Tags : Otsuka

Insights+

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More

Regulatory

Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval

Shots: The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval Inqovi is a novel […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (April 20 -24, 2020)

1. Sanofi Receives the US FDA’s Approval for its MenQuadfi Meningococcal (MenACWY) Conjugate Vaccine Published: Apr 23, 2020 | Tags: Sanofi, Receives, US, FDA, Approval, MenQuadfi, Meningococcal, MenACWY, Conjugate Vaccine 2.  Takeda to Divest Select OTC and Non-Core Assets in Europe to Orifarm for $670M Published: Apr 24, 2020 | Tags: Takeda, Divest, Select OTC and […]Read More