FDA grants approval for Novartis’ hidradenitis suppurativa treatment
Pharmaceutical Technology
NOVEMBER 1, 2023
The US FDA has granted approval for Novartis’ Cosentyx to treat adult patients with moderate to severe hidradenitis suppurativa (HS).
Wed.Nov 01, 2023
264 
How Old Are Your Eyes? New ‘Clock’ Could Reveal Disease Risk
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 1, 2023
Scientists have developed a new tool for determining the age of eye cells without sampling regenerative tissue, which could make treatments for eye disease more personalized and better targeted. The team, led by researchers from Stanford University, adapted a technique used for analyzing eye fluid.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pfizer posts reported net loss of $2.38bn for Q3 2023
Pharmaceutical Technology
NOVEMBER 1, 2023
Pfizer has posted a net loss of $2.38bn in Q3 2023 compared to a net income of $8.61bn during the same period of 2022.
DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 1, 2023
The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.
November 1, 2023: Special Biostatistics Series Continues With Complex Clustering in Pragmatic Trials
Rethinking Clinical Trials
NOVEMBER 1, 2023
In this Friday’s PCT Grand Rounds, Jonathan Moyer of the NIH Office of Disease Prevention will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “The Perils and Pitfalls of Complex Clustering in Pragmatic Trials.” The session will be held on Friday, November 3, at 1:00 pm eastern and will be moderated by Andrea Cook.
GSK outpaces Pfizer in RSV vaccine market
Bio Pharma Dive
NOVEMBER 1, 2023
Sales of GSK’s new RSV shot Arexvy were more than double what Pfizer reported for its rival product, suggesting substantial demand this fall.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Bioluminescence Ventures debuts with $477M to speed up drug discovery
Bio Pharma Dive
NOVEMBER 1, 2023
The San Francisco-based venture capital firm has already invested in precision medicine as well as cell and gene therapy.
ONL Therapeutics seeks upto $100m to further eye disease pipeline
Pharmaceutical Technology
NOVEMBER 1, 2023
ONL Therapeutics plans to raise $75-$100m to support Phase II trials in geographic atrophy and open-angle glaucoma.
Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep. 134
XTalks
NOVEMBER 1, 2023
This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and d
Kite and Epic Bio partner to develop new cancer cell therapies
Pharmaceutical Technology
NOVEMBER 1, 2023
Kite has signed agreement with Epic Bio for the development of new cancer cell therapies leveraging the latter’s gene regulation platform.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Merck’s Keytruda Plus Chemo Secures FDA Approval for Biliary Tract Cancer
BioSpace
NOVEMBER 1, 2023
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.
Signal: Abcam likely to be sold as founder suspends bid to block takeover
Pharmaceutical Technology
NOVEMBER 1, 2023
Johnathan Milner suspended his vote against campaign today in the wake of "extensive feedback" from Abcam shareholders.
Novartis' Cosentyx beats UCB drug to finish line as first new biologic for lesser-known skin condition in years
Fierce Pharma
NOVEMBER 1, 2023
Cosentyx may soon share the hidradenitis suppurativa (HS) field with another inflammatory biologic—but, for now, the Novartis drug has a head start. | The FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa in adults, Novartis said Tuesday. The green light makes Cosentyx the first new biologic to treat the lesser-known skin affliction in nearly a decade.
GSK and Arrowhead sign deal for Janssen’s JNJ-3989
Pharmaceutical Technology
NOVEMBER 1, 2023
GSK and Arrowhead Pharmaceuticals have signed an agreement for Johnson & Johnson company Janssen Pharmaceuticals’ JNJ-3989.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
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
AI tools to speed up lung cancer diagnosis in NHS hospitals
Pharma Times
NOVEMBER 1, 2023
The AI tools to be deployed will help NHS staff to analyse X-rays and CT scans - News - PharmaTimes
Curavit launches HEOR services for digital therapeutic trials
Pharmaceutical Technology
NOVEMBER 1, 2023
Curavit will incorporate HEOR services into trials to elucidate the real-world financial impact of a new product.
UK government to open 160 community diagnostic centres a year early
Pharma Times
NOVEMBER 1, 2023
All CDCs will be open by March 2024 to speed up lifesaving checks and tests - News - PharmaTimes
Amgen scores FDA approval for Stelara biosimilar
Pharmaceutical Technology
NOVEMBER 1, 2023
The Amgen biosimilar Wezlana has been approved for all indications and is forecasted to yield $455m in 2029.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Rare disease clinical trials: The need for more patient- and site-centricity
Outsourcing Pharma
NOVEMBER 1, 2023
OSP had a quickfire interview with Rebecca Starkie, senior global patient engagement director, at Advanced Clinical where she explains the challenges faced by rare disease patients - and suggests ways to improve.
UK seizes illegal medicines and devices worth over £84m in last 15 years
Pharmaceutical Technology
NOVEMBER 1, 2023
As per WHO, about 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
Citius Oncology set to form following agreement between Citius Pharmaceuticals and TenX Keane
Outsourcing Pharma
NOVEMBER 1, 2023
A transaction between Citius Pharmaceuticals and TenX Keane which will result in the formation of Citius Oncology, Inc. is due to close in the first half of next year (2024).
After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara
Fierce Pharma
NOVEMBER 1, 2023
The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. | The FDA has approved Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But the new product will not launch until 2025 because of a settlement the companies made earlier this year, which delayed the launch in exchange for J&J dropping a patent infringement lawsuit.
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
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.
Element Biosciences to showcase its DNA sequencing platform 'disrupting the genomics industry'
Outsourcing Pharma
NOVEMBER 1, 2023
Element Biosciences, Inc., will share news of its sequencing methodology and host a workshop on higher accuracy sequencing for improved variant detection in Washington DC from today.
Novo Logs Over 700% Wegovy Sales Growth in Q3, Raises 2023 Outlook
BioSpace
NOVEMBER 1, 2023
Riding a wave of skyrocketing Wegovy and Ozempic sales, the company on Thursday raised its sales and operating profit outlook for the rest of the year as part of its third-quarter earnings announcement.
Merck's Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca's Imfinzi
Fierce Pharma
NOVEMBER 1, 2023
After AstraZeneca’s Imfinzi last year claimed new territory the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. | The approval was based off of Merck's phase 3 KEYNOTE-966 trial and marks Keytruda's sixth in gastrointestinal cancers. Meanwhile, AZ's Imfinzi scored its first approval in the space last year.
Novartis Adds Hidradenitis Suppurativa to Cosentyx’s Label in Challenge to Humira
BioSpace
NOVEMBER 1, 2023
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy
Fierce Pharma
NOVEMBER 1, 2023
After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. | BioMarin lured Genentech's CEO Alexander Hardy to take over upon Jean-Jacques Bienaimé's upcoming retirement after 18 years at the helm.
How Companies Use AI to Grade Candidates—and Even Potential Locations
BioSpace
NOVEMBER 1, 2023
The biopharma industry is moving toward using AI to try to determine how well a given person would perform in a role, with applications that go beyond recruiting.
Already nearing blockbuster status, GSK's RSV vaccine Arexvy outdueled Pfizer rival in first round of clash
Fierce Pharma
NOVEMBER 1, 2023
Besides Pfizer’s fast-declining COVID-19 sales, vaccine rival GSK is giving the New York drugmaker another reason to worry. | Aside from Pfizer's declining COVID-19 sales, GSK is giving the New York drugmaker another reason to worry. In the first round of their RSV vaccine showdown, GSK's Arexvy pulled down $860 million, more than doubling the haul from Pfizer's Abrysvo.
Lilly’s Mounjaro Beats Q3 Expectations, But Company Cuts Full-Year Profit Guidance
BioSpace
NOVEMBER 1, 2023
Sales of type 2 diabetes treatment Mounjaro brought in $1.4 billion in the third quarter. However, the company cut its full-year profit guidance due to charges mainly related to recent acquisitions.
Accelerating Clinical Supply Through Integrated Drug Development
Advertisement
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.
Let's personalize your content