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Takeda, Zedira and Dr. Falk Pharma inked a collaboration and licensing agreement to develop TAK-227, an investigational therapy for patients with celiac disease, an autoimmune disorder characterized by inability to tolerate gluten. The therapy currently is undergoing a phase 2b trial. Read More
Gilead subsidiary Kite has acquired an exclusive global license for Refuge Biotechnologies’ second-generation CAR-T gene editing platform to develop blood cancer treatments. Read More
In a pair of recent lawsuits over proposed generics, Takeda has sued Apotex for allegedly infringing on its leukemia drug Iclusig (ponatinib) and Eli Lilly has filed suit against Dr. Reddy’s over alleged infringement of its osteoporosis therapy Forteo (teriparatide). Read More
Not enough elderly patients are included in drug trials targeting some of their most common illnesses, a new study by FDA researchers concludes. Read More
As part of its commitments for reauthorization of its user fee programs, the FDA today officially launched a new initiative to help sponsors of new drug and biologics products incorporate real-world evidence (RWE) into their clinical trials. Read More
FDA Commissioner Robert Califf warned that the agency’s accelerated approval pathway is in dire need of reform during remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit held earlier this week. Read More
An FDA advisory committee recommended 14-1 yesterday that the FDA withdraw accelerated approval for Covis Pharma’s preterm birth drug Makena. Read More