Bio Pharma Dive
SEPTEMBER 11, 2023
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
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Bio Pharma Dive
SEPTEMBER 11, 2023
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.
Bio Pharma Dive
SEPTEMBER 11, 2023
The decision follows a review by a trial monitoring committee, which concluded data for the geographic atrophy treatment didn't support further development.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Coherus BioSciences has concluded the acquisition of immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Alexion has entered into a partnership with Verge Genomics to detect new drug targets for rare neurodegenerative and neuromuscular ailments.
Bio Pharma Dive
SEPTEMBER 11, 2023
Ultrasensitive technologies help researchers harness the potential of circulating tumor DNA analysis.
Pharmaceutical Technology
SEPTEMBER 11, 2023
The agency has set a PDUFA target action date to June 2024, with no current plans for an advisory meeting in the works.
Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
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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
SEPTEMBER 11, 2023
Mark Chadwick explains how CSRD, the EU's new ESg reporting regulation, will impact pharmaceutical companies.
Rethinking Clinical Trials
SEPTEMBER 11, 2023
On January 24-25, 2024, the IMPACT Collaboratory will hold its fourth annual virtual Training Workshop entitled Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners. The 1.5-day virtual workshop features all new material to build a foundation in practical aspects of designing and conducting embedded pragmatic trials in Alzheimer disease and related dementias.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Grit Biotechnology has secured more than $60m in a Series B funding round to support the development of its pipeline programmes.
Pharma Times
SEPTEMBER 11, 2023
Both companies will work to advance the development of novel radiopharmaceuticals - News - PharmaTimes
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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
SEPTEMBER 11, 2023
Viedoc is a Category Award Winner for Innovation and Product Launches in the 2023 Pharmaceutical Technology Excellence Awards
XTalks
SEPTEMBER 11, 2023
The Centers for Medicare & Medicaid Services (CMS) announced the first ten drugs that will be entering Medicare drug price negotiations. The drugs are covered under Part D of the Medicare program, which provides coverage for prescription drugs. Individuals insured under Medicare mainly include seniors 65 years of age and older. The drugs were selected by the US Department of Health and Human Services (HHS) as part of US President Joe Biden’s Inflation Reduction Act (IRA), a historic law pass
Pharmaceutical Technology
SEPTEMBER 11, 2023
With many biopharma companies outsourcing for manufacturing support, how can your organisation outpace the competition?
BioSpace
SEPTEMBER 11, 2023
With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.
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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
SEPTEMBER 11, 2023
The US FDA has awarded Biosyngen’s IND for the T-cell receptor therapy, BRL03, to start Phase I/II trials in lung and other solid cancers.
BioPharma Reporter
SEPTEMBER 11, 2023
Chiesi, the biopharmaceutical and healthcare group, has announced that the National Institute for Health and Care Excellence (NICE) has recommended Elfabrio (pegunigalsidase alfa) as a treatment for Fabry disease in adults.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Janssen has filed a marketing authorisation application with the European Medicines Agency for erdafitinib to treat urothelial carcinoma.
Fierce Pharma
SEPTEMBER 11, 2023
Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.
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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
SEPTEMBER 11, 2023
The agreement allows Sandoz exclusive marketing rights for the inflammatory bowel disease therapy in Europe and North America.
BioPharma Reporter
SEPTEMBER 11, 2023
TherageniX, a University of Nottingham spin out pioneering a dry powder gene therapy formulation for bone graft augmentation, has been awarded a Â995,000 grant from Innovate UK.
Fierce Pharma
SEPTEMBER 11, 2023
Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).
BioSpace
SEPTEMBER 11, 2023
The first-in-class antibody-drug conjugate—in combination with Merck’s Keytruda—has shown promising results in a Phase II study of patients with metastatic non-small cell lung cancer.
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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
SEPTEMBER 11, 2023
After plotting a course to grow by leveraging its biosimilar expertise, Sandoz has inked a deal to get involved in one of the industry's next major biosim debuts. | The blockbuster inflammatory med's patents begin to expire this year, leaving biosimilar makers scrambling for a piece of the large market. Versions from Amgen, Teva and Alvotech are expected to launch in early 2025.
BioSpace
SEPTEMBER 11, 2023
Following a Phase II review, Novartis has cut the development of a gene therapy candidate for geographic atrophy. In June, the company sold a dry eye disease drug to Bauch + Lomb for $1.75 billion.
Pharma Times
SEPTEMBER 11, 2023
The platform will be used to advance the effectiveness of antibiotics - News - PharmaTimes
BioSpace
SEPTEMBER 11, 2023
A thorough reassessment of the confounders between FibroGen’s trials is necessary to salvage the company's Duchenne Muscular Dystrophy program and regain investor confidence.
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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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