On Tuesday, GSK announced that it had reached an agreement to acquire Bellus Health Inc. for nearly $2 billion. Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant,...
On April 16, 2023, Merck announced plans to expand its immunology portfolio by acquiring Prometheus Biosciences, a biotechnology company focused on immune-mediated diseases. The deal, valued at $10.8...
On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...
An article published in the New England Journal of Medicine found that post-exposure doxycycline reduces sexually transmitted infection (STI) rates by two-thirds. The study found that men who have sex...
On April 6, 2023, the FDA Commissioner Robert M. Califf, MD, and Chief Scientist Namandjé Bumpus, PhD, announced the organization’s decision to withdraw the approval of Makena...
On March 24, 2023, the FDA issued a draft guidance on the clinical trial considerations for the accelerated approval of oncology drugs. The proposed recommendations include guidelines to fortify and...
Earlier this year, Nectin Therapeutics Ltd, a clinical biotechnology company, announced a collaboration with Merck, a leading global pharmaceutical company, to develop a treatment regimen for cancer patients. The clinical trial combines a...
In a study published in Nature on March 15, 2023, researchers achieved complete or nearly complete remission in 18 patients with KMT2A-rearranged or NPMI-mutant leukemia. The phase 1 clinical trial...
Medicine regulation, review, and authorization are critical tools for bringing drugs to market, monitoring patient safety, and ensuring the best health outcomes. While regulatory guidance can vary globally, comparing protocols can help...
In a recent research letter published in JAMA Network Open, Chris A. Rees, MD, MPH, and his colleagues analyzed how pediatric clinical trial results are disseminated or made publicly available. Rees...
On Tuesday, Pfizer announced that the FDA accepted for review its Biologics License Application (BLA) for the company’s respiratory syncytial virus (RSV) vaccine candidate RSVpreF. Depending on...
Last month, Sun Pharma announced that it would pay $8 per share to acquire Concert for a total of $576 million in cash.
During the first three quarters of 2022, Concert recorded a net loss of nearly...
Despite having a high risk of failure, the clinical trial process can cost millions of dollars to complete. For clinical research organizations and sponsors, a clinical trial budget is critical in determining whether a clinical trial is...
Clinical trial significance and success throughout the COVID-19 pandemic have inspired the launch of clinical trial branches for existing companies, such as Walgreens, and multiple startups. However, it is critical to note that while some...
The Orphan Drug Act of 1983 defines a rare disease as a medical condition that impacts less than 200,000 people in the United States. Despite the restrictive nature of this definition, the Genetic and Rare Diseases Information Center of...
Before the FDA Modernization Act 2.0 was passed in December 2022, the US government required that all investigational drugs be tested on animals before they could advance to human trials. Although this act does not ban animal testing, it...
While several different approaches are used during clinical research, traditional biomedical research involving animal testing to develop new treatments and drugs may be a strategy of the past after the FDA Modernization Act 2.0 was signed...
In a recent press release, the HIV Vaccine Trials Network (HVTN) announced that the Mosaico study, an investigational HIV vaccine study, was discontinued at phase 3 after an interim review by the Data...
Like developing, launching, and marketing any product, drug development and launching is a complex, costly, and intricate process. However, unlike other markets, the pharmaceutical industry has an added layer of complexity associated with...
On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...
