Bio Pharma Dive
JUNE 30, 2023
The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.
Pharmaceutical Technology
JUNE 30, 2023
Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
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Bio Pharma Dive
JUNE 30, 2023
The life sciences investor spoke with BioPharma Dive about emerging life sciences markets around the globe and why the firm invests in first-time biotech founders.
Pharmaceutical Technology
JUNE 30, 2023
BioMed X has announced that it has begun a joint research project with Sanofi on artificial intelligence (AI) driven drug development.
Bio Pharma Dive
JUNE 30, 2023
An agreement to divest the dry eye disease treatment Xiidra and a few other medicines adds to the Swiss pharma's yearslong push to slim down from the healthcare conglomerate it once was.
Pharmaceutical Technology
JUNE 30, 2023
BioMarin’s Roctavian, a one-time therapy for severe haemophilia A, has secured FDA approval following previous rejections and delays.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 30, 2023
At DDW 2023, a comment was made following a presentation discussing the preliminary induction findings from the Phase IIb/III QUASAR (NCT04033445) trial in ulcerative colitis (UC).
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Incorrect billing can result in federal and state violations as well as financial penalties. “To ensure billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better,” said Kelly Willenber
Pharmaceutical Technology
JUNE 30, 2023
Cold agglutinin diseaseis under clinical development by NovelMed Therapeutics and currently in Phase I for Acquired (Autoimmune) Hemolytic Anemia.
Pharma Times
JUNE 30, 2023
ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes
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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
JUNE 30, 2023
Sangamo Therapeutics has signed a licence agreement with Voyager Therapeutics for a therapy to treat prion disease.
XTalks
JUNE 30, 2023
It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The US Food and Drug Administration (FDA) approved BioMarin’s Roctavian, an adeno-associated virus (AAV) vector-based gene therapy, for the treatment of adults with severe hemophilia A.
Pharmaceutical Technology
JUNE 30, 2023
Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of Sigilon Therapeutics for $309.6m.
Antidote
JUNE 30, 2023
Celiac disease is a common autoimmune disorder that causes a reaction to gluten within the small intestine. It is often underdiagnosed, but it is estimated to impact around 2 million people in the United States.
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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
JUNE 30, 2023
The EC has granted approval to BMS for Opdivo plus platinum-based chemotherapy to treat resectable non-small cell lung cancer patients.
XTalks
JUNE 30, 2023
Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM). This approval distinguishes Ultravist as the singular contrast agent in the US specifically indicated for visualizing confirmed or suspected breast lesions in adults in conjunction with mammography and/or ultrasound.
Pharmaceutical Technology
JUNE 30, 2023
Novartis has entered an agreement to divest its ophthalmology assets to eye health firm Bausch + Lomb in a deal valued at $2.5bn.
Intouch Solutions
JUNE 30, 2023
We told you it would be coming — and now, Apple’s Vision Pro VR/AR headset is finally here. Well, technically you can’t buy one until next year. But the device’s June unveiling did take over the Internet; people have watched the reveal video more than 50 million times. We also noticed Apple chief Tim Cook resisted the word “metaverse,” choosing instead to coin his own category for the splashy device: “spatial computing.
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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
JUNE 30, 2023
The European Commission has issued orphan drug designation (ODD) for Genenta Science’s Temferon to treat glioma.
Drug Patent Watch
JUNE 30, 2023
Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five patents… The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JUNE 30, 2023
Ustekinumab Biosimilar is a monoclonal antibody commercialized by Teva Pharmaceutical Industries, with a leading Pre-Registration program in Plaque Psoriasis (Psoriasis Vulgaris).
XTalks
JUNE 30, 2023
As consumer tastes and preferences continue to evolve, innovative food companies have risen to the occasion, captivating the market with their exceptional products and compelling narratives. In this blog, we will explore the dynamic landscape of the food industry and uncover the top five fastest growing food companies in 2023. The following list comprises the top-ranking food companies based on the Financial Times’ assessment of The Americas’ Fastest-Growing Companies in 2023.
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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.
Pharmaceutical Technology
JUNE 30, 2023
The offering comes hot on the heels of positive results from the company’s lung cancer candidate.
pharmaphorum
JUNE 30, 2023
Editor in Chief Jonah Comstock speaks with Mark Reisenauer, president, US Commercial at Astellas. Mark gives an update on some of Astellas’s abstracts at the show, including the trials in gastric cancer, bladder cancer, and head and neck cancer.
Pharmaceutical Technology
JUNE 30, 2023
Immune Thrombocytopeniais under clinical development by NovelMed Therapeutics and currently in Phase I for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura).
Fierce Pharma
JUNE 30, 2023
The Securities and Exchange Commission (SEC) has revealed insider trading charges against five—including former Alexion Vice President | The SEC has revealed insider trading charges against five—including former Alexion vice president Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals.
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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.
Pharmaceutical Technology
JUNE 30, 2023
Vepdegestrant is a small molecule commercialized by Arvinas, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).
Pharma Times
JUNE 30, 2023
Partnership will establish drug candidates using both laboratory tests and machine-learning - News - PharmaTimes
Pharmaceutical Technology
JUNE 30, 2023
[177Lu]Lu-rhPSMA-10.1is under clinical development by Blue Earth Therapeutics and currently in Phase II for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Fierce Pharma
JUNE 30, 2023
Shareholders in Alkermes have quelled Sarissa Capital, reelecting seven board members and rejecting three nominees from the activist investor.
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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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