Bio Pharma Dive
JUNE 22, 2023
The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.
Pharmaceutical Technology
JUNE 22, 2023
Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children
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Bio Pharma Dive
JUNE 22, 2023
The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.
Pharmaceutical Technology
JUNE 22, 2023
The SFDA of the KSA has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular risk.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 22, 2023
Scientists have demonstrated how nasal drops containing a particular molecule can help mice recover from the damaging biological consequences of a stroke – and the hope is that the treatment could eventually be transferred to humans. [link] Crucially, the treatment isn’t applied straight away but is initiated seven days after the stroke.
Pharmaceutical Technology
JUNE 22, 2023
The recommendation comes after GSK published data showing its vaccine’s protection lasts over two RSV seasons.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 22, 2023
The company, which emerged from Paragon Therapeutics, is developing bowel disease drugs similar to Takeda's Entyvio and an experimental Prometheus drug just bought by Merck & Co.
Rethinking Clinical Trials
JUNE 22, 2023
Taunton Paine, Director of the NIH Scientific Data Sharing Policy Division At the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in May, we interviewed Taunton Paine, director of the NIH Scientific Data Sharing Policy Division, about the NIH’s new Data Management & Sharing Policy , which took effect in 2023. Under the new policy, all NIH-funded research requires a submission plan that describes how, where, and when data will be shared.
Bio Pharma Dive
JUNE 22, 2023
Some analysts see the new results as further confirmation that Roivant's medicine, which homes in on a popular drug target called TL1A, could become a blockbuster treatment for irritable bowel disease.
Pharmaceutical Technology
JUNE 22, 2023
Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide). The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g.
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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
Bio Pharma Dive
JUNE 22, 2023
The biotech is borrowing from Nobel Prize-winning “click chemistry” to develop medicines that can precisely target a variety of solid tumors.
Pharmaceutical Technology
JUNE 22, 2023
ADVANZ PHARMA has collaborated with Veeva Systems to set up a unified digital-first commercial foundation in Europe. ADVANZ intends to drive a unified field strategy across all markets and strengthen field engagement with healthcare professionals (HCPs) using Veeva Commercial Cloud, a family of data, software and services for advancing commercial excellence in life sciences.
Bio Pharma Dive
JUNE 22, 2023
The deal is the latest in a recent string of reverse mergers, which are enabling startups to sidestep initial public offerings in a difficult funding climate.
Pharmaceutical Technology
JUNE 22, 2023
After facing market challenges, the company sets its sights on an upcoming Phase III study that will enroll its first patient in H2 2023.
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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
JUNE 22, 2023
Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.
Pharmaceutical Technology
JUNE 22, 2023
MedTech companies are looking to expand their scope of influence with patients and providers by partnering with regulated companion apps.
Rethinking Clinical Trials
JUNE 22, 2023
Researchers from EMBED, an NIH Pragmatic Trials Collaboratory Demonstration Project, found a sharp rise in out-of-hospital overdose deaths in the early years of the COVID-19 pandemic, attributable largely to increasing involvement of fentanyl. The findings were published online ahead of print this week in the New England Journal of Medicine. EMBED was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States.
Pharmaceutical Technology
JUNE 22, 2023
Based on a trial spanning nearly a decade, the FDA has approved a supplemental biologics licence application for Blincyto.
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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.
Pharma Times
JUNE 22, 2023
ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes
Pharmaceutical Technology
JUNE 22, 2023
Earlier this month, plans were announced in the UK for a GLP-1RA pilot programme to take measures on obesity.
Fierce Pharma
JUNE 22, 2023
The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.
XTalks
JUNE 22, 2023
Ransomware attacks targeting the food industry have become increasingly prevalent and damaging over the past few years. Between 2018 and May 2023, there have been 157 confirmed ransomware attacks on the food, beverage and agriculture industries, with 2021 having the most attacks at 64. These attacks have cost the world economy $1.36 billion in downtime alone, and have resulted in the breach of 696,832 individual records.
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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.
Fierce Pharma
JUNE 22, 2023
The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 and older—in consultation with their doctors—receive vacc | The CDC's Advisory Committee on Immunization Practices has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus.
Pharma Times
JUNE 22, 2023
Poolbeg’s platform will possess the capability to generate vaccines for a wide range of diseases - News - PharmaTimes
BioPharma Reporter
JUNE 22, 2023
Amgen has announced that the US Food and Drug administration (FDA) has converted the accelerated approval for its blood cancer treatment Blincyto to a full approval.
BioSpace
JUNE 22, 2023
Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental 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.
Fierce Pharma
JUNE 22, 2023
In this episode of "The Top Line," we talk with Fierce’s Eric Sagonowsky and Kevin Dunleavy about the most expensive drugs in the U.S. | This week on "The Top Line," we discuss the most expensive drugs in the U.S., plus Eli Lilly's recent acquisition, the latest company to challenge the Inflation Reduction Act, and the rest of the week's headlines.
BioSpace
JUNE 22, 2023
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Fierce Pharma
JUNE 22, 2023
After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. | After the FDA said it needed "modest additional time" to review the therapy, the agency has ultimately approved the Duchenne muscular dystrophy gene therapy under the accelerated approval pathway.
BioSpace
JUNE 22, 2023
The FDA has again denied Intercept’s bid to have its obeticholic acid tablets approved in non-alcoholic steatohepatitis, forcing the company to abandon the indication and restructure operations.
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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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