology
AUGUST 4, 2023
Cellectis provided updates for the three CAR-T cell therapies trials, with the three trials recruiting across various cancer indications.
Intouch Solutions
AUGUST 4, 2023
Every quarter, EVERSANA INTOUCH employees gather for a town hall coined “Faruk (and friends) Answers Questions” (FAQ). Faruk Capan, CEO, EVERSANA INTOUCH and Chief Innovation Officer, EVERSANA, hosts this virtual forum alongside agency leaders to provide employee and team recognition, business updates, cultural initiatives and more. What makes this quarterly town hall unique from others is the transparent format of the FAQ.
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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
AUGUST 4, 2023
Hipra’s Bimervax targets the alpha and beta viral variants, but the EMA recently said it seeks vaccines designed against XBB 1.5 Omicron.
Outsourcing Pharma
AUGUST 4, 2023
Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage them and is an important part of clincal trials.
Pharmaceutical Technology
AUGUST 4, 2023
The healthcare domain is growing by leaps and bounds, with contributing factors such as the growing adoption of remote patient…
BioPharma Reporter
AUGUST 4, 2023
Scientists at a major US hospital have developed a âcancer-killing pillâ that appears to âannihilateâ solid tumors through targeted chemotherapy.
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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
AUGUST 4, 2023
Mesoblast plans follows an FDA response to the BLA resubmission for remestemcel-L for treating pediatric steroid-refractory acute GvHD.
Pharma Times
AUGUST 4, 2023
Research is evaluating the company’s novel investigational FKRP gene replacement therapy - News - PharmaTimes
Pharmaceutical Technology
AUGUST 4, 2023
Evox and the Icahn School of Medicine will develop gene delivery vectors for cardiomyocytes for heart disease treatments.
Fierce Pharma
AUGUST 4, 2023
In a bid to thwart shortages of critical hospital drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. | In a bid to thwart shortages of critical drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. The move comes after a tornado hit the company's injectables facility late last month, creating questions about potential supply disruptions.
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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
AUGUST 4, 2023
This week, people are tweeting about Purdue's ongoing bankruptcy case, pandemic preparedness and healthcare AI.
Fierce Pharma
AUGUST 4, 2023
And the hits just keep on coming for Galapagos. | Based on the results of a phase 3 study, Galapagos has decided not to submit a Marketing Authorization Application in Europe for Jyseleca (filgotinib) in Crohn’s disease. The company also will not proceed with its application for filgotinib in ulcerative colitis in Switzerland. Galapagos revealed the moves in reporting its first-half earnings.
Pharma Times
AUGUST 4, 2023
Therapy is a treatment option for adults with severe and moderately severe haemophilia B - News - PharmaTimes
Drug Channels
AUGUST 4, 2023
Today’s guest post comes from Jonas Boli, Chief Product Officer at Phil, Inc. Jonas describes the challenges patients face when accessing specialty therapies and explains how patient abandonment affects manufacturers over time. He argues that an effective telemedicine program can help patients via an end-to-end digital experience. To learn more, register for Phil’s free webinar on August 29th at 2 p.m.
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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.
Fierce Pharma
AUGUST 4, 2023
In January, when Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunol | When Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse.
XTalks
AUGUST 4, 2023
The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks. The Trader Joe’s recall has raised some eyebrows, with food safety experts calling it a serious concern.
Fierce Pharma
AUGUST 4, 2023
In their ongoing RET inhibitor rivalry, Eli Lilly is pulling further ahead of Blueprint Medicines, even as the latter company is being abandoned by Roche. | In their ongoing RET inhibitor rivalry, Eli Lilly is pulling further ahead of Blueprint Medicines, even as the latter company is being abandoned by Roche.
pharmaphorum
AUGUST 4, 2023
Dosing prompts Novartis to tap Ionis for second Lp(a) drug Phil.
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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
AUGUST 4, 2023
Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Abbvie Inc drug ORILISSA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
AUGUST 4, 2023
News round-up for 31 July – 4 August by DDW Digital Content Editor Diana Spencer. The pace of innovation in cancer drug discovery showed no signs of slowing this week, with several pretty momentous discoveries boosting research in the sector. These include the creation of a compound that can block the spread of cancer and the discovery that PARP inhibitors could be effective in a new group of patients.
Drug Patent Watch
AUGUST 4, 2023
Annual Drug Patent Expirations for ORIAHNN+%28COPACKAGED%29 Oriahnn (copackaged) is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are five… The post New patent for Abbvie Inc drug ORIAHNN (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
AUGUST 4, 2023
Charles River Laboratories has revealed plans to open Charles River Accelerator and Development Lab (CRADL) locations in Seattle and Philadelphia, expanding the company’s contract vivarium space for the biopharmaceutical industry. CRADL Seattle is opening this September as Charles River’s most recent investment in Seattle, providing flexible vivarium space and on-demand in vivo study support services.
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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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