BC Extra | Apr 26, 2019
Company News

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

The Department of Justice said Thursday that Amgen and Astellas have agreed to pay $124.8 million combined to settle allegations of kickbacks to charitable patient assistance programs. Astellas Pharma Inc. (Tokyo:4503) will pay $100 million...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Extra | Feb 22, 2018
Company News

Court sides with FDA in Sensipar exclusivity case

A federal court sided with FDA in a lawsuit in which Amgen Inc. (NASDAQ:AMGN) alleged that the agency had applied standards inconsistently when it denied pediatric exclusivity to Amgen's Sensipar cinacalcet, despite granting the same...
BC Week In Review | Feb 2, 2018
Company News

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

A federal judge ordered FDA to address whether its decision to grant pediatric exclusivity to Ortho Tri-Cyclen norgestimate/ethinyl estradiol from the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) is consistent with its decision...
BC Extra | Feb 2, 2018
Company News

Amgen reports soft 4Q17 earnings, mixed 2018 guidance

Amgen Inc. (NASDAQ:AMGN) reported 4Q17 earnings late Thursday that were below analyst estimates and announced uneven 2018 guidance. The company slipped $3.56 to $182 in after-hours trading. Amgen posted 4Q17 non-GAAP EPS of $2.89 on...
BC Extra | Jan 27, 2018
Company News

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

A federal judge ordered FDA to address whether its decision to grant pediatric exclusivity to Ortho Tri-Cyclen norgestimate/ethinyl estradiol from the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) is consistent with its decision...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Oct 20, 2017
Clinical News

EC approves Amgen's Mimpara for pediatric indication

In August, Amgen Inc. (NASDAQ:AMGN) said the European Commission approved an expanded label for Mimpara cinacalcet (KRN1493, AMG 073) to treat secondary hyperparathyroidism not adequately controlled with standard therapy in patients ages ≥3 with end-stage...
BC Week In Review | 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 include treatment of secondary hyperparathyroidism not adequately controlled with standard therapy in children ages ≥3 with end stage...
BC Week In Review | May 31, 2017
Company News

Amgen suing FDA for Sensipar pediatric exclusivity

In a newly filed lawsuit, Amgen Inc. (NASDAQ:AMGN) is seeking to compel FDA to accept pediatric study reports related to hyperparathyroidism drug Sensipar cinacalcet and extend by six months Amgen's patent exclusivity for the drug....
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