Bio Pharma Dive
AUGUST 28, 2023
Urged by a judge, the antitrust regulator said it wants to start discussions “regarding the proper resolution of this matter” — a potential prelude to a settlement.
Pharmaceutical Technology
AUGUST 28, 2023
Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.
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Bio Pharma Dive
AUGUST 28, 2023
GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 28, 2023
Rich in fruits, vegetables, whole grains, and fish, the Mediterranean diet has long been linked with improving health. In fact, living a Mediterranean lifestyle in general could be the ticket to a longer, healthier life.
Bio Pharma Dive
AUGUST 28, 2023
With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 28, 2023
India’s success story in pediatric vaccination programme should be further replicated in the form of adult vaccination programme, experts recommended on the occasion of the 2nd edition of the India Vaccine Leaders Conclave (IVLC) held between August 22 and August 23, 2023 under the theme “Building Resilient Vaccine Ecosystems” in Mumbai.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 28, 2023
GC Biopharma has signed a memorandum of understanding (MOU) with Eubiologics to jointly manufacture oral cholera vaccine, Euvichol.
Bio Pharma Dive
AUGUST 28, 2023
The acquisition gives Danaher ownership of a producer of research tools, such as antibodies and reagents, that are used in drug discovery experiments.
Pharmaceutical Technology
AUGUST 28, 2023
Pharmaceutical firm Phebra has reached a new six-year collaboration agreement with Australia’s University of Wollongong (UOW)
Bio Pharma Dive
AUGUST 28, 2023
Is pharma up to the challenge of delivering the personalized and contextual experiences doctors have come to expect? Too often, the answer is no.
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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
AUGUST 28, 2023
Novartis division Sandoz has concluded the acquisition of global brand rights for the antifungal agent Mycamine from Astellas.
Rethinking Clinical Trials
AUGUST 28, 2023
Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization.
Pharmaceutical Technology
AUGUST 28, 2023
The Janssen has submitted a sBLA to the US FDA for RYBREVANT plus chemotherapy for non-small cell lung cancer (NSCLC).
Rethinking Clinical Trials
AUGUST 28, 2023
Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization.
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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
AUGUST 28, 2023
It’s a sale. Two months after Abcam launched a strategic review of the company, the British antibody research expert has revealed that it’s being bought by Danaher. | Danaher Corporation is picking up all outstanding shares of Abcam for $24 apiece. Both companies’ boards unanimously approved the decision, Danaher and Abcam said Monday. The deal is expected to close in mid-2024.
Rethinking Clinical Trials
AUGUST 28, 2023
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Drug Patent Watch
AUGUST 28, 2023
In a guest column Kevin Wall, principal consultant and owner of Cincero Consulting, emphasizes the critical importance of selecting the right Contract Development and Manufacturing Organization (CDMO) for drug product… The post Key Factors for Choosing the Right CDMO appeared first on DrugPatentWatch - Make Better Decisions.
Outsourcing Pharma
AUGUST 28, 2023
With more than 63 biopharma companies attending and 15 event partners sharing solutions, the 7th annual IPF Summit being held in Boston next month (September 2023) is not to be missed.
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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.
Fierce Pharma
AUGUST 28, 2023
With seven posters and nine presentations on Farxiga over the weekend at the European Society of Cardiology (ESC) scientific sessions in Amsterdam, AstraZeneca made it clear that it has lots to say | As AstraZeneca's Farxiga has added four indications over the last five years—on top of its initial 2014 approval for Type 2 diabetes—its spillover benefits have become apparent and yielded a better understanding of the interconnections between Type 2 diabetes, heart failure and chronic kidney d
Outsourcing Pharma
AUGUST 28, 2023
CDMO, Sirio Europe, is launching two new softgels aimed at those who want to develop in the pharmaceutical consumer health space at this yearâs CPHI in Barcelona.
BioSpace
AUGUST 28, 2023
Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.
Fierce Pharma
AUGUST 28, 2023
Echoing an earlier move in the United Arab Emirates, CDMO National Resilience is again growing its presence in the Middle East. | CDMO National Resilience the latest drugmaker to set down roots in Saudi Arabia, following in the footsteps of Sanofi and Merck KGaA.
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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.
BioSpace
AUGUST 28, 2023
Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.
Fierce Pharma
AUGUST 28, 2023
After filing a closely watched lawsuit to block Amgen's proposed takeover of Horizon Therapeutics, the Federal Trade Commission (FTC) is pausing those efforts to consider whether it should settle t | The Federal Trade Commission has paused its challenge of the $27.8 billion merger between Amgen and Horizon Therapeutics to rethink whether it should settle the case.
BioSpace
AUGUST 28, 2023
The company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.
Fierce Pharma
AUGUST 28, 2023
It’s been well documented how Novo Nordisk has had difficulty in meeting the soaring demand for its GLP-1 weight loss treatments. | Amid supply problems, Novo Nordisk plans to launch its GLP--1 drugs in “more and more” countries, CEO Lars Fruergaard Jørgensen said at a recent Reuters event, though he added that the launches will be "constrained.
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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 Patent Watch
AUGUST 28, 2023
Annual Drug Patent Expirations for CAMCEVI+KIT Camcevi Kit is a drug marketed by Accord and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Accord drug CAMCEVI KIT appeared first on DrugPatentWatch - Make Better Decisions.
Fierce Pharma
AUGUST 28, 2023
As Alnylam persists in its COVID-19 patent litigation, the RNAi specialist has been dealt a blow in one of its lawsuits against Moderna. | As Alnylam persists in its COVID-19 patent litigation, the RNAi specialist has been dealt a blow in one of its lawsuits against Moderna. But Alnylam says it'll appeal the recent ruling.
Drug Patent Watch
AUGUST 28, 2023
Annual Drug Patent Expirations for GAVRETO Gavreto is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two patents… The post New patent for Genentech Inc drug GAVRETO appeared first on DrugPatentWatch - Make Better Decisions.
Fierce Pharma
AUGUST 28, 2023
With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health o | With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals are likely eager for the massive injectables facility to restart production.
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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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