The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases. Byooviz (ranibizumab-nuna) is the first biosimilar to Lucentis (ranibizumab injection). It treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment involves an intravitreal injection (delivered into […]
Glaukos announces licensing deal with Attillaps for pharmaceutical compounds
Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Attillaps for its library of pharmaceutical compounds. San Clemente, California-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites — the root cause of Demodex […]
Boston Scientific touts data from Phase 3 study of selective internal radiation therapy
Boston Scientific (NYSE:BSX) today touted data from a Phase 3 clinical trial of its TheraSphere Y-90 glass microspheres treatment. In the trial, the TheraSphere treatment successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) in patients with metastatic colorectal cancer (mCRC) of the liver. Marlborough, Mass.-based Boston Scientific’s TheraSphere treatment, […]
Navidea Biopharmaceuticals makes board of directors changes
Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it made a number of changes on its board of directors. Dublin, Ohio–based Navidea ‘s chair of the board and director S. Kathryn Rouan, along with director Claudine Bruck, retired from those positions, effective immediately. The board appointed Alexander L. Cappello and John K. Scott, Jr., both existing members […]
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. […]
Alfred E. Mann Foundation sells insulin infusion pump IP to Medtronic
The Alfred E. Mann Foundation for Scientific Research (AMF) today announced the sale of intellectual property to Medtronic (NYSE:MDT). As part of the transaction of IP related to implanted infusion pumps, AMF will work with Medtronic to develop the technology into a next-generation implantable insulin pump for people living with hard-to-treat type 1 diabetes in […]
Diabeloop joins corporate advisory partnership, seeks to develop business in U.S.
Diabeloop announced today that it set up a local and dedicated team to support its pursuit of entry into the U.S. market. Paris-based Diabeloop develops an automated insulin delivery (AID) system that deployed throughout Europe this past year, making it commercially available in Germany, the Netherlands, Italy, Spain and Switzerland, with more countries to come. […]
Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic
Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of […]
Philip Morris’ $1.2B offer for inhaled drug delivery tech developer becomes unconditional
Philip Morris (NYSE:PM) announced today that its offer to buy inhaled drug delivery technology developer Vectura has become unconditional. Having received valid acceptances for or acquired 74.77% of Vectura shares, in excess of the 50% required under the acceptance condition, along with confirming that all other conditions to the offer have been satisfied or waived, […]
Oramed hits 50% enrollment in Phase 2 trial for oral insulin capsule
Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it reached over 50% enrollment in a trial for its oral insulin treatment. New York-based Oramed’s Phase 2 trial evaluates its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis (NASH), with patients continuing to be screened at sites in the U.S. and Israel, according to a news […]
