Theravance Biopharma Inc. inked a definitive agreement with Royalty Pharma potentially worth more than $1.5 billion to sell through a subsidiary, Theravance Respiratory Co. LLC, its 85% interest in royalty rights to Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, GSK plc), a once-daily, single-inhaler triple therapy for chronic obstructive pulmonary disease and asthma. Read More
The data safety monitoring board overseeing Contrafect Corp.’s phase III study of exebacase, a hydrolase stimulator for treating Staphylococcus aureus bacteremia, recommended the study be stopped. In an interim analysis, the board said the conditional power of the study was below the prespecified threshold for futility. Read More
Precision Autoimmune Therapeutics Co. Ltd. has raised ¥140 million (US$21 million) in its first financing round to speed up its pipeline development and improve its drug development platform. Emerging Technology Partners LLC, Redhill Capital and CASI Pharmaceuticals Inc. participated in the round. Read More
Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market. Read More
European regulators have added several safety messages to approved COVID-19 vaccines, including a warning that Novavax Inc.’s Nuvaxovid could produce severe allergic reactions. Read More
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said. Read More
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates. Read More
As a last-ditch effort to preserve skinny labeling for generics, Teva Pharmaceuticals USA Inc. is asking the U.S. Supreme Court to review a Federal Circuit split opinion in Glaxosmithkline plc v. Teva Pharmaceuticals that upset the status quo of the generic marketplace. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atara, Bio-Thera, Endevica, Evolus, Glenmark, Humanigen, Hutchmed, Optinose, Pluristem, Rhythm, Sanotize, Vaxcyte, Xortx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Act, Adipopharma, Altamira, Anthos, Bicycle, Coagulant, Comera, Currax, Epicentrx, Genscript, Hemab, Hoth, Immunoprecise, Intron, Mymd, Nilogen, Novo Nordisk, Relief, Renovacor, Roche, Siga, SQZ, Swedish Orphan, Teva, Turn, Vivus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Avrobio, Immedica, Neoimmunetech, Orthox, Provepharm, Rznomics, SK. Read More
