Bio Pharma Dive
AUGUST 17, 2023
A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 17, 2023
There’s a small fatty gland that sits behind your sternum and is often said to be ‘useless’ in adulthood.
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Rethinking Clinical Trials
AUGUST 17, 2023
When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. To address these questions, the American Journal of Bioethics ( AJOB ) recently published commentaries on 2 target articles in a special issue on pragmatic clinical trials.
Bio Pharma Dive
AUGUST 17, 2023
The German pharmaceutical company is launching three Phase 3 trials of an obesity drug called survodutide, which like Wegovy targets the GLP-1 receptor
Pharmaceutical Technology
AUGUST 17, 2023
Priority counties in Africa and Asia will soon receive state-of-the-art laboratories, new genome-sequencing technology, and a strengthened workforce.
Bio Pharma Dive
AUGUST 17, 2023
The mixed results supporting the treatment, Sohonos, have proven a tough case for regulators and led to different outcomes in the U.S. and Europe.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 17, 2023
The Department Related Parliamentary Standing Committee on Health and Family Welfare has reiterated its stand that the inter-ministry coordination for promotion of the medical devices industry should be done by the ministry of health and family welfare (MoHFW).
Pharmaceutical Technology
AUGUST 17, 2023
The US Circuit Court of Appeals restricted the prescription of abortion pills, following action from several anti-abortion groups.
XTalks
AUGUST 17, 2023
New Culture, one of several emerging startups using precision fermentation to produce casein proteins, has scaled up its fermentation process to now make manufacturing volumes, specifically for its animal-free mozzarella. The company is confident that it can scale up while maintaining price parity with traditional mozzarella within the next three years.
Pharmaceutical Technology
AUGUST 17, 2023
BriaCell Therapeutics has received a research grant from NCI to accelerate the development of its immunotherapies cancer platform.
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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
Drug Patent Watch
AUGUST 17, 2023
Annual Drug Patent Expirations for LUMASON Lumason is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Bracco drug LUMASON appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 17, 2023
Ipsen has received approval from the US FDA for its Sohonos to treat people with fibrodysplasia ossificans progressiva
Outsourcing Pharma
AUGUST 17, 2023
The UKâs Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombliti + Opfolda, a two-component therapy to treat Pompe disease.
Pharmaceutical Technology
AUGUST 17, 2023
Eli Lilly is enlarging its drug pipeline with major acquisitions following second quarter financial statements.
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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
BioPharma Reporter
AUGUST 17, 2023
BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers and shakers in the pharma industry. From Karuna Therapeutics to IO Biotech, we break down the key changes on the pharmaceutical job ladder.
Pharma Times
AUGUST 17, 2023
The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study - News - PharmaTimes
Fierce Pharma
AUGUST 17, 2023
Despite all the upheaval in the pharma industry over the last few years, many familiar names will remain at the top of the industry's sales charts toward the end of the decade. | Merck cancer superstar Keytruda is projected to be the world’s top selling drug by a huge margin in 2028, according to a report by Evaluate. On its list of top 10 drugs by sales in 2028, Keytruda is expected to top the $30 billion mark, with no other therapy predicted to reach $20 billion in sales.
BioPharma Reporter
AUGUST 17, 2023
Absci, a leader in AI drug creation, and the California Institute of Technology (Caltech) have received a grant from the Bill & Melinda Gates Foundation.
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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.
Fierce Pharma
AUGUST 17, 2023
As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company's long-acting HIV prevention drug, Apretude, | The advocacy organization has been trying to lock down supplies of ViiV's long-acting Apretude for more than a year. Now, it's asking the HIV-focused company to remove recently added clauses in the contract that it says derail transparency.
BioSpace
AUGUST 17, 2023
The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab-bbfg) makes it the first and only treatment indicated for children and adults with CHAPLE disease.
Fierce Pharma
AUGUST 17, 2023
Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. | In a Tuesday filing in New Jersey Federal Court, lawyers for several states urged U.S. District Judge Brian Martinotti to delay the approval of Lilly's proposed $13.5 million settlement unless it’s altered to make sure states can still file their own insulin pricing lawsuits.
BioSpace
AUGUST 17, 2023
The company is continuing its renal cell carcinoma push for its oral HIF-2α inhibitor Welireg with promising Phase III data showing significant progression-free survival improvements in patients.
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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 17, 2023
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. | As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna.
BioSpace
AUGUST 17, 2023
After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.
Fierce Pharma
AUGUST 17, 2023
On a long road full of potholes, Ipsen has reached its destination—gaining FDA approval for Sohonos to treat an ultra-rare bone disease.
Pharma Times
AUGUST 17, 2023
The therapy involves long-term enzyme replacement therapy for aduls with Fabry disease - News - PharmaTimes
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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.
Fierce Pharma
AUGUST 17, 2023
In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. | Bayer is providing a cash donation of $250,000 to Maui, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said Wednesday. The Hawaiian island has been devastated by wildfires this month.
BioSpace
AUGUST 17, 2023
The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.
Fierce Pharma
AUGUST 17, 2023
Johnson & Johnson and Legend Biotech's Carvykti keeps growing despite a newly launched off-the-shelf option. | J&J and Legend Biotech's Carvykti kept growing despite a newly launched off-the-shelf option. Novo Holdings joined a $290 million investment in a Chinese R&D product and service provider. China is stressing biotech as a “major focus” as the country tries to woo foreign investment.
BioSpace
AUGUST 17, 2023
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
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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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