MannKind today announced six-month results from its Phase 3 INHALE-1 study of Afrezza insulin inhalation powder in children. INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to […]
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MannKind has more positive inhaled insulin data
MannKind announced top-level 30-week results from its Phase 4 INHALE-3 study comparing inhaled insulin to traditional delivery methods. 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 looks at Afrezza against usual care. Mannkind defines usual care as multiple […]
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 […]
MannKind inks $61m direct offering of common stock
MannKind (NSDQ:MNKD) said today that it inked a deal with a group of unnamed investors for a registered direct offering of 10,166,600 shares of the company’s common stock for $6.00 apiece. The $61 million offering is slated to close later this week. “With this offering, we have made substantial progress in our efforts to recapitalize […]
MannKind posts mixed Q2
Shares in MannKind Corp. (NSDQ:MNKD) fell slightly this morning after the biopharmaceutical company missed earnings expectations but beat sales estimates on Wall Street with its second quarter results. The Valencia, Calif.-based company posted a net loss of -$35.4 million on sales of $2.2 million for the 3 months ended June 30, for bottom-line loss of -18% on […]
MannKind combines inhaled insulin with One Drop’s digital diabetes tech
MannKind Corp. (NSDQ:MNKD) and One Drop said today that the group launched its A-One trial evaluating MannKind’s inhaled insulin, Afrezza, for use with One Drop’s digital diabetes management platform. The companies reported that they are enrolling people with Type II diabetes and randomizing them in two treatment arms. One group of patients will use Afrezza with […]
Anika names medtech veteran as new president | Personnel Moves – July 31, 2017
Anika Therapeutics (NSDQ:ANIK) last week named medtech veteran Joseph Darling as president, taking over the role from CEO Charles Sherwood. The chief exec plans to stay in the corner office as he transitions the role of president to Darling. Previously, Darling worked as an executive in privately-held orthopedic companies. He has also held senior level executive […]
Milestone Scientific appoints new CEO following FDA nod | Personnel Moves – July 13, 2017
Milestone Scientific (NYSE:MLSS) said this week that it appointed Daniel Goldberger to the company’s corner office. Leonard Osser, who previously served as CEO, is slated to remain on the board and will continue to serve as director of Milestone’s China operations. The appointment comes on the heels of the FDA’s decision to grant Milestone’s CompuFlo epidural […]
MannKind inks deal to bring inhaled insulin to Brazil
MannKind Corp. (NSDQ:MNKD) said today that the company inked a supply and distribution deal with Biomm for the commercialization of its inhaled insulin, Afrezza, in Brazil. According to the agreement, Biomm will prepare and file the necessary applications for regulatory approval. MannKind will be responsible for manufacturing and supplying Afrezza and Biomm is slated to […]