Before she was Foundation Medicine‘s (NSDQ:FMI) chief business executive, Melanie Nallicheri was as an advisor to an ongoing project at the Cleveland Clinic, where she was witness to the power of personalized cancer treatment. Her team was caring for a patient with glioblastoma – an extremely aggressive form of brain cancer with a median survival time […]
Verrica Pharmaceuticals prices $75m IPO to fund drug-device skin therapy
Verrica Pharmaceuticals said this week that it plans to offer 5 million shares priced between $14 to $16 apiece, setting its initial public offering at $75 million. The West Chester, PA-based company expects to use its newly-acquired funds to advance its lead product candidate: a drug-device combination product designed to administer a topical dermatological drug, […]
FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. “The FDA […]
Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon. The newly-approved lengths are designed to treat patients with longer, more complex superficial femoral artery lesions, according to the medtech giant. “As SFA disease progresses, we tend to see patients present with longer, more complex lesions. […]
FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29. The company’s product is a fast-acting therapy based on a novel formulation […]
Medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]
Hospira issues nationwide recall for opioid overdose reversal drug
Pfizer‘s (NYSE:PFE) Hospira unit this week voluntarily recalled two lots of a drug used to reverse the course of an opioid overdose. The company’s naloxone injection, sold in its Carpuject single-use cartridge syringe, was recalled due to the potential presence of embedded and loose particulate matter in the plunger. Hospira specifically warned that products from lots 72680LL and 76510LL […]
FDA clears Insulet’s Omnipod Dash insulin management system
Insulet (NSDQ:PODD) said today that the FDA granted 510(k) clearance to its Omnipod Dash insulin management system. The system wirelessly connects the company’s Personal Diabetes Manager with its tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using blood glucose readings from the Contour Next One blood glucose meter. Altogether, the system […]
FDA’s Gottlieb: Drug shortages are an ‘inevitable consequence of an imperfect system’
When doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left. FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, […]
- 1
- 2
- 3
- …
- 46
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn