Bio Pharma Dive
APRIL 3, 2024
The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.
Worldwide Clinical Trials
APRIL 3, 2024
By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Rethinking Clinical Trials
APRIL 3, 2024
Dr. Erik van Zwet In this Friday’s PCT Grand Rounds, Erik van Zwet of Leiden University Medical Center will present “A New Look at P Values for Randomized Clinical Trials.” The Grand Rounds session will be held on Friday, April 5, 2024, at 1:00 pm eastern. Dr. van Zwet is an associate professor in the Department of Biomedical Data Sciences at Leiden University Medical Center in the Netherlands.
Bio Pharma Dive
APRIL 3, 2024
The buyout continues a surge in M&A for developers of antibody-drug conjugates and gives Genmab a potential competitor to a medicine AbbVie recently purchased in a multibillion-dollar acquisition.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 3, 2024
Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.
Bio Pharma Dive
APRIL 3, 2024
Oruka Therapeutics is the third startup from Paragon to go public since last year, and the second to do so by combining with another biotech.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
APRIL 3, 2024
This episode features an interview with Bruce Culleton, MD, CEO, ProKidney , a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease. Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare.
BioPharma Reporter
APRIL 3, 2024
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess the quality of clinical trial data.
Pharma Times
APRIL 3, 2024
The third most common and serious form of cancer affects over 43,000 people every year in the UK
XTalks
APRIL 3, 2024
The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH). PNH is characterized by the destruction of red blood cells (RBCs) within blood vessels (known as intravascular hemolysis, or IVH) and white blood cell (WB
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
APRIL 3, 2024
Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. | Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.
BioSpace
APRIL 3, 2024
Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.
Fierce Pharma
APRIL 3, 2024
Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping b | Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping block.
BioSpace
APRIL 3, 2024
Following disappointing late-stage data, Amylyx on Thursday said it is withdrawing the company’s amyotrophic lateral sclerosis drug Relyvrio from the U.S. and Canadian markets and cutting its workforce by approximately 70%.
Advertisement
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
Outsourcing Pharma
APRIL 3, 2024
Precision oncology innovator SimBioSys and General Inception have joined forces in a strategic partnership aimed at revolutionizing cancer drug development.
BioSpace
APRIL 3, 2024
A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.
Pharma Times
APRIL 3, 2024
The progressive neurodegenerative disease is estimated to affect 24 million people globally
BioSpace
APRIL 3, 2024
Three Biopharma firms disclosed concerns about how emerging geopolitical tensions between the U.S. and China might impact their business with the contract manufacturer.
Advertisement
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
APRIL 3, 2024
This critical year for drug discount management includes changes to the 340B programme, implications for Medicare, and updates on the Inflation Reduction Act.
BioSpace
APRIL 3, 2024
Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Fierce Pharma
APRIL 3, 2024
Medicare drug price negotiations under the Inflation Reduction Act are steadily progressing after drugmakers recently submitted their counteroffers to the government's initial pricing proposals.
BioSpace
APRIL 3, 2024
The American Association for Cancer Research has invited drug developers and investors to intermingle with the academics who typically attend its annual conference.
Advertisement
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
APRIL 3, 2024
Basilea Pharmaceutica gets US approval for its ceftobiprole antibiotic, around 15 years after the drug was first turned down by the FDA.
BioSpace
APRIL 3, 2024
There are several ways you can maintain a good working relationship with your boss, starting with learning your manager’s work style, preferences and priorities.
Intouch Solutions
APRIL 3, 2024
When we hear the topic “Modular Content and MLR Relationship,” we think and hear of the challenges with medical, legal and regulatory (MLR). Marketers are under immense pressure because omnichannel puts more demands on marketing to produce more content. But what’s really exciting is that AI is going to create the efficiencies that finally enable us to pull through that content.
Pharmaceutical Commerce
APRIL 3, 2024
An exploration of the new demands in cold-chain visibility and sustainability—and the resulting tech-driven efforts to address them—leads off our coverage in this month's issue.
Advertisement
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
APRIL 3, 2024
Discover how James Choi, of Samsung Biologics, is setting the standard for sustainability in the pharmaceutical industry. Learn about the company's initiatives and commitment to environmental responsibility.
Drug Channels
APRIL 3, 2024
This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars.
BioPharma Reporter
APRIL 3, 2024
Cartherics has entered a collaborative research agreement with TiCARos, to assess the company's proprietary CLIP-CAR technology in its induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells.
Drug Patent Watch
APRIL 3, 2024
EXSERVAN (riluzole) Aquestive Patent: 8,603,514 Expiration: Apr 3, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.
Advertisement
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.
Expert insights. Personalized for you.
280 
Let's personalize your content