Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
Bio Pharma Dive
AUGUST 25, 2023
According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.
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Pharmaceutical Technology
AUGUST 25, 2023
Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.
Bio Pharma Dive
AUGUST 25, 2023
Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.
Pharmaceutical Technology
AUGUST 25, 2023
Patient data sharing among various stakeholders for research purposes forms the baseline for innovative new healthcare solutions pertinent to diagnosis, treatment, preventive measures, etc.
Bio Pharma Dive
AUGUST 25, 2023
After trial results showed the obesity drug can prevent heart attacks, the company now has data indicating it can help people with heart failure, too.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 25, 2023
Biotech's IPO drought has endured into late August, but a small group of drugmakers are now in line ahead of a fall that analysts predict could be busier.
Pharmaceutical Technology
AUGUST 25, 2023
Merck (MSD) and AstraZeneca have received approval in Japan for Lynparza to treat BRCA-mutated (BRCAm) castration-resistant prostate cancer.
Bio Pharma Dive
AUGUST 25, 2023
The company plans to enroll roughly 17,000 people in three Phase 3 trials of the drug, including a large cardiovascular study set to begin later this year.
Pharmaceutical Technology
AUGUST 25, 2023
Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported.
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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
Drug Discovery World
AUGUST 25, 2023
DDW’s Megan Thomas looks at a day in the life of Giusy Di Conza , Head of Research at iOnctura. MT: Where do you work, and can you tell us what you’re working on at the moment? GDC : I’m Head of Research for a young, dynamic biotech called iOnctura. We are pioneering research into new biological mechanisms for established drug targets. Whereas traditionally biotechs have studied the effect of a drug on a singular pathway, we are focused on targets that are involved in multiple independent tumour
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration (FDA) has granted clearance to Gilead Sciences’ supplemental new drug application (sNDA) for Veklury.
XTalks
AUGUST 25, 2023
In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens.
Pharmaceutical Technology
AUGUST 25, 2023
The EC has granted marketing authorisation for Pfizer’s bivalent RSV prefusion F vaccine, Abrysvo, for pregnant women and older adults.
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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
Intouch Solutions
AUGUST 25, 2023
“Aside from the smashing success of ‘Barbie’ setting box office records, topping more than [$1 billion] and counting, the movie is also doing something much more important than sales – shining a spotlight on women’s health. In a time where there seems to be a war waged on women’s reproductive health and autonomy, Barbie (of all symbols!
Pharmaceutical Technology
AUGUST 25, 2023
The Sandoz biosimilar, Tyruko, was approved by the US FDA for all labelled indications of Tysabri based on Phase I and III data.
Drug Discovery World
AUGUST 25, 2023
As negotiations continue between the UK and EU over Horizon Europe, the largest collaborative research programme in the world, the scientific research community has urged the Prime Minister to secure the UK’s membership as soon as possible. Figures reported in The Guardian from the European Commission emphasise the importance of the programme to UK research.
Pharmaceutical Technology
AUGUST 25, 2023
In light of the conviction of UK nurse Lucy Letby for murder, doctors are calling for a revisit of whistle-blowing policies.
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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
AUGUST 25, 2023
The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee - News - PharmaTimes
Pharmaceutical Technology
AUGUST 25, 2023
The latest fundraise will close in 2024, with plans for one Phase II trial to start by mid-2024.
Outsourcing Pharma
AUGUST 25, 2023
Emerald Cloud Lab (ECL) was the worldâs first highly automated cloud laboratory, was set up by two friends, Brian Frezza and D.J Kleinbaum who grew up together and joined forces after their PhDs to found the company.
Fierce Pharma
AUGUST 25, 2023
With one week to go until the Centers for Medicare and Medicaid Services (CMS) releases its list of ten drugs up for the first round of pricing negotiations, AstraZeneca is jumping into the legal b | The company cited concerns with the law's consequences for orphan drug development. AstraZeneca becomes the sixth drugmaker to file suit against the IRA.
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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.
Outsourcing Pharma
AUGUST 25, 2023
STARLIMS, a company that provides enterprise informatics solutions has acquired Labstep, a research and development (R&D) electronic laboratory notebook (ELN).
Fierce Pharma
AUGUST 25, 2023
Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. | Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. The companies have decided to shut down a phase 3 study testing the PD-1/TKI combo in first-line head and neck cancer.
Drug Channels
AUGUST 25, 2023
Today’s guest post comes from Chris Dowd, Senior Vice President of Market Development at ConnectiveRx. Chris discusses how such copay adjustment programs as accumulators and maximizers impact patients. He also discusses current legal cases that cover prescription medication access. To learn more, register for ConnectiveRx’s free October online panel discussion with Chris: The Battle Over Accumulators and Maximizers: What You Need to Know for 2024.
Fierce Pharma
AUGUST 25, 2023
Two months after a federal court in Delaware rejected Biogen’s patent infringement c | The FDA has endorsed Novartis' Tyruco as the first U.S. biosimilar to treat multiple sclerosis. The copycat will compete with Biogen's Tysabri, covering all of the original drug's indications for relapsing MS in addition to Crohn’s disease.
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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.
Pharma Times
AUGUST 25, 2023
The disease-modifying therapy is approved to treat all indications covered by Tysabri - News - PharmaTimes
Fierce Pharma
AUGUST 25, 2023
Every year, the teams at Fierce Pharma, Fierce Biotech and Fierce Medtech compile lists of the highest-paid executives in their respective fields, and every year, those lists remain woefully low on | Nominations are now open for this year’s list of the fiercest women in pharma, biotech and medtech.
BioPharma Reporter
AUGUST 25, 2023
Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.
Drug Patent Watch
AUGUST 25, 2023
Annual Drug Patent Expirations for ORLADEYO Orladeyo is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are seven patents protecting… The post New patent for Biocryst drug ORLADEYO 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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