EU039s Tainted-Sartan Ban Praluent Price Cut Metoprolol Shortage Relieved?



European regulators decided to ban any sartan with any level of contamination with probable carcinogenic nitrosamines, but is allowing a 2-year grace period to change manufacturing processes before enforcement. (in-Pharma Technologist.com)

The sartan problem has also reached Japan, FiercePharma reports.

Omron's HeartGuide wearable blood pressure monitor will get software for remote monitoring of patients after discharge for heart failure or heart attack. (MobiHealthNews)

Sanofi and Regeneron said they would cut the list price for alirocumab (Praluent) to $5,850 per year, a 60% reduction, to match that for evolocumab (Repatha) after Amgen slashed that drug's price last October. (Reuters)

Paclitaxel-coated balloons pose little mortality risk in treating superficial femoral artery lesions, according to most (67%) interventionalists polled by CRTonline, with another 23% saying they were unsure. (Trends-in-Medicine Quick Takes)

Most attendees at a paclixtaxel town hall session at the International Symposium on Endovascular Therapy also said they wouldn't change their practice regarding paclitaxel-coated balloons in that setting (69%). (InterventionalNews)

A new generic drug supply chain company's first offering will be metoprolol injections for hypertensive emergencies, a drug which has been in short supply since 2016, parent company Premier announced.

The American College of Chest Physicians updated its guidelines on pulmonary arterial hypertension.

A novel wireless ventricular assist device uses coplanar energy transfer to give patients at least 6 hours of freedom from a holster and batteries has now been used in two patients. (Journal for Heart and Lung Transplantation)

A dime-sized device that turns kinetic energy from the heart into power for implantable cardiac devices was developed from a thin, flexible film that is bio-compatible. (Medical Design & Outsourcing)

Cardiotoxicity from anthracycline chemotherapy might be mitigated by a protein that also boosts anti-cancer effects. (Science Translational Medicine)

All states and the District of Columbia now offer infant screening for critical congenital heart defects, although there's room for improvement with some programs. (Morbidity and Mortality Weekly Report)

A national survey reported in MMWR found more people now know all five common heart attack symptoms (39.6% in 2008 vs 50.2% in 2017) and to call 9-1-1 if someone is having a heart attack (91.8% in 2008 vs 94.9% in 2017).

FDA cleared Cook Medical's Zenith Dissection Endovascular System for use in treating type B aortic dissections and gave premarket approval to the Manta vascular closure device. (Mass Device)

The agency expanded the indication for the Pipeline Flex embolization device from treating large or giant wide-necked intracranial aneurysms to also treat small or medium intracranial aneurysms. (Mass Device)

TELEFLEX's Manta, a vascular closure device, was granted premarket approval.

Smiths Medical/Medex Cardio-Pulmonary issued a class I recall of its sterile saline and sterile water for inhalation due to potential exposure to infectious agents from leaking containers.

The CytoSorb extracorporeal blood purification therapy got the greenlight to continue enrolling patients in the REMOVE trial of endocarditis during valve replacement surgeries and cardiopulmonary bypass procedures. (Mass Device)

Source: https://www.medpagetoday.com/cardiology/prevention/77940

Praluent not worth the price, finds study - Pharmaphorum



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Beginning July 1, doctors can submit just one form white House Says Its Health Plan Actions Are Saving Taxpayer attesting that a patient with heart disease meets criteria for pcsk9 therapy, such as inability to sufficiently lower LDL with cheap statins, like generic versions of Pfizers Lipitor. VelocImmune technology that yields optimized fully-human antibodies, and is being jointly developed and commercialized by Sanofi and Regeneron under a global collaboration agreement. For alirocumab users, this should change with todays agreement. This is a significant simplification compared to many current utilization management processes that involve multiple steps and lengthy documentation, including submitting laboratory results and detailed patient histories. But the addition of ezetimibe cost 81 000 per qaly compared with a statin alone. This is the first agreement since Sanofi and Regeneron announced in March 2018 that they would lower the net price of Praluent for payers willing to reduce access barriers for appropriate patients.