Pharmaceutical Technology
AUGUST 22, 2024
Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.
Bio Pharma Dive
AUGUST 22, 2024
The approval of both reformulated messenger RNA vaccines, which are designed to target the KP.2 virus strain, comes just ahead of the fall and winter seasons.
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AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2024
The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.
Bio Pharma Dive
AUGUST 22, 2024
Borealis Biosciences launches with money from Novartis, which last year bought the biotech’s predecessor for a pair of drugs that treat a rare kidney disorder.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2024
Neurons aren’t the only brain cells producing the proteins associated with Alzheimer’s disease, a new study of mouse models reveals. It turns out that cells supporting neurons contribute to this process too. Amyloid beta proteins occur naturally in our brains, but have long, and now controversially, been associated with Alzheimer’s disease.
Bio Pharma Dive
AUGUST 22, 2024
The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 22, 2024
Leqembi’s benefits are “too small to justify the significant cost to the NHS,” said the head of a UK agency in charge of determining medicine reimbursement.
Pharmaceutical Technology
AUGUST 22, 2024
China's National Medical Products Administration (NMPA) has granted approval for Innovent Biologics’ Kristen rat sarcoma (KRAS) G12C inhibitor, Dupert (fulzerasib), to treat advanced non-small cell lung cancer (NSCLC) in adults.
Fierce Pharma
AUGUST 22, 2024
Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts. | Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts, the company said.
Pharmaceutical Technology
AUGUST 22, 2024
Discover Heidelberg Pharma AG's innovative patent enhancing CAR T-cell therapy for cancer and autoimmune diseases using anti-CD5 antibody drug conjugates for better outcomes.
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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 Commerce
AUGUST 22, 2024
In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.
Pharmaceutical Technology
AUGUST 22, 2024
Discover Larimar Therapeutics' groundbreaking patent on measuring frataxin (FXN) protein activity. Learn how this innovative method could impact research and therapies.
BioPharma Reporter
AUGUST 22, 2024
ImmPACT Bio has received FDA clearance to start clinical trials for its CD19/CD20 bispecific CAR-T cell therapy in multiple sclerosis (MS) patients.
Pharmaceutical Technology
AUGUST 22, 2024
Discover how Syndax Pharmaceuticals' new patent enhances cancer treatment by selecting patients for combination therapy using immune cell markers in blood samples.
XTalks
AUGUST 22, 2024
After a nearly two-year-long shortage, the US Food and Drug Administration (FDA) announced earlier this month that Eli Lilly’s GLP-1 diabetes drug Mounjaro (tirzepatide) is back on shelves along with weight loss version Zepbound. A few days later, GLP-1 drug rival Novo Nordisk announced that four out of five dose strengths of its GLP-1 obesity drug Wegovy (0.5 mg, 1 mg, 1.7 mg and 2.4 mg) are now available in the US.
Pharmaceutical Technology
AUGUST 22, 2024
Discover Avadel Pharmaceuticals' new patent for GHB formulations, enhancing narcolepsy treatment with a tailored dosage regimen for effective symptom relief.
Fierce Pharma
AUGUST 22, 2024
The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.
Pharmaceutical Technology
AUGUST 22, 2024
Discover CSPC Pharmaceutical's groundbreaking patent for compound III, an LSD1 inhibitor, with a novel crystal form aimed at treating small cell lung cancer.
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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.
pharmaphorum
AUGUST 22, 2024
BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.
Pharmaceutical Technology
AUGUST 22, 2024
Discover Antisense Therapeutics' groundbreaking patent for treating muscular dystrophy, enhancing muscle function with a unique oligonucleotide method.
BioPharma Reporter
AUGUST 22, 2024
Eisai and Biogenâs new Alzheimerâs treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimerâs disease.
Pharmaceutical Technology
AUGUST 22, 2024
A US FDA advisory committee (AdComm) is set to evaluate Zynquista as an adjunct therapy for type 1 diabetes and chronic kidney disease (CKD).
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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
Intouch Solutions
AUGUST 22, 2024
Digital accessibility is essential to your brand because it ensures that everyone, no matter their ability or use of assistive technology, can access and use your digital properties. Creating accessible digital properties (websites, apps, emails, banners, PDFs, videos, etc.) should be top of mind for pharmaceutical companies that want to stay competitive and legally compliant.
Pharmaceutical Technology
AUGUST 22, 2024
CTI Clinical Trial & Consulting Services and Crown Bioscience have announced a strategic partnership to boost oncology drug development.
Outsourcing Pharma
AUGUST 22, 2024
H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.
Pharmaceutical Technology
AUGUST 22, 2024
The FDA) has accepted the sBLA filed by BMS for Opdivo (nivolumab) and Yervoy (ipilimumab) to treat unresectable hepatocellular carcinoma.
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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.
BioPharma Reporter
AUGUST 22, 2024
The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.
Pharmaceutical Technology
AUGUST 22, 2024
Touchlight collaborated with the University of Nottingham to supply GMP-grade dbDNA tech to develop next-gen vaccine for the Zika virus.
Pharma Times
AUGUST 22, 2024
The grant will support clinical trials of rare disease therapy for leukodystrophy
Pharmaceutical Technology
AUGUST 22, 2024
Despite its marketing approval, Leqembi’s cost effectiveness falls short of NICE’s standards to justify wide range use in the UK.
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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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