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llllllllll omaveloxolone (RTA 408) / AbbVie, ReataReata Pharmaceuticals, Inc. Announces Second Quarter 2020 Financial Results and Provides an Update on Business Operations and Clinical Development Programs (GlobeNewswire) - Aug 10, 2020 - "We recently completed a Type C meeting in which the FDA provided us with guidance that it does not have any concerns with the reliability of the mFARS primary endpoint results in the MOXIe Part 2 study. Nevertheless, the FDA is not convinced that the MOXIe Part 2 results...At the Type C meeting, to address the FDA’s requirement, FARA, key opinion leaders, and Reata proposed a second study (the 'crossover study') to provide additional evidence of effectiveness....If the FDA accepts this approach, we expect to complete the crossover study as early as the fourth quarter of this year. Assuming that the FDA views the crossover study data as sufficiently positive to provide confirmatory evidence, our plan would be to submit an NDA during the first quarter of 2021." llllllllll lenzilumab (KB003) / HumanigenHumanigen Expands Phase III Study of Lenzilumab in COVID-19 to Brazil (Businesswire) - Aug 10, 2020 - "Humanigen...announced that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil. This study, now set to begin recruiting patients in Brazil..." llllllllll Copiktra (duvelisib) / VerastemVerastem Oncology Signs Definitive Agreement to Sell COPIKTRA (duvelisib) Rights to Secura Bio to Focus on Development of VS-6766 and Defactinib in KRAS Mutant Solid Tumors (Businesswire) - Aug 10, 2020 - "Verastem, Inc...announced that it has entered into a definitive agreement to sell its global commercial and development rights to COPIKTRA (duvelisib), its marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc., an integrated biopharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies....Upon closing of the transaction with Secura Bio, Verastem will be dedicated to the development of this program and to deliver on clinical and regulatory milestones for the first potential indications in low-grade serous ovarian cancer (LGSOC) and KRASmt non-small cell lung cancer (NSCLC)." llllllllll Olinvyk (oliceridine) / Trevena, Jiangsu NHWA PharmaTrevena Announces FDA Approval of OLINVYK (oliceridine) injection (GlobeNewswire) - Aug 10, 2020 - "The Company expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the DEA, which may take up to 90 days. The Company is committed to an ethical and responsible marketing campaign for OLINVYK and will have safeguards in place to monitor for and mitigate the risk of non-medical uses of OLINVYK. The Company also today announced $54.8 million in cash and cash equivalents as of June 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2021." llllllllll surufatinib (HMPL-012) / Chi-MedChi-Med Plans to Submit Marketing Authorization Application for Surufatinib Following Scientific Advice from EMA’s CHMP (GlobeNewswire) - Aug 10, 2020 - "Hutchison China MediTech Limited...today announces that it received scientific advice from the European Medicines Agency's ('EMA') Committee for Medicinal Products for Human Use ('CHMP') for surufatinib for the treatment of patients with advanced neuroendocrine tumors ('NET'). Based on the CHMP advice, we have concluded that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a marketing authorization application ('MAA'). Given that no filing issues were identified, the MAA submission is planned for 2021..."
