Bio Pharma Dive
MARCH 8, 2024
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
Pharmaceutical Technology
MARCH 8, 2024
Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.
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Bio Pharma Dive
MARCH 8, 2024
The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.
Pharmaceutical Technology
MARCH 8, 2024
Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.
Bio Pharma Dive
MARCH 8, 2024
The approval makes Novo’s Wegovy the first weight-loss drug with such a claim on its prescribing information, which could have important implications for use and insurance coverage.
Pharmaceutical Technology
MARCH 8, 2024
The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 8, 2024
The US FDA has granted approval for BMS' Opdivo for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
Fierce Pharma
MARCH 8, 2024
Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.
Pharmaceutical Technology
MARCH 8, 2024
While some biotechs are attempting to develop disease-modifying therapies for amyotrophic lateral sclerosis (ALS), it has proven challenging.
pharmaphorum
MARCH 8, 2024
Celebrate International Women’s Day by learning about Miruna Sasu, a prominent female figure in the life sciences field and CEO of COTA. Explore how the company uses AI in the oncology space.
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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
MARCH 8, 2024
While Lilly’s Alzheimer’s drug was previously expected in Q1 2024, an FDA-mandated review at an unknown date means a decision may be delayed.
pharmaphorum
MARCH 8, 2024
Discover how a digital ecosystem can unite stakeholders in providing holistic maternity care, enhance maternal and postpartum care outcomes, and bridge the gap in healthcare services.
Pharmaceutical Technology
MARCH 8, 2024
CPI’s new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland could help overcome many challenges with sustainability.
Fierce Pharma
MARCH 8, 2024
As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.
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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
MARCH 8, 2024
The UK MHRA has approved Marinus Pharmaceuticals Emerald’s ganaxolone, an anti-seizure medication for CDKL5 deficiency disorder (CDD).
pharmaphorum
MARCH 8, 2024
Angie Franks is a prominent female figure in the life sciences industry and perfect to highlight on International Women's Day. Learn more about her contributions and achievements in healthcare and technology.
Pharmaceutical Technology
MARCH 8, 2024
The company revealed the data at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD) Conference 2024.
pharmaphorum
MARCH 8, 2024
Clinical research continues to struggle with a lack of representation within trial populations, and gender diversity in clinical trials remains a critical issue. Learn about the importance of gender diversity in clinical research trials and how it can accelerate inclusion in innovation.
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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
MARCH 8, 2024
Amylyx’s stocks plummeted by more than 85% after announcing it is considering scrapping the drug due to the trial failure.
pharmaphorum
MARCH 8, 2024
Amongst Novo Nordisk's comprehensive business update to investors, attention latched onto early data for an oral obesity therapy that outperformed the company’s big-selling GLP-1 agonist Wegovy in a clinical trial. The drug, called amycretin and codenamed NN9487, is a dual agonist that targets both GLP-1 and amylin and is being developed in both oral and subcutaneous injection formulations.
Pharmaceutical Technology
MARCH 8, 2024
SK bioscience has broken ground on a significant expansion of its vaccine manufacturing facility, L HOUSE, in South Korea.
Fierce Pharma
MARCH 8, 2024
After reporting the failu | After reporting the failure of a confirmatory trial of its amyotrophic lateral sclerosis drug Relyvrio (AMX0035), Amylyx Pharmaceuticals is uncertain whether it will pull the treatment from the market in the U.S. and in Canada, where it is known as Albrioza.
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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.
pharmaphorum
MARCH 8, 2024
In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.
Pharma Times
MARCH 8, 2024
The gamma treatment also shows potential for treating patients living with neurological diseases
pharmaphorum
MARCH 8, 2024
The UK government plans to link the NHS App to data generated by smart devices, including step counts and heart rate, according to Health Secretary Victoria Atkins.
Pharma Times
MARCH 8, 2024
The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK
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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 Channels
MARCH 8, 2024
Today’s guest post comes from Logan Melchione, VP of Patient Affordability at Paysign. Logan discusses the evolution of patient support programs. She then outlines how these programs must evolve to stay relevant and valuable. To request an analysis of your copay savings program and learn more about Paysign’s patient affordability solutions, contact affordability@paysign.com or visit paysign.com/rx.
Pharmaceutical Commerce
MARCH 8, 2024
A proposed Senate bill is intended to protect citizens’ private health and genetic information.
Fierce Pharma
MARCH 8, 2024
Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & | Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.
Drug Patent Watch
MARCH 8, 2024
Annual Drug Patent Expirations for ARNUITY+ELLIPTA Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Glaxosmithkline drug ARNUITY ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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