Bio Pharma Dive
JULY 10, 2024
Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2024
A class of diabetes medications, which include the best-selling drug Ozempic, are associated with a reduced risk of certain obesity-related cancers, according to a study released Friday.
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Pharmaceutical Technology
JULY 10, 2024
Almirall’s Ebglyss is predicted to hit blockbuster status in two years in the crowded atopic dermatitis market.
Rethinking Clinical Trials
JULY 10, 2024
Dr. Miguel Hernán In this Friday’s PCT Grand Rounds, Miguel Hernán of Harvard University will present “Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them?” The Grand Rounds session will be held on Friday, July 12, 2024, at 1:00 pm eastern. Hernán is the Kolokotrones Professor of Biostatistics and Epidemiology and the director of the CAUSALab at Harvard T.H.
Pharmaceutical Technology
JULY 10, 2024
Evotec and Pfizer have entered a multi-year partnership that will focus initially on early discovery research.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 10, 2024
By focusing on clinical excellence, comprehensive education, and cutting-edge research, the Arya Vaidya Pharmacy Research Foundation (AVPRF) based in Coimbatore is ensuring that ayurvedic practices are validated, credible, and relevant for future generations. This holistic approach not only enhances the field of Ayurveda but also promises better health outcomes for patients worldwide, says Dr.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 10, 2024
IntegriChain, a provider of data-driven commercialisation solutions for the pharma industry, has acquired Federal Compliance Solutions (FCS).
Bio Pharma Dive
JULY 10, 2024
The latest round of funding comes as biotech company creator adds executives and prepares to grow more life sciences startups.
Pharmaceutical Technology
JULY 10, 2024
Lomecel-B is also being investigated for treating hypoplastic left heart syndrome, and ageing-related frailty, in addition to Alzheimer’s.
Bio Pharma Dive
JULY 10, 2024
With more Americans taking obesity medications, adjacent businesses are offering supportive services to offset side effects, collect data and document new health benefits.
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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
JULY 10, 2024
Pint Pharma has announced the approval of Orladeyo (berotralstat) in Peru to prevent hereditary angioedema (HAE) attacks.
Bio Pharma Dive
JULY 10, 2024
Roopal Thakkar will succeed Tom Hudson as AbbVie’s top scientist. Elsewhere, Skyhawk is advancing its Huntington’s drug and Zevra is preparing for an FDA advisory committee meeting.
Pharmaceutical Technology
JULY 10, 2024
The FDA has approved the once-daily topical cream for mild to moderate atopic dermatitis in patients aged six and older.
BioSpace
JULY 10, 2024
Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.
Pharmaceutical Technology
JULY 10, 2024
Vistagen has expanded its global intellectual property portfolio with the receipt of multiple new patents for its PH80 for migraine.
BioSpace
JULY 10, 2024
Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong, but details expected later this summer are critical.
Fierce Pharma
JULY 10, 2024
It’s well known that obesity drugs from Novo Nordisk and Eli Lilly are on a high-flying growth trajectory that doesn’t look to be letting up anytime soon. | Novo Nordisk's Ozempic is slated to take over No.1, while Merck's Keytruda falls to No.9 on Evaluate's predicted rankings of top drugs by 2030 sales.
BioSpace
JULY 10, 2024
Biotech venture capital firm Flagship Pioneering is looking to fund companies focused on artificial intelligence, human health and sustainability, bringing the total raised since 2021 to $6.4 billion.
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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
JULY 10, 2024
Learn how to successfully transition pilots into production with GenAI in the pharmaceutical industry. Discover strategies to create, scale, and achieve success with this innovative technology.
BioSpace
JULY 10, 2024
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
pharmaphorum
JULY 10, 2024
After short but worrying delay, Arcutis gets FDA approval for flagship drug Zoryve in atopic dermatitis, which could further unlock sales growth
BioSpace
JULY 10, 2024
The regulator Tuesday added atopic dermatitis to the label of Arcutis Biotherapeutics’ topical PDE4 inhibitor Zoryve for the treatment of patients six years of age and older.
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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
Fierce Pharma
JULY 10, 2024
While much of the attention on Novo Nordisk these days revolves around the company’s wildly popular GLP-1 drugs Ozempic and Wegovy, insulin remains a critical backbone for the drugmaker. | As Novo Nordisk steadily ups its commitments in Asia, the company is teaming up with Indonesia’s state-owned pharmaceutical firm Bio Farma to bolster insulin packaging in the southeast Asian nation.
BioSpace
JULY 10, 2024
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
Pharmaceutical Commerce
JULY 10, 2024
In an interview with Pharma Commerce editor Nicholas Saraceno, Peter Ax, UpScriptHealth, founder and CEO, offers his thoughts surrounding the lack of supply.
BioSpace
JULY 10, 2024
After pulling its ALS drug Relyvrio from the market, Amylyx Pharmaceuticals has purchased Eiger BioPharmaceuticals’ GLP-1 avexitide, which has been studied for the treatment of hyperinsulinemic hypoglycemia.
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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
JULY 10, 2024
Shares in Dutch biotech uniQure shoot up after Huntington’s candidate AMT-130 slows disease progression by 80% two years after dosing.
Fierce Pharma
JULY 10, 2024
Editor's note: This story was corrected to note that Brooks will be Eli Lilly's interim CFO. | Gordon Brooks, currently Eli Lilly's group vice president, controller and corporate strategy, will take the interim role after 29 years at the drugmaker.
BioSpace
JULY 10, 2024
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
Drug Patent Watch
JULY 10, 2024
This is an example from the DrugPatentWatch AI Research Assistant, which is available with DrugPatentWatch subscriptions.
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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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