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 […]
Foundation Medicine looks to expand oncology arsenal with precision drugs
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 […]
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. […]
Sirtex accepts CDH acquisition offer, moves away from Varian
In the ongoing back-and-forth to acquire Sirtex Medical (ASX:SRX), it seems that Varian Medical‘s (NYSE:VAR) $1.2 billion bid just wasn’t enough. Varian said today that it heard from Sirtex that the company’s board couldn’t turn down the $1.41 billion unsolicited offer from China’s CDH Investments. The bid from CDH Investments came in at a 20% premium […]
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 […]
Johnson & Johnson OKs $2B LifeScan sale to Platinum Equity
Johnson & Johnson (NYSE:JNJ) said today that it accepted a binding offer of more than $2 billion from private equity shop Platinum Equity for its LifeScan blood glucose monitoring business as it moves toward the exit in the diabetes market. The New Brunswick, N.J.-based healthcare conglomerate early last year announced a strategic review of its LifeScan, […]
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