In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
The massive deal Jounce Therapeutics Inc. has cut with Gilead Sciences Inc., an agreement that could eventually add up to about $805 million, will strengthen Jounce’s ability to develop its pipeline and choose new partners, the company’s CEO and president told BioWorld.
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
Times have changed at Ionis Pharmaceuticals Inc. since it spun out Akcea Therapeutics Inc. in 2015. The company’s evolution is such that Ionis is now ready to bring Akcea back into the fold by acquiring the remaining 24% of its affiliate.
Athira Pharma Inc.’s proposed $100 million IPO, along with a filing by Virios Therapeutics LLC to raise $35 million on Aug. 28, helped propel a supercharged amount of investment in 2020 that shows no sign of slowing. The pace is unusually swift this year despite hindrances from COVID-19. The total value of IPOs so far in 2020 is $12.95 billion, with 54 completed, easily outpacing 2019’s $8.64 billion.
With the FDA approval of Cassiopea SpA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, the European company hailed it as the first acne drug in 40 years with a new mechanism of action.
Strong top-line results from Immunovant Inc.’s phase IIa clinical trial of IMVT-1401 in treating moderate to severe generalized myasthenia gravis increased the competition with Momenta Pharmaceuticals Inc. and Argenx SE in the crowded anti-FcRn space.
Privately held Alzheon Inc. picked up a $47 million grant from the NIH’s National Institute on Aging that will last over five years to support a phase III clinical trial of its oral brain-penetrant small molecule ALZ-801 to treat Alzheimer’s disease.
Now that Ovid Therapeutics Inc.’s and Takeda Pharmaceutical Co. Ltd.’s phase II study of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) has produced positive top-line data, Ovid is planning the drug’s phase III clinical trial while pricing a $50 million common stock offering.
