Pharminent

Amgen’s cholesterol drug shows positive effect in cardiovascular outcomes study

Amgen’s cholesterol drug Repatha (evolocumab) has showed positive effect in a 27,564-patient cardiovascular outcomes study. http://clinicaltrials.pharmaceutical-business-review.com/news/amgens-cholesterol-drug-shows-positive-effect-in-cardiovascular-outcomes-study-200317-5766473

Filed under: Cardiovascular, PCSK9

Amgen Keeps Cholesterol Drug Patent vs. Regeneron

http://www.investopedia.com/news/amgen-keeps-patent-vs-regeneron-sanofi-amgn-regn/

Filed under: Cardiovascular, PCSK9

Amgen Announces Positive Top-Line Results From Phase 3 GLAGOV Imaging Study Of Repatha® (Evolocumab)

THOUSAND OAKS, Calif., Sept. 20, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Phase 3 GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) trial evaluating the effect of Repatha® (evolocumab) on… http://www.prnewswire.com/news-releases/amgen-announces-positive-top-line-results-from-phase-3-glagov-imaging-study-of-repatha-evolocumab-300330644.html

Filed under: Cardiovascular, PCSK9

FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor

THOUSAND OAKS, Calif., July 11, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose… http://www.prnewswire.com/news-releases/fda-approves-first-and-only-single-monthly-injection-for-a-pcsk9-inhibitor-300296280.html

Filed under: Cardiovascular, PCSK9

CardioBrief: First PCSK9 Outcome Trial Results Pushed Back To 2017

(MedPage Today) — Uptake of the new drugs likely to lag a little longer http://www.medpagetoday.com/Cardiology/CardioBrief/58400

Filed under: Cardiovascular, PCSK9

Sanofi, Amgen cholesterol drugs win UK backing after price cuts

[Reuters] – Two rival cholesterol-lowering injections from Sanofi and Amgen have been recommended by Britain’s healthcare cost watchdog after the manufacturers offered special discounts to the country’s state-run health service. Sanofi’s Praluent, which was developed with Regeneron , and Amgen’s Repatha are both so-called PCSK9 medicines that work in a different way to existing cholesterol fighters such as statins. The National Institute for Health and Care Excellence (NICE) said in draft guidance on Friday that both drugs could be considered for use by people whose cholesterol is still not under control despite trying other treatments. http://us.rd.yahoo.com/finance/news/rss/story/*http://finance.yahoo.com/news/sanofi-amgen-cholesterol-drugs-win-230101015.html

Filed under: Cardiovascular, PCSK9

Pfizer’s PCSK9 inhibitor clears another phase III trial

Bococizumab will compete with Praluent and Repatha if it
reaches the market http://www.pmlive.com/pharma_news/pfizers_pcsk9_inhibitor_clears_another_phase_iii_trial_969082

Filed under: Cardiovascular, PCSK9

AMCP Partnership Forum on Cholesterol Management Urges Use of Proven Therapies and Developing Management Strategies for PCSK9 Inhibitors

ALEXANDRIA, Va., March 30, 2016 /PRNewswire-USNewswire/ — Patients with high cholesterol should use proven and less expensive therapies, such as statins, before trying the new and more expensive class of specialty cholesterol drugs known as PCSK9 inhibitors, according to recommendations… http://www.prnewswire.com/news-releases/amcp-partnership-forum-on-cholesterol-management-urges-use-of-proven-therapies-and-developing-management-strategies-for-pcsk9-inhibitors-300243546.html

Filed under: Cardiovascular, PCSK9

First round to Amgen in PCSK9 patent battle with Sanofi, Regeneron

US court concludes Praluent has infringed rival
cholesterol drug Repatha http://www.pmlive.com/pharma_news/first_round_to_amgen_in_pcsk9_patent_battle_with_sanofi,_regeneron_956823

Filed under: Cardiovascular, PCSK9

NICE says ‘no’ to alirocumab in draft guidance

NICE says ‘no’ to alirocumab in draft guidance

Filed under: Cardiovascular, PCSK9

Amgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End Points

Teasing with top-line results, the company says the PCSK9 inhibitor dropped LDL-C vs ezetimibe at 24 weeks in patients intolerant of statins, similar to what was shown in the 12-week GAUSS-2 trial. Heartwire from Medscape http://www.medscape.com/viewarticle/858462?src=rss

Filed under: Cardiovascular, PCSK9

Amgen’s Repatha® (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol

[PR Newswire] – THOUSAND OAKS, Calif., Jan. 21, 2016 /PRNewswire/ — Amgen (AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha® (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1 Repatha was developed in Japan by Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo. In Japan, Repatha is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins). http://finance.yahoo.com/news/amgens-repatha-evolocumab-approved-first-060000979.html

Filed under: Cardiovascular, PCSK9

CardioBrief: First PCSK9 Drug Outcomes Trial Due in 2016

(MedPage Today) — FOURIER set to finish ahead of schedule http://www.medpagetoday.com/Cardiology/CardioBrief/55379

Filed under: Cardiovascular, PCSK9

Therapeutic Focus 2016: Cardiovascular

http://www.mmm-online.com/therapeutic-focus/therapeutic-focus-2016-cardiovascular/article/460650/

Filed under: Cardiovascular, PCSK9

Amgen PCSK-9 Prescription Volumes Ahead of Regeneron Pharmaceuticals

http://www.bidnessetc.com/59599-amgen-pcsk9-prescription-volumes-ahead-of-regeneron-pharmaceuticals/

Filed under: Cardiovascular, PCSK9

The new PCSK9 scorecard: Praluent favored by UnitedHealth, Repatha by CVS, both by Express Scripts

The nation’s largest private health insurer announced on Friday that the Sanofi/Regeneron cholesterol-lowering med would be the preferred option of its PBM, guaranteeing an intense marketing battle between the companies and rival Amgen. http://www.biopharmadive.com/news/the-new-pcsk9-scorecard-praluent-favored-by-unitedhealth-repatha-by-cvs/410161/

Filed under: Cardiovascular, PCSK9

Sanofi and Regeneron Announce UnitedHealth Group Selects Praluent® (alirocumab) Injection for Preferred Access

[PR Newswire] – BRIDGEWATER, N.J. and TARRYTOWN, N.Y., Dec. 11, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. today announced that UnitedHealth Group will provide preferred access to Praluent® (alirocumab) Injection through OptumRx and UnitedHealthcare for Commercial, Medicare, and Managed Medicaid patients. Praluent is the only PCSK9 inhibitor preferred across UnitedHealth Group formularies. Praluent is the only PCSK9 inhibitor currently available in two doses, that allows a healthcare provider to adjust the dose based on their patient’s LDL cholesterol lowering needs. http://us.rd.yahoo.com/finance/news/rss/story/*http://finance.yahoo.com/news/sanofi-regeneron-announce-unitedhealth-group-060000671.html

Filed under: Cardiovascular, PCSK9

PCSK9 formulary wars rage on as Sanofi’s Praluent nabs UnitedHealth advantage

But if the therapy doesn’t work after 12 weeks, patients covered by the insurer’s Oxford PBM unit can switch to Amgen’s competing Repatha (evolocumab).  http://www.biopharmadive.com/news/pcsk9-formulary-wars-rage-on-as-sanofis-praluent-nabs-unitedhealth-advanta/410161/

Filed under: Cardiovascular, PCSK9

Why UnitedHealth Group Unit Prefers Regeneron Pharmaceuticals Drug Over Amgen

On the other hand, Repatha comes in a single-dose option and needs to be administered once a month. “Praluent is the only PCSK9 inhibitor currently available in two doses, providing physicians with the flexibility to tailor therapy to individual patients …
http://www.bidnessetc.com/58456-why-unitedhealth-unh-unit-prefers-regenerons-drug-over-amgens-amgn/

Filed under: Cardiovascular, PCSK9

Repatha Vs. Praluent: Will Amgen’s Patents Decide The Race For The Prevailing PCSK9 Inhibitor?

http://seekingalpha.com/article/3724596-repatha-vs-praluent-will-amgens-patents-decide-the-race-for-the-prevailing-pcsk9-inhibitor

Filed under: Cardiovascular, PCSK9

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