Bio Pharma Dive
JUNE 20, 2024
RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2024
(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.
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Bio Pharma Dive
JUNE 20, 2024
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2024
The drug control department in Tamil Nadu will soon introduce an action plan to contain antimicrobial resistance (AMR), and a stakeholders meeting is likely to be held very soon, It is learnt from reliable source that in the state action plan, the drug control department will have a significant role in implementing the programmes.
Bio Pharma Dive
JUNE 20, 2024
Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.
Pharmaceutical Technology
JUNE 20, 2024
iOnctura’s two lead cancer assets are a phosphoinositide 3-kinase delta modulator, roginolisib, and cambritaxestat, an autotaxin inhibitor.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 20, 2024
Tech such as eConsent can resolve the participant retention issue in clinical trials by removing inefficiencies and simplifying onboarding.
Bio Pharma Dive
JUNE 20, 2024
The decision makes Elevidys available to Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.
Pharmaceutical Technology
JUNE 20, 2024
Botanix Pharmaceuticals announced the receipt of FDA approval for Sofdra for excessive underarm sweating or primary axillary hyperhidrosis.
Rethinking Clinical Trials
JUNE 20, 2024
NIH Pragmatic Trials Collaboratory Health Equity Core cochairs Rosa Gonzalez Guarda and Cherise Harrington recently discussed the Core’s work supporting the NIH Collaboratory Trials to address issues related to health equity. Gonzalez-Guarda and Harrington sat down together during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May and reflected on the past year.
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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
JUNE 20, 2024
GC Cell has partnered with PT Bifarma Adiluhung to introduce Immuncell-LC for hepatocellular carcinoma to the Indonesian healthcare market.
Fierce Pharma
JUNE 20, 2024
For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.
Pharmaceutical Technology
JUNE 20, 2024
The China NMPA has approved Dizal’s golidocitinib for adults with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL).
Rethinking Clinical Trials
JUNE 20, 2024
NIH Pragmatic Trials Collaboratory Health Equity Core cochairs Rosa Gonzalez Guarda and Cherise Harrington recently discussed the Core’s work supporting the NIH Collaboratory Trials to address issues related to health equity. Gonzalez-Guarda and Harrington sat down together during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May and reflected on the past year.
Pharmaceutical Technology
JUNE 20, 2024
Researchers at the University of Birmingham have discovered a mechanism of enzyme communication that could aid drug development.
Fierce Pharma
JUNE 20, 2024
There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.
Pharmaceutical Technology
JUNE 20, 2024
Basilea sold and transferred the rights for its glioblastoma drug lisavanbulin, which has been studied in a Phase I/II study.
Fierce Pharma
JUNE 20, 2024
Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.
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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
JUNE 20, 2024
Following recommendations made by the Commission on Human Medicines, the UK MHRA has introduced new safety measures.
Fierce Pharma
JUNE 20, 2024
In May, Johnson & Johnson touted the success of its intraven | After touting the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease, Johnson & Johnson has shown the success of a subcutaneous (SC) version of Tremfya in another Crohn's disease study.
Drug Patent Watch
JUNE 20, 2024
In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry.
BioSpace
JUNE 20, 2024
While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
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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
JUNE 20, 2024
The progressive neurodegenerative condition affects more than ten million people worldwide
BioSpace
JUNE 20, 2024
The combined company began trading Friday under the Nasdaq symbol TECX. A $130 million private placement was also completed, with a cash runway into mid-2027.
pharmaphorum
JUNE 20, 2024
AbbVie’s Skyrizi is approved by the FDA for ulcerative colitis, making it the first IL-23 inhibitor indicated for both major types of inflammatory bowel disease.
BioSpace
JUNE 20, 2024
Jazz Pharmaceuticals’ calcium channel modulator suvecaltamide in a mid-stage trial was unable to significantly lower tremor burden in patients with essential tremor, the company reported Thursday.
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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.
pharmaphorum
JUNE 20, 2024
Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.
BioSpace
JUNE 20, 2024
Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.
Fierce Pharma
JUNE 20, 2024
After plugging nearly 50 million euros into its Italy operations in the first half of the decade, Johnson & Johnson Innovative Medicine is significantly upping its commitment to the country.
pharmaphorum
JUNE 20, 2024
Discover how AI-powered analytics are revolutionising life sciences marketing. Learn how to leverage these cutting-edge technologies to drive insights and success in the industry.
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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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