BioCentury | Oct 1, 2020
Politics, Policy & Law

House committee targets Mallinckrodt, Amgen and Novartis over price increases

...approved in 1952; Enbrel etanercept and Sensipar cinacalcet...
BioCentury | Apr 26, 2019
Company News

Amgen, Astellas join list of biopharmas paying for alleged co-pay charity kickbacks

...Xtandi enzalutamide, and Amgen Inc. (NASDAQ:AMGN) will pay $24.75 million related to funds for Sensipar cinacalcet...
BioCentury | Jan 5, 2019
Finance

Ready to launch

.../ Sanofi (Euronext:SAN; NYSE:SNY) Aubagio teriflunomide $1,880.9 $1,393.8 $1,858.3 -1% Amgen Inc. (NASDAQ:AMGN) Sensipar cinacalcet (Mimpara...
BioCentury | Feb 22, 2018
Company News

Court sides with FDA in Sensipar exclusivity case

...that the agency had applied standards inconsistently when it denied pediatric exclusivity to Amgen's Sensipar cinacalcet...
...for why it granted pediatric exclusivity to Ortho Tri-Cyclen norgestimate/ethinyl estradiol from J&J, but not Sensipar...
...the exclusivity. Amgen sought to compel the agency to accept Amgen's pediatric study reports for Sensipar...
BioCentury | Feb 2, 2018
Company News

FDA to review its pediatric exclusivity decision for Amgen's Sensipar

...& Johnson (NYSE:JNJ) is consistent with its decision to deny the same exclusivity to Sensipar cinacalcet...
...the agency to accept Amgen's pediatric study reports and grant pediatric exclusivity for hyperparathyroidism drug Sensipar...
...in the case, including Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). Amgen said a key Sensipar...
BioCentury | Feb 2, 2018
Company News

Amgen reports soft 4Q17 earnings, mixed 2018 guidance

...of Amgen's $21.8-$22.8 billion range coming in below the $22.9 billion consensus. Hyperparathyroidism drug Sensipar cinacalcet...
...Johnson & Johnson (NYSE:JNJ) is consistent with its decision to deny the same exclusivity to Sensipar...
BioCentury | Jan 27, 2018
Company News

FDA to review its pediatric exclusivity decision for Amgen's Sensipar

...& Johnson (NYSE:JNJ) is consistent with its decision to deny the same exclusivity to Sensipar cinacalcet...
...the agency to accept Amgen's pediatric study reports and grant pediatric exclusivity for hyperparathyroidism drug Sensipar...
...in the case, including Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). Amgen said a key Sensipar...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...Gilead Sciences Inc. (NASDAQ:GILD) Atripla efavirenz/emtricitabine/tenofovir $2,605.0 $1,366.0 $1,821.3 -30% Amgen Inc. (NASDAQ:AMGN) Sensipar cinacalcet (Mimpara...
BioCentury | Oct 20, 2017
Clinical News

EC approves Amgen's Mimpara for pediatric indication

...Amgen Inc. (NASDAQ:AMGN) said the European Commission approved an expanded label for Mimpara cinacalcet (KRN1493, AMG 073...
...as Sensipar in the U.S. and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) markets it as Regpara...
...LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Mimpara cinacalcet ( Regpara , Sensipar) (KRN1493, AMG 073) Business: Endocrine/Metabolic Mary Romeo AMG 073 KRN1493 Mimpara Regpara Sensipar Amgen...
BioCentury | Jul 7, 2017
Clinical News

EMA's CHMP recommends pediatric label expansion for Amgen's Mimpara

...EMA’s CHMP recommended a label expansion for Mimpara cinacalcet (KRN1493, AMG 073) from Amgen Inc. (NASDAQ:AMGN) to...
...as Sensipar in the U.S. and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) markets it as Regpara...
...LSE:SHP; NASDAQ:SHPG) Product: Mimpara cinacalcet ( Regpara , Sensipar) ( KRN1493 , AMG 073) Business: Endocrine/Metabolic Alex Himes cinacalcet Mimpara Amgen...
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