- FDA Clears 2 New Propeller Health Devices That Track Respiratory Meds (xconomy.com)
Propeller Health has received FDA clearance to sell two new devices to help chronic respiratory disease patients track their medication usage and better follow their recommended treatment regimens...individualized feedback for patients and their caregivers..
- WHO prequalification for Novartis’ malaria drug Coartem (pharmatimes.com)
Novartis’ high-dose malaria medicine Coartem has received World Health Organization prequalification, potentially paving the way for as many as 25 million patients in Africa to access to the drug.
- FDA Grants Expanded Access to Multiple Myeloma Drug (specialtypharmacytimes.com)
Access is open to US adult patients who are refractory to the most common anti-myeloma drug classes. Multiple myeloma patients in immediate need of new treatment options can receive Janssen’s investigational daratumumab through an expanded access program.
- New and Generic Drug Approvals June 17, 2015 (fda.gov)
- Two therapies win NICE favour for diabetic sight condition (pharmatimes.com)
Two very different eye treatments have won backing from the National Institute for Health and Care Excellence for...diabetic macular oedema, paving the way for their use by the National Health Service (United Kindom)...Eylea (aflibercept) and implant Ozurdex (dexamethasone)
- NHS Scotland approves funding for five new drugs (biopharmadive.com)
- Nexavar - approved for differentiated thyroid carcinoma
- Adempas - treat pulmonary arterial hypertension
- Entyvio - treatment of moderate-to-severe Crohn's disease
- Innohep - treatment of venous thrombo-embolism
- Zevtera - treatment of hospital-acquired pneumonia
- Novartis Heart Failure Drug Gains Speedy FDA Approval (forbes.com)
Entresto, Novartis’s novel heart failure drug, gained FDA approval earlier today...approval arrived 6 weeks ahead of the drug’s action date...the drug had already received a fast track designation and an expedited review under the FDA’s priority review program.
- Amgen Wins EU Approval to Be First in New Cholesterol Drug Class (bloomberg.com)PCSK9 inhibitor evolocumab gets green light for European approval (pharmaceutical-journal.com)
Amgen Inc. won approval in the European Union for its drug Repatha, the first regulatory clearance for a new class of powerful cholesterol-lowering drugs… for patients with uncontrolled cholesterol who require additional intensive reduction of low density lipoprotein...
- EU approves BMS’ once-daily HIV combo pill (pharmatimes.com)
European regulators have approved Bristol-Myers Squibb’s Evotaz for the treatment of … HIV-1…once-daily therapy combines atazanavir,.. and cobicistat,.. there are 2.2 million HIV-infected individuals in the E.U. …those who are not resistant to protease inhibitors, Evotaz represents an important new treatment option that may help them attain and retain virologic suppression.
- FDA approves Medicines Co’s blood clot drug after a decade (newsdaily.com)
Food and Drug Administration …Medicines Co’s blood clot preventer Cangrelor (Kengreal), which has faced multiple setbacks since it first entered late-stage studies close to a decade back...funneled about $200 million into developing Cangrelor over the past decade, which included two unsuccessful trials and a pivotal study last year that drew scathing criticism as well as a rejection from the FDA.