Harbour BioMed acquired the rights to Sichuan Kelun-Biotech Biopharmaceutical's anti-PD-L1 antibody A167 outside of greater China. The deal gives Kelun-Biotech up to $350 million from upfront and milestone payments, plus royalties.
Aravive Biologics' AVB-S6-500, being developed to treat patients with platinum-resistant recurrent ovarian cancer, received fast-track designation from the FDA. An early-stage trial of the candidate demonstrated favorable safety with no serious adverse events in healthy volunteers.
The European Medicines Agency granted Pfizer's lorlatinib promising innovative medicine status. Lorlatinib is currently under review for patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer who have already received a second-generation ALK tyrosine kinase inhibitor.
An initial public offering has been filed by Principia Biopharma, which aims to raise up to $86.3 million to bring its lead candidate, PRN1008 -- a Bruton's tyrosine kinase inhibitor being evaluated in midstage trials for pemphigus, an autoimmune skin disease, as well as the bleeding disorder immune thrombocytopenic purpura -- into late-stage testing.
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China's State Drug Administration granted approval to Roche Holding's Alecensa, or alectinib, as monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. In a late-stage trial, the drug achieved the primary endpoint of improving progression-free survival compared with Xalkori, or crizotinib, and the results helped alectinib get approved.
The government of India launched an 18-month experimental project of biotech mosquitoes to control the spread of dengue fever. Aedes aegypti mosquitoes will be infected with Wolbachia bacteria, then released into the wild to mate with local mosquitoes and spread the bacteria, which suppresses the transmission of other blood-borne diseases by infected mosquitoes.
Over 290,000 comments were filed regarding the Environmental Protection Agency's proposed rule for 2019 renewable volume obligations and 2020 RVO for biomass-based diesel under the under the Renewable Fuel Standard. The proposed rule would require 19.88 billion gallons of biofuel to be added into the country's fuel supply next year and would set the 2020 RVO for biomass-based diesel at 2.43 billion gallons.
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