First-in-class Tazverik launched for rare sarcoma, wider use will drive...
Epizyme’s first-in-class EZH2 (enhancer of zeste homolog 2) inhibitor Tazverik (tazemetostat) has become the first therapy to be made available in the U.S. for the treatment of epithelioid sarcoma...
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Medicines that treat high prevalence conditions offer hope to many as the...
Cortellis identifies new drugs for treating indications for breast cancer, lymphoma, multiple sclerosis (MS) and migraine touted for commercial and clinical success PHILADELPHIA & LONDON,...
View ArticleEleven potential blockbuster drugs offer hope, threaten budgets
Crowned by a potential cure for severe hemophilia A, which could become the most expensive drug ever, a new list of 11 medicines expected to generate $1 billion-plus in annual sales by the end of 2024...
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Clarivate Analytics Closes Acquisition of Decision Resources Group
— Creates a leading information insight solutions provider to the Life Sciences industry, helping them improve human lives — London, UK, & Philadelphia, US, March 2, 2020 – Clarivate Analytics plc...
View ArticleCentre for Innovation in Regulatory Science Awarded a $1.09m Grant to Help...
Metrics will inform, monitor and assess the effectiveness of regulatory optimisation programmes London, UK. March 9, 2020: The Centre for Innovation in Regulatory Science (CIRS), a neutral and...
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Biopharma M&A activity in Q4 2019 47% higher than in Q4 2018
Understand the key drivers and trends of Q4 2019 biopharma business development activities, and get a preview of what’s in store for Q1 2020. Total disclosed biopharma mergers and acquisitions...
View ArticleCOVID-19 testing: FDA guidance update
As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings, and...
View ArticleHow can we improve and accelerate patients’ access to medicines in low and...
As the World Health Organization (WHO) reports that one third of the world’s population does not have timely access to the healthcare products they require, the efficient, predictable and speedy...
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COVID-19: Scientific innovation will help us beat this virus
“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” Marie Curie The Coronavirus (COVID-19) pandemic has taken the world by...
View ArticleDo EMA and FDA review outcomes for new active substances (NASs) align?
In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities...
View ArticleFDA to expedite public release of guidance documents related to COVID-19
On March 25, 2020, the FDA announced an expedited process for making COVID-19-related guidance documents available to the public [Federal Register, 25-March-2020 (IDRAC 308168)]. The intent is to...
View ArticleTreating a pandemic: Drug repurposing, expanded access and emergency use...
As the COVID-19 global pandemic rages on, clinicians and politicians alike have responded enthusiastically to the potential for using known, already-approved drugs as treatments for SARS-CoV-2...
View ArticleThe trials must go on: Conducting clinical studies during the COVID-19 pandemic
Amid the COVID-19 pandemic sweeping across the globe, clinical trials for drugs, medical devices, and biological products still need to continue for other diseases and medical conditions. To address...
View ArticleFDA unveils emergency investigational COVID-19 convalescent plasma...
To address the rapidly changing landscape of the COVID-19 outbreak in the US, on March 24, 2020, the FDA announced an emergency investigational new drug (IND) application program that allows healthcare...
View ArticleFDA unveils emergency investigational COVID-19 convalescent plasma...
To address the rapidly changing landscape of the COVID-19 outbreak in the U.S., on March 24, 2020, the FDA announced an emergency investigational new drug (IND) application program that allows...
View ArticleFDA to expedite public release of guidance documents related to COVID-19
The FDA has announced an expedited process for making COVID-19-related guidance documents available to the public (Federal Register, 25-March-2020). The intent is to “allow the agency to rapidly...
View ArticleThe trials must go on: Conducting clinical studies during the COVID-19 pandemic
While it may seem like the whole world is on pause due to COVID-19, clinical trials in the U.S. can continue with adjustments to conditions or protocols while still adhering to regulations and ensuring...
View ArticleTreating a pandemic: Drug repurposing, expanded access and emergency use...
As the COVID-19 global pandemic rages on, clinicians and politicians alike have responded enthusiastically to the potential for using known, already-approved drugs as treatments for SARS-CoV-2...
View ArticleCombating COVID-19: Insights from the BIO Europe conference
The Cortellis team regularly attends industry conferences to provide summaries, updates and insights on what’s happening across the life sciences R&D landscape. Here we summarize select proceedings...
View ArticleThe COVID-19 pandemic: European regulators respond
The COVID-19 pandemic is spreading around the world with, as of this writing, more than one million cases globally and more than 500,000 cases in Europe alone. Here we summarize how The European...
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