Pharmaceutical Technology
OCTOBER 15, 2024
Pharmaceutical giants cannot work in a silo to reach net zero. Pharma contract manufactures have a duty to engage with the science-based climate targets, says ACG.
Rethinking Clinical Trials
OCTOBER 15, 2024
A new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials. Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size.
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Pharmaceutical Technology
OCTOBER 15, 2024
Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2024
(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.
Pharmaceutical Technology
OCTOBER 15, 2024
Lundbeck is to acquire Longboard for $2.6bn equity value in a move set to enhance its capabilities within neuro-rare conditions.
Bio Pharma Dive
OCTOBER 15, 2024
The pharma will work with Triana Biomedicines on molecular glue degraders. Elsewhere, Akeso raised $250 million and a MASH drug developer got a well-known board chair.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
OCTOBER 15, 2024
The amount surpassed the firm’s targets, allowing it to increase the size and number of company financings it plans to do in the future.
Pharmaceutical Technology
OCTOBER 15, 2024
Stelara is one of the most successful Crohn’s therapies, generating $10.8bn last year, Lilly hopes to introduce Omvoh as its competitor.
Bio Pharma Dive
OCTOBER 15, 2024
Biosimilar competition is expected in early January for the company’s second highest-selling drug, putting greater focus on newer products' market trajectory.
Pharmaceutical Technology
OCTOBER 15, 2024
digital twins can be used to progress healthcare, drug development, and research by enabling the delivery of personalised medicine.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 15, 2024
The Directorate General of Foreign Trade (DGFT) has issued Trade Notice No. 19/2024-25, dated October 4, 2024, to provide clarity regarding the Registration-Cum-Membership Certificate (RCMC) requirement for exporters under the Foreign Trade Policy (FTP) 2023.
Pharmaceutical Technology
OCTOBER 15, 2024
Bayer notches up pressure on rival Astellas’ Veozah with an EU marketing authorisation application for its hot flash relief pill.
Fierce Pharma
OCTOBER 15, 2024
Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.
Pharmaceutical Technology
OCTOBER 15, 2024
Despite this setback, Transgene plans to explore the potential benefits of the vaccine in specific patient populations.
pharmaphorum
OCTOBER 15, 2024
Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.
Pharmaceutical Technology
OCTOBER 15, 2024
The agreement will see MEDiC’s MCAT platform identify biomarkers to support the development of Hanmi’s clinical assets.
Fierce Pharma
OCTOBER 15, 2024
Jazz Pharmaceuticals’ Zepzelca, once on the brink of a market withdrawal, has returned with new trial results showing it could prolong patients’ lives in extensive-stage small cell lung cancer (ES- | Jazz Pharmaceuticals’ Zepzelca, once on the brink of a market withdrawal, has returned with new trial results showing it could prolong patients’ lives in extensive-stage small cell lung cancer.
Pharmaceutical Technology
OCTOBER 15, 2024
In pharmaceutical manufacturing, viscous drug products pose unique challenges to filling efficiency and accuracy.
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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
OCTOBER 15, 2024
GSK has filed lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and RSV
Pharmaceutical Technology
OCTOBER 15, 2024
Almirall has completed the decentralised regulatory procedure in Europe for efinaconazole to treat onychomycosis.
Drug Channels
OCTOBER 15, 2024
A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs). As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx. However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money.
Pharmaceutical Technology
OCTOBER 15, 2024
Boehringer Ingelheim, in partnership with the WHO Foundation, has committed $5m to enhance healthcare access.
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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
Pharma Times
OCTOBER 15, 2024
Study reveals potential new strategy for managing inflammatory bowel disease
pharmaphorum
OCTOBER 15, 2024
Health plans, employers, and healthcare providers plan to increase their spending on digital health technologies in the next 12 months, says PHTI survey
XTalks
OCTOBER 15, 2024
Seven cases of blood cancer have been identified in new trial data for bluebird bio’s gene therapy Skysona (elivaldogene autotemcel). The findings from a study published in The New England Journal of Medicine on October 9 reveal that seven out of 67 patients under the age of 18 who participated in Phase II and Phase III trials for Skysona (ALD-102 and ALD-104) developed hematologic cancers.
pharmaphorum
OCTOBER 15, 2024
mRNA vaccines, pivotal in the fight against COVID-19, are now emerging as a promising innovation in cancer treatment.
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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.
Drug Patent Watch
OCTOBER 15, 2024
Have you ever found yourself scratching your head at the pharmacy counter, wondering why your “3-month supply” of medication doesn’t quite match up with the calendar? You’re not alone. Many people are puzzled by the discrepancy between a 92-day supply of pills and the actual number of days in a three-month period.
pharmaphorum
OCTOBER 15, 2024
Transgene's therapeutic vaccine for cervical and anogenital cancers failed a phase 2 trial, but an efficacy signal warrants further study
Outsourcing Pharma
OCTOBER 15, 2024
The big pharma company Sanofi has discontinued a phase 2 trial of U.S. partner Denali Therapeuticsâ oditrasertib for the treatment of multiple sclerosis after the drug failed to perform.
pharmaphorum
OCTOBER 15, 2024
Germany is the first market for LEO Pharma's Anzupgo, the first topical treatment specifically approved for chronic hand eczema
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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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