Incyte nabs priority review for bile duct cancer drug; Temasek shows interest in another Woodford darling — report
→ Incyte’s decision to stop co-funding baricitinib in favor of other pipeline opportunities is paying off, as the FDA grants priority review to pemigatinib in a type of previously treated, locally advanced or metastatic cholangiocarcinoma. Patients currently have “limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” said Peter Langmuir, group vice president for targeted therapeutics. The drug inhibits fibroblast growth factor receptor, or FGFR, and has been shown to induce an overall response rate of 36% with a median duration of response of 7.5 months among patients with FGFR2 fusions or rearrangements. The PDUFA date is set for May 30, 2020.
→ After extending a $90 million lifeline to BenevolentAI, Singapore’s Temasek is reportedly eyeing another biotech unicorn in the portfolio of the struggling fund formerly managed by Neil Woodford. The firm is in talks to invest in DNA sequencing player Oxford Nanopore, the Sunday Times reported. The high flying Oxford spinout has been looking to raise £125m ($161 million) after abandoning plans to go public, according to the paper, but it’s unclear whether Temasek wants to participate in that financing or a separate arrangement.
→ Four months after Amgen and Allergan launched the first Herceptin biosimilar in the US, Mylan and Biocon are catching up with their own copycat, Ogivri. Despite scoring an FDA approval earlier than rivals, their settlement with Roche prevented them from rolling out the drug until today. It marks the second biosimilar that Mylan is marketing in the US through its partnership with Biocon, following the arrival of Neulasta knockoff Fulphila. Ogivri is also approved in more than 80 countries worldwide, the companies said.
→ As Intercept turns the final regulatory corner on its experimental NASH drug, the biotech is promoting Jason Campagna to the CMO role. Having joined as the NASH program leader in 2016 from The Medicines Company, Compagna will now oversee strategic medical and scientific moves while the R&D, regulatory, medical affairs and safety & pharmacovigilance units all work together to push obeticholic acid as the first approved therapy for the big liver disease.