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
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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.
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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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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.
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.
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AstraZeneca and Cellectis partner to advance cell and gene therapies
Pharmaceutical Technology
NOVEMBER 1, 2023
Cellectis will receive $25m in upfront payment, up to $220m in equity investment, and potential milestone based and royalty payments.
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.
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
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.
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
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.
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.
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.
The New Age of Decentralized Clinical Trials
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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
Bayer launches support tool for diabetic kidney disease
pharmaphorum
NOVEMBER 1, 2023
Bayer launches support tool for diabetic kidney disease Phil.
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.
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.
Argenx's Vyvgart gains commercial momentum in gMG as company plots expansion into new uses
Fierce Pharma
NOVEMBER 1, 2023
As Argenx works to grow the reach of its up-and-coming rare disease med Vyvgart, the company is seeing significant early gains for its lone commercial product. | Sales of Argenx’s Vyvgart increased by 151% to $329 million in the third quarter as the momentum for the treatment continues with its recent approval to be administered subcutaneously. The company also announced that it will use a priority review voucher to speed an FDA decision on an application for Vyvgart to treat a second immunoglob
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.
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.
Imfinzi faces Keytruda competition in biliary tract cancer
pharmaphorum
NOVEMBER 1, 2023
Imfinzi faces Keytruda competition in biliary tract cancer Phil.
The New Age of Decentralized Clinical Trials
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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.
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.
GSK licenses hepatitis B drug from J&J in $1bn deal
pharmaphorum
NOVEMBER 1, 2023
GSK licenses hepatitis B drug from J&J in $1bn deal Phil.
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.
The Crucial Role of MedDRA Integration in Pharmacovigilance
Cloudbyz
NOVEMBER 1, 2023
Pharmacovigilance is a critical aspect of the pharmaceutical industry, dedicated to ensuring the safety of drugs and medical products once they are in the market. Monitoring and assessing the safety of these products involves the collection, analysis, and reporting of adverse events and drug reactions. To accomplish this effectively and consistently, the integration of the MedDRA (Medical Dictionary for Regulatory Activities) is essential.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
12 Questions with Andrea Manfrin
pharmaphorum
NOVEMBER 1, 2023
12 Questions with Andrea Manfrin Mike.
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
X4 cues up FDA verdict in April for WHIM syndrome drug
pharmaphorum
NOVEMBER 1, 2023
X4 cues up FDA verdict in April for WHIM syndrome drug Phil.
FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma
Pharmaceutical Commerce
NOVEMBER 1, 2023
SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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