Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
Genentech Inc. didn’t need to wait until Thanksgiving for the U.S. FDA to make up its mind. More than a month ahead of its PDUFA date, the agency approved the firm’s first-line breast cancer treatment, Itovebi (inavolisib), providing the oral therapy a place with other niched therapies from Astrazeneca plc and Novartis AG. Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and Faslodex (fulvestrant, Astrazeneca) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
Novartis AG is enlisting the help of Generate:Biomedicines Inc. and its artificial intelligence platform to generate drugs for multiple undisclosed targets. The number of targets and therapeutic areas also weren’t disclosed. Novartis will pick the targets, although the targets Generate has been working on are off limits. Generate will be responsible for creating the lead candidate, at which point Novartis will take over development.
The risk and benefit of Pfizer Inc.’s oral sickle cell disease drug Oxbryta (voxelotor) has flipped, prompted by what the company called new clinical data indicating “an imbalance in vaso-occlusive crises and fatal events” that need more study. Based on an EMA recommendation, Pfizer said it is voluntarily recalling all lots of Oxbryta from wherever it’s approved worldwide. Pfizer also is shuttering its Oxbryta clinical studies and expanded access programs.
Novartis AG is enlisting the help of Generate:Biomedicines Inc. and its artificial intelligence platform to generate drugs for multiple undisclosed targets. The number of targets and therapeutic areas also weren’t disclosed. Novartis will pick the targets, although the targets Generate has been working on are off limits. Generate will be responsible for creating the lead candidate, at which point Novartis will take over development.
The increasing resistance to intravenous artemisinin therapy for malaria highlights the urgent need for new treatments that offer better patient compliance and a single-dose cure to address this global health threat. Novartis AG recently presented the discovery, development and evaluation of aminoisoquinolines as fast-acting intravenous therapeutic agents for severe malaria treatment.
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
Novartis AG described the identification and activity of TAK-756, a novel, selective and potent TAK1 inhibitor, as a potential intra-articular therapy for the treatment of osteoarthritis. Previous studies demonstrated that TAK1 appears to be a potential target for controlling inflammation and catabolism through NF-κB and MAPK pathways.
Siemens Healthineers AG made a binding offer to Novartis AG, of Basel, Switzerland, to acquire its Advanced Accelerator Applications Molecular Imaging business which includes the European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography scans.
