Novo Nordisk announced that the FDA issued a Complete Response Letter (CRL) related to its once-weekly insulin submission. In the CRL, the FDA made requests for Novo Nordisk to complete before it can complete its review of a Biologics License Application (BLA). As a result, the insulin maker said it does not expect to fulfill […]
Pharmaceuticals
Roche, Genentech to reintroduce drug-eluting eye implant in U.S. following 2022 recall
Roche subsidiary Genentech today reintroduced its Susvimo therapy for delivery via ocular implant in the U.S. following a recall. The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. […]
Biora Therapeutics has positive oral drug delivery device data for treating ulcerative colitis
Biora Therapeutics shared positive topline results from a trial of its orally administered drug-device combination for treating ulcerative colitis (UC). BT-600, a proprietary liquid formulation of tofacitinib, is delivered directly to the colon using Biora’s ingestible NaviCap device. Biora designed NaviCap to improve patient outcomes by enabling therapeutic delivery directly to the site of the […]
Koru Medical gets regulatory nod in Japan for FreedomEdge drug delivery system
Koru Medical Systems (Nasdaq:KRMD) announced today that it received regulatory clearance in Japan for its FreedomEdge infusion system. Clearance covers the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH). FreedomEdge offers the convenient and efficient administration of large-volume subcutaneous therapies at […]
The biggest stories from the American Diabetes Association (ADA) 2024 Scientific Sessions
The American Diabetes Association took to Orlando, Florida, the past few days for its 84th Scientific Sessions as optimism grows over diabetes tech. Topics covered included expanding technologies to the type 2 diabetes population (90% of people with diabetes), GLP-1 drugs, automation, broadening user bases and more. The usual big-hitters stepped up to the plate […]
MannKind’s inhaled insulin meets primary efficacy endpoint in study
MannKind today announced positive 17-week results from a Phase 4 U.S. clinical study of its Afrezza inhaled insulin powder. The Danbury, Connecticut-based company designed Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with type 1 diabetes mellitus. The INHALE-3 study evaluated Afrezza against usual care — defined as multiple daily injections […]
Ypsomed inks autoinjector deal with German pharma company Medac
Ypsomed announced that German company Medac selected its autoinjector technology for the relaunch of its methotrexate pen. The YpsoMate 1.0 will gradually replace the current available metoject/metex pen for the German company’s methotrexate products. Ypsomed launched its new autoinjector in various countries during the first quarter of this year. Medac develops subcutaneous methotrexate (MTX) products, […]
Vaccine patch maker Vaxess raises $12M, names new CEO
Shelf-stable vaccine patch maker Vaxess Technologies announced today that it raised $12 million and appointed Rachel Sha as its new CEO. This round brings the company’s total funding to more than $90 million after it raised $9 million last September as well. Investors included RA Capital Management, Engine Ventures, GHIC and Mission Bio Capital. Cambridge, […]
Enable Injections inks deal to develop Parkinson’s therapy for delivery with EnFuse
Enable Injections announced today that it partnered with Serina Therapeutics to develop therapeutics for the enFuse delivery system. The companies aim to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse to treat Parkinson’s disease. This deal builds upon a recent agreement that allows Roche to obtain a worldwide, exclusive license to develop and commercialize […]
Carthera wins U.S., EU orphan drug designation for SonoCloud
Carthera announced today that it received FDA and European orphan drug designation (ODD) for the use of carboplatin with its SonoCloud. The designation allows Paris, France-based Carthera to use carboplatin chemotherapy in the treatment of malignant glioma. Carthera conducts this treatment through the use of SonoCloud, a device that emits ultrasound to temporarily increase the […]
