Amgen to Pay $71M to Settle Off-Label Enbrel, Aranesp Claims
California-based biotech Amgen has agreed to pay $71 million to resolve claims that the company promoted its popular Enbrel and Aranesp drugs for uses not approved by the FDA. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 19, 2015 Category: Pharmaceuticals Source Type: news
Hawaii to receive $800k of $71M settlement with drugmaker Amgen
Hawaii will receive $800,000 as part of a $71 million multi-state settlement with Amgen Inc. over the marketing claims about the drugs Aranesp and Enbrel.
The state will share the settlement with 47 other states and the District of Columbia, officials with the state Department of Commerce and Consumer Affairs’ Office of Consumer Protection said.
The allegations against Amgen Inc. (Nasdaq: AMGN) involve accusations that Amgen promoted Aranesp, which is use to treat anemia, for dosing frequencies… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 19, 2015 Category: American Health Source Type: news
Washington state gets a share of $71M multi-state settlement with Amgen over drug marketing
Oregon Attorney General Ellen Rosenblum took the lead in a multi-state $71 million settlement with drug maker Amgen Inc. in connection with its promotion of two medications.
The settlement resolves allegations that Amgen unlawfully promoted Aranesp and Enbrel. Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel is used to treat plaque psoriasis, among other conditions.
Read the judgment document below.
Specifically, the Complaint and… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 18, 2015 Category: Pharmaceuticals Authors: Elizabeth Hayes Source Type: news
Texas to share in $71M California pharma company settlement
The State of Texas will build up its bank account as a result of Thousand Oaks, California-based Amgen Inc.’s decision to settle a multi-state investigation stemming from allegations it unlawfully promoted biologic medications Aranesp and Enbrel for off-label uses.
Amgen has agreed to pay $71 million to 49 states, including Texas, to resolve the matter, according to Texas Attorney General Ken Paxton. Texas’ share of the settlement is $4.3 million.
Aranesp is a treatment for anemia, and Enbrel… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 18, 2015 Category: Pharmaceuticals Authors: W. Scott Bailey Source Type: news
Amgen Reaches $71 Million Settlement With States
Amgen Inc. reached a $71 million settlement with 48 states related to allegations that the biotechnology company made unsubstantiated marketing claims about blockbuster drugs Aranesp and Enbrel, according to the New York attorney general’s office. (Source: WSJ.com: Health)
Source: WSJ.com: Health - August 18, 2015 Category: Pharmaceuticals Tags: PAID Source Type: news
Enthesitis-Related Arthritis Responds to Enbrel (CME/CE)
(MedPage Today) -- Drug markedly reduced signs and symptoms of juvenile arthritis (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - August 7, 2015 Category: Geriatrics Source Type: news
Amgen raises profit outlook after posting a strong second quarter
Amgen Inc. said strong sales of its rheumatoid arthritis drug Enbrel, osteoporosis drug Prolia, and other treatments, lifted its second-quarter profits and prompted the company to raise its financial forecast for the year.
Thousand Oaks-based Amgen(Nasdaq: AMGN) said its earnings rose to $1.65 billion, or $2.15 per share, from $1.55 billion, or $2.01 per share, a year ago. Income excluding one-time charges was $1.98 billion, or $2.57 per share, 14 cents higher than a prediction by Factset analysts.
Revenue… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 31, 2015 Category: Hospital Management Source Type: news
Amgen raises profit outlook after posting a strong second quarter
Amgen Inc. said strong sales of its rheumatoid arthritis drug Enbrel, osteoporosis drug Prolia, and other treatments, lifted its second-quarter profits and prompted the company to raise its financial forecast for the year.
Thousand Oaks-based Amgen(Nasdaq: AMGN) said its earnings rose to $1.65 billion, or $2.15 per share, from $1.55 billion, or $2.01 per share, a year ago. Income excluding one-time charges was $1.98 billion, or $2.57 per share, 14 cents higher than a prediction by Factset analysts.
Revenue… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 31, 2015 Category: Biotechnology Source Type: news
Severe RA: SB4 Biosimilar as Effective as EtanerceptSevere RA: SB4 Biosimilar as Effective as Etanercept
The biosimilar SB4 was therapeutically equivalent to etanercept in a phase 3 study, but a patent decision may keep it unavailable in the United States until 2028. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 17, 2015 Category: Consumer Health News Tags: Rheumatology News Source Type: news
Etanercept Biosimilar Equivalent in RA (CME/CE)
(MedPage Today) -- Phase III study demonstrates equivalence in efficacy and similarity in safety (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - July 8, 2015 Category: Geriatrics Source Type: news
Samsung’s Bioepis considers Nasdaq IPO, seeks funding
(Reuters) – South Korean Samsung‘s (LON:BC94) Bioepis Co Ltd, a developer of generic versions of biotech drugs, said it was considering a Nasdaq IPO – a move that comes as it seeks about $1.3 billion for product development and as the Samsung Group makes a bigger push into biopharmaceuticals.
Highlighting growth opportunities for its biopharmaceuticals business may be a tactic by the Samsung Group to win support for a planned merger of two affiliates that would strengthen control for its founding Lee family, analysts said.
A proposed $8 billion takeover of construction firm Samsung C&T Corp by the congl...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: MassDevice Tags: Biotech Business/Financial News Wall Street Beat Samsung Bioepis Co Ltd Samsung Electronics Co. Ltd. Source Type: news
WCD: Ixekizumab beats etanercept for psoriatic itch
VANCOUVER, B.C. – Ixekizumab-treated patients with plaque psoriasis reported markedly faster and larger improvements in itch severity than those on high-dose etanercept or placebo in a large head-to-head phase III randomized trial.
Ixekizumab is an investigational humanized IgG4 monoclonal...googletag.display('div-gpt-ad-cta'); (Source: Skin and Allergy News)
Source: Skin and Allergy News - June 27, 2015 Category: Dermatology Tags: SAN Conference News RHEUM Conference News SAN Clinical News SAN News SAN Psoriasis RHEUM News RHEUM Spondyloarthropathies RHEUM Psoriatic arthritis Source Type: news
Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints
Dateline City:
KENILWORTH, N.J. & SEOUL, South Korea
Data Presented for the First Time at the EULAR Annual Meeting
Phase 1 Data for SB2, SB4 and SB5, an Investigational Biosimilar of Humira (Adalimumab), also Presented
KENILWORTH, N.J. & SEOUL, South Korea--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Samsung Bioepis Co., Ltd. today announced that pivotal Phase 3 clinical
studies of SB4, an investigational biosimilar of E...
Source: Merck.com - Research and Development News - June 10, 2015 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news
TNF Inhibition for Alzheimer's Dementia Falls Short TNF Inhibition for Alzheimer's Dementia Falls Short
Weekly subcutaneous etanercept proves safe in AD dementia, with a hint of benefit on psychiatric but not cognitive symptoms in a proof-of-concept phase 2 trial. Further study is planned. Medscape Medical News (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - June 5, 2015 Category: Psychiatry Tags: Neurology & Neurosurgery News Source Type: news
Enbrel Carries Higher Infection Risk in JIA (CME/CE)
(MedPage Today) -- Children with systemic disease more prone to developing medically significant infections (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - May 28, 2015 Category: Geriatrics Source Type: news
