Pharmaceutical Technology
MAY 28, 2024
Nearly 37% of subjects experienced serious treatment-emergent adverse events, with thrombocytopenia and interstitial lung disease (ILD) being notable events.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 28, 2024
There are a lot of connected, moving biological parts in our brains, which makes the study of brain diseases particularly challenging. Now new research has shed light on a key brain process potentially involved in Alzheimer’s disease.
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Pharmaceutical Technology
MAY 28, 2024
The US FDA has accepted for priority review Sanofi's sBLA for Sarclisa regimen for transplant-ineligible newly diagnosed multiple myeloma.
Bio Pharma Dive
MAY 28, 2024
The deal involves royalties for a brain cancer drug Agios previously sold off and that Royalty Pharma thinks could generate more than $1 billion in U.S. sales.
Pharmaceutical Technology
MAY 28, 2024
Scientists of QUT have secured A$4m ($2.65m) grant from the US DoD for developing new treatments for Parkinson's disease.
Bio Pharma Dive
MAY 28, 2024
After reporting positive clinical trial results for its drug brensocatib, Insmed plans to later this year file for U.S. approval in bronchiectasis that’s not associated with cystic fibrosis.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 28, 2024
The veteran executive will be replaced by Boris Zaïtra. Elsewhere, Nippon Shinyaku shared negative Phase 3 data and Merck unveiled new breast cancer results for Keytruda.
Rethinking Clinical Trials
MAY 28, 2024
Drs. Kevin Weinfurt, Lesley Curtis, and Adrian Hernandez, co–principal investigators of the Coordinating Center Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, on May 9 and 10 for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.
Bio Pharma Dive
MAY 28, 2024
Artificial intelligence (AI) has sparked a revolution in the pharmaceutical industry, reshaping the way we approach complex biological challenges.
Pharma Mirror
MAY 28, 2024
By Justin Kozak, Executive VP & Life Sciences Lead, Founder Shield The tide is turning in the once-booming biotech industry. Funding slowdowns and heightened competition are forcing companies to re-evaluate their strategies. Restructuring, including mergers and acquisitions (M&As) as well as workforce adjustments, has become a common theme. In this shifting environment, proactive risk management and strategic planning are crucial for biotech leaders.
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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
MAY 28, 2024
J&J has made its second dermatology deal this month, adding Numab’s bispecific antibody NM26 to its growing atopic dermatitis drug portfolio.
Bio Pharma Dive
MAY 28, 2024
The deal is J&J’s second this month involving bispecific antibodies, which the company has prioritized to build its immune and cancer drug pipeline.
Pharmaceutical Technology
MAY 28, 2024
A Phase III trial evaluating Rakuten’s photoimmunotherapy in combination with Keytruda in recurrent HNSCC is planned for H2 this year.
BioSpace
MAY 28, 2024
As AstraZeneca looks to climb toward the top of biopharma companies by revenue by the end of the decade, smaller companies are looking to join the ranks of the unofficial Big Pharma club.
Pharmaceutical Technology
MAY 28, 2024
Biomanufacturers using self-amplifying RNA, or saRNA, could enjoy significant advantages
Fierce Pharma
MAY 28, 2024
A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.
Pharmaceutical Technology
MAY 28, 2024
Currently in a Phase IIa study, AV-001 is being co-developed with AnGes for the prevention and treatment of ARDS in pneumonia.
BioSpace
MAY 28, 2024
Merck on Wednesday announced a deal worth $3 billion to buy EyeBio and its first-in-class trispecific antibody Restoret, marking the pharma’s return to the ophthalmology space after nearly a decade.
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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
MAY 28, 2024
Asahi Kasei has made a public cash offer for the acquisition of all shares in Calliditas for a total deal value of $1.04bn.
Fierce Pharma
MAY 28, 2024
A data breach at drug distributor Cencora has left sensitive information vulnerable, with patients on medicines from a dozen drugmakers potentially affected. | The potentially compromised data included patient information such as names and addresses, Cencora disclosed in letters to patients who may have been affected.
Pharmaceutical Technology
MAY 28, 2024
Investor optimism in biotech has increased due to the expected lowering of interest rates as inflation slows.
BioSpace
MAY 28, 2024
Driven by growing market demand and an improving supply chain, the global weight-loss drug market is expected to hit $150 billion in value by the early 2030s, according to analysts cited by Reuters.
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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
MAY 28, 2024
Helsinn Group has renewed an agreement with Angelini Pharma for the commercialisation of AULIN and MESULID.
BioSpace
MAY 28, 2024
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Pharmaceutical Technology
MAY 28, 2024
Logistics service providers (LSPs) can help pharma companies achieve their supply chain goals
XTalks
MAY 28, 2024
The traditional clinical trials model is facing scrutiny. Marked by high costs ranging from $1 billion to $2 billion, lengthy timelines extending five to ten years and success rates falling below ten percent, there is a pressing need for reform. These daunting figures highlight the necessity for innovative solutions that can accelerate the journey of new drugs from the lab to patients.
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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
MAY 28, 2024
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
pharmaphorum
MAY 28, 2024
The rise of AI is shaking up the healthcare industry. Learn how the MHRA is working to ensure the safe and effective use of AI in drugs and medical devices.
BioSpace
MAY 28, 2024
AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
Fierce Pharma
MAY 28, 2024
Bolstered by a full FDA approval for its primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo, Calliditas has earned the attention of Japanese chemical giant Asahi Kasei. | Asahi Kasei has made a cash offer to acquire Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), the companies announced Tuesday. Asahi’s bid represents a 74% premium to Calliditas' prior closing price.
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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.
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