BioMarin updated several of the company’s gene therapy programs on February 17 following a September 2021 update, when the drug manufacturer reported the U.S. Food and Drug Administration had placed a clinical hold on the BMN 307 Phearless Phase I/II trial.
FDA Awards Fast Track Designation to Multiple Non-Covid-19 CandidatesAcid Disorders, Acute repetitive seizures, Coronavirus Disease (COVID-19) Pandemic, Fast Track Designation, FDA, Gene Therapy, Hypogammaglobulinemia, Imaging Agents, Infections and Myelokathexis) syndrome, Methylmalonic Acidemia (MMA), MPS Type VI, Non-Small Cell Lung Cancer (NSCLC), Phenylketonuria (PKU), Primary Mitochondrial Myopathy (PMM), Solid Tumors, WHIM (Warts
While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.
BioSpace reviews some of the more interesting scientific studies recently published.
A Paris-based prosecutor initiated an investigation into Sanofi over the company’s drug Depakine, which is on the market for epilepsy and bipolar disorder.
Prior infection with dengue, a mosquito-borne disease that infects nearly 400 million people a year, could reduce the risk of contracting Zika nearly by half, U.S. and Brazilian researchers reported.
EMA committee recommends restrictions on fluoroquinolone, quinolone antibioticsAntibiotics, Birth Defects, Blockbusters, Bones, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, FDA/Regulatory, Fluoroquinolones, Integrase inhibitors, Muscles, Nervous System, Pharmacovigilance Risk Assessment Committee (PRAC), Quinolone, Tendons
The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.
Japan’s Takeda Pharmaceutical moved ahead in the race to develop a vaccine for the mosquito-borne Zika virus, with the start of a clinical trial program backed by the U.S. government.
Pfizer defeated an effort to revive 300+ lawsuits alleging that its antidepressant Zoloft causes cardiac birth defects in children when taken by women during early pregnancy.
A report shows the kind of damage Zika infections can do to the developing brain – damage that goes well beyond that caused by the devastating birth defect microcephaly.
Zafgen Inc said the U.S. Food and Drug Administration was putting a late-stage study testing its experimental obesity drug on complete hold after a second patient died during the trial. […]