Three candidates for FDA approval remain on BioWorld’s Drugs on Deck list for March, all of which have PDUFA dates scheduled for this month, even though most of the agency’s attention as of late is on the COVID-19 pandemic.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
Several companies are awaiting regulatory decisions from the FDA over the next several months. BioWorld will periodically feature a chart of Drugs on Deck that show upcoming PDUFA dates. The current month includes four products that are waiting in the wings to treat diverse indications such as multiple sclerosis, migraine and renal disease.
Lessons learned from development of hepatitis C therapies could be applied to the underserved hepatitis B population, potentially leading to a functional cure through a combination of optimized drugs that attack the virus from different angles. That is the mission of 2-year-old Aligos Therapeutics Inc., a South San Francisco-based startup focused on liver-related diseases.
A list of biopharma companies and nonprofit entities, including academia, working feverishly to find a vaccine or antiviral treatment to address the rapidly spreading coronavirus, now known as COVID-19, has more than doubled, increasing from about 30 a few weeks ago to 71 as of March 6.
A list of biopharma companies and nonprofit entities, including academia, working feverishly to find a vaccine or antiviral treatment to address the rapidly spreading coronavirus, now known as COVID-19, has more than doubled, increasing from about 30 a few weeks ago to 71 as of March 6.
In a flurry of catch-up following the coronavirus outbreak in China, a number of biopharma companies have announced development within the last few weeks to address the ever-spreading infection known as COVID-19.
In a flurry of catch-up following the coronavirus outbreak in China, a number of biopharma companies have announced development within the last few weeks to address the ever-spreading infection known as COVID-19.
At 26 years old, Karen Jury stood before a class of elementary students as her right arm tingled before falling completely numb. That led to a conversation with her doctor. Years of migraine headaches and a recurring sensation of shock waves throughout her body, simply from the turn of her head, resulted in a scheduled spinal tap and an MRI. She received a diagnosis of Arnold-Chiari malformation, a structural defect in the base of the skull and cerebellum.
Jaime Sanders was just a child, barely 8 years old, when a debilitating condition kept her inside from recess and home from school. “I would get these intense headaches focused on the left side like a sledgehammer was banging on my head,” she said.
