In Depth 15 Apr 2024
Does the FDA need to tighten its grip on drug trials in the U.S.?
Studies suggest that the FDA has been less rigorous with its drug approval standards. We looked at the current state of the approval process.
FDA
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How to build a career as an investigator at the FDA?
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Eight CAR-T cell therapy companies you should know about
Discover eight promising biotech companies that are advancing their CAR T cell therapy candidates in the clinic.
News and Trends 8 Jan 2024
Is the biotech industry poised for recovery in 2024?
The past few years have been challenging for the industry but 2024 might be the year marking the biotech recovery.
More News! 4 Dec 2023
FDA CAR-T cell therapy warning: Are T cells malignant?
Chimeric antigen receptor (CAR) T cell therapies have emerged as groundbreaking treatments for various hematologic cancers, demonstrating remarkable efficacy in targeting specific cancer cells. However, recent concerns raised by the U.S. Food and Drug Administration (FDA) have sparked an investigation into potential risks associated with these therapies. The FDA CAR-T cell therapy warning comes at […]
Opinion 1 Nov 2023
Could this be the start of a new era for PI3K drugs?
There is hope that a rich biotech pipeline will produce a second generation of PI3K drugs after issues with the first generation from the class had brought up concerns. Phosphoinositide 3-kinases (PI3K) drugs work by inhibiting a pathway that plays a role in cell metabolism, growth, proliferation and survival that has become dysregulated in almost […]
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In Depth 26 Oct 2023
Behind closed doors: The unseen controversies and scandals in Alzheimer’s drug trials
Alzheimer’s disease is the most common form of dementia – which currently affects more than 55 million people globally – making up 60% to 70% of cases. It is a complex disease, encompassing multiple interrelated and progressive destructive processes in the brain, resulting in neuron damage that extends to parts of the brain that enable […]
News and Trends 22 Sep 2023
U.S. approval for psychedelic drug MDMA nears after success in clinic
The psychedelic drug MDMA edges closer towards FDA approval for the treatment of post-traumatic stress disorder (PTSD) in the U.S., after promising results of a trial were published. This comes after Australia became the first country to allow doctors to prescribe the drug to those struggling with mental health disorders like PTSD and depression. Recognizing […]
News and Trends 28 Jul 2023
FDA grants breakthrough therapy designation to Duchenne muscular dystrophy treatment
The U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS Pharma Inc.’s NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy. The breakthrough designation is based on results from a first-in-human, investigator-initiated clinical trial conducted in Japan. In June 2023, NS-089/NCNP-02 was granted Rare […]
News and Trends 25 Jul 2023
Molecure raises $12M and gets FDA clearance for pulmonary sarcoidosis trial
Molecure S.A. has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application to conduct phase II clinical testing of OATD-01. The announcement follows the company closing a secondary public offering and entering into subscription agreements for all 2,776,000 H-shares offered by way of private placement, within the […]
News and Trends 18 Jul 2023
FDA approves Beyfortus ahead of 2023-24 RSV season
The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The approval also covers children up to 24 months of age who remain vulnerable to severe […]
News and Trends 30 Jun 2023
FDA approves BioMarin gene therapy for hemophilia A
BioMarin Pharmaceutical Inc. has announced that the United States Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The […]
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