Mylan (NSDQ:MYL) today launched its bivalirudin injection in the U.S. as a generic version of The Medicines Co.‘s (NSDQ:MDCO) Angiomax product. The medicine is a direct thrombin inhibitor designed as an anticoagulant. Mylan’s bivalirudin single-dose vial was approved by the FDA for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. The product is also indicated […]
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 […]
HealthPrize takes aim at medication nonadherence with habit-forming tech
At HealthPrize Technologies, chief executive Tom Kottler is tackling a problem that many in the pharmaceutical industry are trying to solve: What stops people from taking their medications and how can the industry boost medication adherence rates? In order to encourage patient compliance, Kottler told Drug Delivery Business News that he’s taking a different approach than his […]
Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis. In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan‘s (NSDQ:MYL) EpiPen auto-injector. “Because epinephrine is […]
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 […]
Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva. Pulmatrix used salt-based excipients and spray-drying techniques as part of its iSperse drug-delivery platform to […]
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 […]
Noble launches AdhereIT platform for self-injection training
Noble this week launched its connected device platform, AdhereIT, to provide people that use auto-injectors with real-time feedback regarding their injection. Users can attach the AdhereIT system to an auto-injector training device or a commercial product, Noble reported. The platform can detect when the auto-injector makes contact with a user’s skin and the time when an […]
- 1
- 2
- 3
- …
- 133
- Next Page »
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn