Seattle Genetics (NSDQ:SGEN) said today that the FDA granted Breakthrough Therapy Designation to its antibody-drug conjugate Adcetris in combination with chemotherapy for treating patients with advanced classical Hodgkin lymphoma. The approval was based on positive top line results from the company’s phase 3 Echelon-1 clinical trial, which were announced in June. The Bothell, Wash.-based company said […]
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J&J’s Janssen wins $45m BARDA contract for Ebola vaccine dev
Johnson & Johnson (NYSE:JNJ) said today that its Janssen Pharmaceutical subsidiary Janssen Vaccines & Prevention B.V received a $44.7 million award and collaborative partnership from the US Biomedical Advanced Research and Development Authority to support its development of an investigational Ebola vaccine regimen. The deal comes with an option for BARDA to provide additional funding over 5 […]
Abbott’s $5B acquisition of Alere set to close tomorrow
Abbott (NYSE:ABT) said today it is looking to close its $5 billion acquisition of Alere (NYSE:ALR) tomorrow, saying it has received all regulatory clearances necessary. The Abbott Park, Ill.-based company said the acquisition will establish it as a “global leader in point of care testing,” which it sees as the fastest growing segment of the $50 billion in vitro […]
Novo Nordisk wins FDA nod for fast-acting mealtime insulin
Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection. The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported. The […]
Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem
Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use […]
Insulet “bets big” on Massachusetts with new manufacturing facility in Acton
Insulet (NSDQ:PODD) broke ground at its new manufacturing facility in Acton, Mass. yesterday, hosting a ceremony that featured the state’s governor, Charlie Baker, members of Baker’s administration and a young “Podder” named Lexi Bentinganan. Diagnosed at age 7 with Type I diabetes, Lexi has been using Insulet’s tubeless insulin delivery device, the Omnipod, since 2013. “It […]
Cogentix backs Vensica Medical and its needle-free drug delivery system
Cogentix Medical (NASDAQ: CGNT) said today that it invested $2 million in privately-held Vensica Medical and its ultrasound-based, needle-free drug delivery device, VensiCare. Israel-based Vensica Medical is developing its VensiCare device as a way to deliver botulinum toxin to treat overactive bladder. The company also has IP for the delivery of oncology agents to the […]
Avita Medical submits PMA app for ReCell burn injury treatment
Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device. The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments. The PMA application is supported by clinical data from two trials. The […]
Tandem touts adoption of CGM update to t:slim X2 insulin pump
Last month, Tandem Diabetes Care (NSDQ:TNDM) announced that the FDA approved its t:slim X2 insulin pump integrated with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The San Diego, Calif.-based company made the software available to its current t:slim X2 pump users at no additional cost, enabling them to add CGM-integration to their existing devices. Today, the company reported […]
SteadyMed requests meeting with FDA over rejected application for drug-device combo
Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the […]