Bio Pharma Dive
JANUARY 22, 2024
New details of the proposed acquisitions show there were multiple interested buyers, which, according to some analysts, could set the stage for more dealmaking.
Pharmaceutical Technology
JANUARY 22, 2024
On 18 January 2024, US-based biotech CG Oncology announced it was looking to raise $200m in an upcoming initial public offering (IPO), which will be the first for the biotech sector in 2024.
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Bio Pharma Dive
JANUARY 22, 2024
Trodelvy didn’t outperform chemotherapy in a large study of people with a common lung tumor, a setback that sent company shares down by double digits.
Pharmaceutical Technology
JANUARY 22, 2024
The UK NICE recommends Pfizer's talazoparib, marketed as Talzenna, to treat a specific type of locally advanced or metastatic breast cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 22, 2024
Neuroscientists at Washington State University think they have figured out why cannabis is so notorious for causing the ‘munchies’ among users. Their research on mice is the first to investigate how cannabis impacts the real-time activity of brain regions that control appetite.
Pharmaceutical Technology
JANUARY 22, 2024
Sandoz has agreed to acquire Coherus Biosciences' CIMERLI ophthalmology franchise, including proprietary software.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 22, 2024
The US FDA has granted fast track designation to Kyverna Therapeutics’ KYV-101 for the treatment of multiple sclerosis (MS).
Rethinking Clinical Trials
JANUARY 22, 2024
What happens to a pragmatic trial intervention after the study ends? In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program's completed pragmatic clinical trials summarize the posttrial interpretation of their trials' results and consider the factors that influenced the sustainment or de-implementation of the studies' interventions.
Bio Pharma Dive
JANUARY 22, 2024
The divestment, which includes sales and reimbursement staff, is part of Coherus plan to shift resources toward its R&D work in oncology.
Pharmaceutical Technology
JANUARY 22, 2024
Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 22, 2024
The Indian Institute of Science (IISc) is now developing a heat-tolerant vaccine that can offer protection against different strains of SARS-CoV-2 – both current and future variants. The researchers have proved that their vaccine candidate is effective against all current strains of SARS-CoV-2 and can be quickly adapted for future variants as well.
Pharmaceutical Technology
JANUARY 22, 2024
An analysis of GlobalData’s analyst consensus sales and forecast database reveals that three out of 12 novel oncology brands that launched globally from November 2022 to December 2023 have the potential to reach blockbuster sales.
Fierce Pharma
JANUARY 22, 2024
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
Pharmaceutical Technology
JANUARY 22, 2024
Obesity drugs are in such high demand in developed markets that there is a shortage of Novo Nordisk’s Wegovy and Ozempic, and Eli Lilly’s Mounjaro and Trulicity,
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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
Drug Patent Watch
JANUARY 22, 2024
A recent article published in Health Affairs, delves into the Federal Trade Commission’s (FTC) concerns regarding the inclusion of improper patents in the FDA’s Orange Book by pharmaceutical manufacturers. The… The post Legislative Proposals to Tackle Improper Pharmaceutical Patents in the Orange Book appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JANUARY 22, 2024
How many patents did F. Hoffmann-La Roche submit related to cybersecurity last quarter, and how many were granted? Discover the latest information here.
Fierce Pharma
JANUARY 22, 2024
Even as Gilead looks to become an oncology powerhouse in the coming years, the company on Monday recorded a major setback for its antibody-drug conjugate (ADC) Trodelvy. | The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer.
Pharmaceutical Technology
JANUARY 22, 2024
How many patents did Bayer submit related to artificial intelligence last quarter, and how many were granted? Discover the latest information here.
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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
JANUARY 22, 2024
Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Food and Drug Administration’s crosshairs, Reuters first reported. | Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance.
Pharmaceutical Technology
JANUARY 22, 2024
NS Pharma has received orphan drug designation from the European Commission for NS-229 for eosinophilic granulomatosis with polyangiitis.
Outsourcing Pharma
JANUARY 22, 2024
An online portal enabling people worldwide to find and express interest in clinical trials has been launched by Clinical Trial Media, a clinical trial participant recruitment and retention company.
Pharmaceutical Technology
JANUARY 22, 2024
GB-2064 is under clinical development by Galecto and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).
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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
JANUARY 22, 2024
A digital records system has saved Priory, the UKâs leading independent provider of mental health services, thousands of hours freeing them up for direct resident support.
Pharmaceutical Technology
JANUARY 22, 2024
Johnson & Johnson (J&J) has received full approval from the US FDA for BALVERSA to treat metastatic urothelial carcinoma (mUC).
Outsourcing Pharma
JANUARY 22, 2024
Bora Pharmaceuticals is set to acquire US pharma manufacturer Upsher-Smith Laboratories for up to $210 million, it says, to fuel global expansion.
Pharmaceutical Technology
JANUARY 22, 2024
The French company will start the confirmatory trial for its cancer vaccine Tedopi as a second-line lung cancer therapy in Q2 2024.
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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.
pharmaphorum
JANUARY 22, 2024
Sandoz makes its first acquisition since spinning out of Novartis, buying a Lucentis biosimilar from Coherus that will boost its position in the US market.
Pharmaceutical Technology
JANUARY 22, 2024
SGN-1 is under clinical development by Guangzhou Sinogen Pharmaceutical and currently in Phase II for Metastatic Ovarian Cancer.
pharmaphorum
JANUARY 22, 2024
A hearing will get underway in Delaware later today in the latest phase of GSK’s attempts to defend itself from allegations that its Zantac drug caused cancer in patients.
Pharmaceutical Technology
JANUARY 22, 2024
More than 3.4 million children are unprotected against the disease, as NHS urges more people to book missed MMR vaccinations.
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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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