The Mariposa study showed that a combination of two Johnson & Johnson (J&J) drugs, Rybrevant, and lazertinib, was successful in improving progression-free survival in a common type of metastatic lung tumor, compared to AstraZeneca's Tagrisso. These interim results have been closely […]
Galecto Laying Off 70% of Staff and Exploring Strategic Alternatives after Failed Lung Disease Drug Trial
Boston-based biotech firm Galecto plans to lay off 29 employees, approximately 70% of its workforce, after its lung disease drug candidate GB0139 failed in a phase IIb trial. Following the unsuccessful trial and predicted resource changes hinted at in mid-August, Galecto is now pursuing strategic […]
Higher Suicide Risk Among Health Care Workers, Especially Women: Study Reveals
A new study in the Journal of the American Medical Association suggests that health care workers, particularly registered nurses, health technicians and support workers, have a significantly higher risk of suicide than the general population. This is the first study to encompass all roles within the […]
AstraZeneca and Daiichi Sankyo Plan Approval Filing for Breast Cancer Treatment Following Promising Trial Results
AstraZeneca and Daiichi Sankyo plan to seek approval for their breast cancer treatment datopotamab deruxtecan (Dato-DXd) following a clinical trial that revealed improved patient outcomes. The study included over 700 participants with inoperable or metastatic HR-positive, HER2-low, or negative […]
FDA Updates Guidelines on Using Single Clinical Investigation as Confirmatory Evidence for New Drug Approval
The FDA has issued a draft guide to clarify how evidence from a sole clinical investigation can be used as substantial evidence to approve new drugs. This draft guide is in continuation of guidance from 1998 and 2019 and specifies that the amount of confirmatory evidence required will depend on the […]
Gender-Affirming Care: The Challenges and Ethics of Randomized Controlled Trials
To offer gender-affirming care, such as hormone treatments, clinicians often need to manipulate medical coding systems and justify these treatments with randomized controlled trials (RCTs). The gold standard of medical research, RCTs involve assigning participants randomly to either receive a […]
Alexion Pharmaceuticals Nears $125M Settlement in Class Action Lawsuit Over Alleged Unethical Sales Practices
A 2016 class action lawsuit against pharmaceutical company Alexion, which claimed that the company's unethical sales practices led to a decline in its stock price, might conclude after both parties proposed a $125 million settlement. The lawsuit represented shareholders who bought stocks between […]
Cognitive Ability Tied to COVID-19 Vaccination Rates
The study published in the Journal of Health Economics investigated a link between an individual's cognitive ability and their decision to receive the COVID-19 vaccination. The researchers found that people with higher cognitive abilities were likely to get vaccinated faster than those with lower […]
FDA Approves Updated Covid-19 Booster Shots from Pfizer/BioNTech and Moderna
The FDA has approved updated Covid-19 booster shots from Pfizer/BioNTech and Moderna for the fall season. The CDC's vaccine advisors will likely recommend the updated boosters soon, followed by a final decision on release by CDC Director Mandy Cohen. The safety, effectiveness, and manufacturing […]
AstraZeneca Inks $42M Deal with Verge Genomics for AI-Driven Drug Discovery in Rare Neurodegenerative Diseases
Verge Genomics, an AI-drug discovery biotech company, has entered into a $42 million deal with AstraZeneca to discover new treatments for rare neurodegenerative diseases. Over four years, Verge will collaborate with AstraZeneca's rare disease division, Alexion, and is eligible for a further $840 […]
Major Transformations Expected in Clinical Trials Industry with Projected Growth to USD 73.2 Billion by 2028
The clinical trials industry is predicted to evolve significantly, with advancements in technology like AI, machine learning, and blockchain that will significantly improve trial design, patient recruitment, and data analysis. Experts expect patient-centric approaches, decentralized trials, and […]
Seagen and Nurix Partner to Develop New Cancer Therapy, Deal Could Reach $3.4 Billion
Seattle-based biotech Seagen will partner with Nurix to develop degrader-antibody conjugates (DACs), a new type of cancer therapy. Seagen is paying $60 million upfront, and the deal could total up to $3.4 billion, including milestone payments. DACs deliver a molecule to cancer cells that mark […]
IPG Health Debuts Diversity Initiative for Clinical Trials
IPG Health announced a new clinical trial diversity offering aimed at ensuring equitable representation across various aspects of diversity, including race, gender, age, and other intersectional groups in clinical trials. This offering is part of its EDI+You strategy, which seeks to provide […]
Cellares Secures $255M in Series C Round of Funding
Cellares, a cell therapy manufacturer based in South San Francisco, announced a $255 million series C investment round to finish constructing its commercial-scale cell therapy manufacturing facility in Bridgewater, NJ. Koch Disruptive Technologies led the funding round and included pharmaceutical […]
FDA Accelerates Review of HuidaGene’s Treatment for Inherited Blindness
The US Food and Drug Administration (FDA) has granted HuidaGene Therapeutics a rare pediatric disease designation (RPDD) to accelerate the development and review of its gene therapy candidate, HG004. This one-time gene replacement drug aims to combat inherited retinal diseases (IRDs) caused by […]
BridgeBio’s Experimental Results Boosts Company Shares by 65%
BridgeBio Pharma Inc's experimental drug, acoramidis, for rare heart disease, has shown significant improvement in a late-stage study, boosting its market shares by 65%. Acoramidis functions to prevent heart failure by addressing anomalous protein deposits in the heart. It is expected to compete […]
Meet inVentiv Health experts at DIA
We are a global provider of best-in-class clinical development and comprehensive commercialization services to the biopharmaceutical industry. Visit us at the event: booth #1517. […]
Increase your knowledge base around conducting non-interventional studies in Europe.
For years, industry stakeholders have been hoping for a clearer definition of non-interventional studies (NIS), which observe patients treated under real-life conditions to obtain information on a drug’s safety and effectiveness. NIS are the “untamed beast,” and each must be approached […]
Your Roadmap to Patient-Focused Trials.
Download the FDA Roadmap App Presented by PHT Corporation. Available on the Apple App Store and Android App on Google. […]
Is It Time to Retire the Randomized Controlled Trial?
ISPOR 19th Annual International Meeting - Montreal Second Plenary Session Read more here. […]
Free White Paper! Learn more about Clinical Trials in Russia
inVentiv Late Stage Clinical Trials
inVentiv Health Clinical Late Stage Clinical Trials 3.24.2014
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Ebook: Top Disruptive Innovations in Clinical Trials – 2nd Edition
