Pharma Mirror
SEPTEMBER 19, 2021
Milan, BMG Pharma – a biotech and B2B company headquartered in Milan with its chemical plant in Torviscosa (Italy) that exports its medical products to more than 80 countries – has signed a development and commercial agreement with HTL, a leading biotech and industrial player in the development and production of innovative, pharmaceutical-grade biopolymers.
pharmaphorum
SEPTEMBER 19, 2021
Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the drug in March.
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BioSpace
SEPTEMBER 19, 2021
Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
pharmaphorum
SEPTEMBER 19, 2021
AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they reported top-line results last month – and a look at the full data set reveals why. In the DESTINY-Breast03 trial, Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or death compared to Kadcyla (trastuzumab emtansine) by 72% in patients with HER2-positive, advanced breast cancer who had previously tr
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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
BioSpace
SEPTEMBER 19, 2021
Lung cancer is a particularly difficult cancer to treat, but several companies presented very promising data at this year’s European Society of Medical Oncology (ESMO) Congress 2021.
NY Times
SEPTEMBER 19, 2021
Dozens of human rights and other advocacy groups urge President Biden to back a $25 billion investment that would produce 8 billion Covid-19 vaccine doses within a year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
SEPTEMBER 19, 2021
Physics researchers at the University of Bath in the UK discover a new physical effect relating to the interactions between light and twisted materials – an effect that is likely to have implications for emerging new nanotechnologies in communications, nanorobotics and ultra-thin optical components. Credit: Ventsislav Valev and Lukas Ohnoutek Physics researchers at the University […].
BioSpace
SEPTEMBER 19, 2021
Patients with different forms of breast cancer could soon have different treatment options following multiple presentations at the European Society of Medical Oncology meeting.
Scienmag
SEPTEMBER 19, 2021
Lugano, Switzerland, 19 September 2021 – A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking research presented at the ESMO Congress 2021. (1,2) The PEACE-1 and STAMPEDE studies found that the addition of abiraterone acetate plus prednisolone (AAP) to standard therapy lengthened survival compared to standard therapy alone.
BioSpace
SEPTEMBER 19, 2021
?Researchers from the Institute for Systems Biology observed 105 participants and found that failing or succeeding at shedding pounds is linked to one's gut microbiome.
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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
BioTech 365
SEPTEMBER 19, 2021
Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer With the MONALEESA-2 final analysis, only … Continue reading →
BioSpace
SEPTEMBER 19, 2021
Mirati Therapeutics tapped David Meek, the former chief executive officer of Ipsen, as its new CEO. He replaces company founder Charles Baum.
Scienmag
SEPTEMBER 19, 2021
Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1) Credit: ESMO Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal wome
BioSpace
SEPTEMBER 19, 2021
The company announced Friday that clinical studies have been placed on hold following the development of tumors in mice in a non-clinical study.
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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.
BioTech 365
SEPTEMBER 19, 2021
Santhera Secures CHF 45 Million in Funding and Announces Preliminary First Half-Year 2021 Financial Results Santhera Secures CHF 45 Million in Funding and Announces Preliminary First Half-Year 2021 Financial Results NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES … Continue reading →
BioSpace
SEPTEMBER 19, 2021
With a conference the size of ESMO, it’s impossible to cover all the exciting news, but here are many of the highlights. Here’s a look.
BioTech 365
SEPTEMBER 19, 2021
HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors Following surufatinib launch in China in January 2021; NDA acceptance by the … Continue reading →
BioSpace
SEPTEMBER 19, 2021
It is the largest venture capital fund in Europe focused on the life sciences.
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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.
BioTech 365
SEPTEMBER 19, 2021
Genmab and Seagen Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021 Genmab and Seagen Present Interim Results From the innovaTV 205 Study for … Continue reading →
BioSpace
SEPTEMBER 19, 2021
One constant throughout the conversation is that the industry is at a different stage of adapting to the “new normal.
BioTech 365
SEPTEMBER 19, 2021
ESMO late-breaking data show Libtayo® (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC ESMO late-breaking data show Libtayo® (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC … Continue reading →
BioSpace
SEPTEMBER 19, 2021
Sheila Gujrathi, M.D. will join the board of directors as executive chair, while Jörn Drappa, M.D., Ph.D. will serve as chief medical officer.
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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.
BioTech 365
SEPTEMBER 19, 2021
Sorrento Announces an Independent Real-World Study That Reports Superior Sensitivity Results in Detecting COVID-19 Virus Infections in All-Comer General Population by COVISTIX as Compared to a Globally Leading Rapid Antigen Test Sorrento Announces an Independent Real-World Study That Reports Superior … Continue reading →
BioSpace
SEPTEMBER 19, 2021
Zai Lab Limited calls itself a growing global biopharmaceutical company and is continuing to live up to that claim with its latest expansion announcement.
BioTech 365
SEPTEMBER 19, 2021
Junshi Biosciences Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19 Junshi Biosciences Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19 … Continue reading →
Drug Patent Watch
SEPTEMBER 19, 2021
This chart shows the pharmaceutical companies with the most patents in Czech Republic. Patents must be filed in each country (or, in some cases regional patent office) where patent protection…. The post Which pharmaceutical companies have the most drug patents in Czech Republic? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioTech 365
SEPTEMBER 19, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: ESMO: Mirati pulls away from Amgen in colorectal cancer with rival KRAS drug.
BioSpace
SEPTEMBER 19, 2021
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.
BioTech 365
SEPTEMBER 19, 2021
Verastem Oncology Announces Updated Investigator-Sponsored Phase 1/2 FRAME Study Data of VS-6766 with Defactinib in Low-Grade Serous Ovarian Cancer Showing Encouraging Response Rates and Progression-Free Survival Presented at ESMO 2021 Verastem Oncology Announces Updated Investigator-Sponsored Phase 1/2 FRAME Study Data … Continue reading →
BioSpace
SEPTEMBER 19, 2021
The vote to offer a booster to those 65 and older, as well as immunocompromised individuals at high risk of developing severe COVID-19, was a unanimous “yea” at 18-0.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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