FDA OK's Novartis Biosimilar to Amgen Arthritis Drug, Enbrel
Sandoz, a division of Novartis, announces FDA approves Erelzi to treat multiple inflammatory diseases (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 30, 2016 Category: Pharmaceuticals Source Type: news
FDA OKs Biosimilar to Etanercept for Inflammatory Diseases FDA OKs Biosimilar to Etanercept for Inflammatory Diseases
Erelzi, a biosimilar to Enbrel, treats rheumatoid arthritis, among other disorders. It comes with a boxed warning about the risk for serious infections such as tuberculosis.FDA Approvals (Source: Medscape Pediatrics Headlines)
Source: Medscape Pediatrics Headlines - August 30, 2016 Category: Pediatrics Tags: Rheumatology News Alert Source Type: news
FDA approves Novartis biosimilar to Amgen's Enbrel
WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Novartis AG's biosimilar version of Amgen Inc's arthritis drug Enbrel. (Source: Reuters: Health)
Source: Reuters: Health - August 30, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
Biosimilar version of etanercept gains FDA approval
A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.
Approval for all of Enbrel’s... (Source: Skin and Allergy News)
Source: Skin and Allergy News - August 30, 2016 Category: Dermatology Source Type: news
FDA approves Erelzi, a biosimilar to Enbrel
The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 30, 2016 Category: American Health Source Type: news
RheumNow: Could Etanercept Lower Alzheimer's Risk?
(MedPage Today) -- Epidemiological data warrant further study of TNF inhibitors (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - August 12, 2016 Category: Psychiatry Source Type: news
Amgen Profit Rises 13%, 2016 Outlook Raised
Amgen Inc. said its second-quarter earnings rose 13% on better-than-expected revenue growth, which was again driven by sales of key drugs such as Enbrel. < div class="feedflare" > < a href="http://feeds.feedburner.com/~ff/wsj/xml/rss/3_7089?a=yyRa9fHYrdM:BBepALeqcLo:yIl2AUoC8zA" > < img src="http://feeds.feedburner.com/~ff/wsj/xml/rss/3_7089?d=yIl2AUoC8zA" border="0" > < /img > < /a > < a href="http://feeds.feedburner.com/~ff/wsj/xml/rss/3_7089?a=yyRa9fHYrdM:BBepALeqcLo:F7zBnMyn0Lo" > < img src="http://feeds.feedburner.com/~ff/wsj/xml/rss/3_7089?i=yyRa9fHYrdM:BBepALeqcLo:F7zBnMyn0Lo" border="0" > < /img > < /a > < a href="...
Source: WSJ.com: Health - July 27, 2016 Category: Pharmaceuticals Tags: PAID Source Type: news
Amgen 2nd-quarter profit tops Street view, raises 2016 forecast
(Reuters) – Amgen (NSDQ:AMGN) on Wednesday reported higher-than-expected 2nd-quarter profit on increased sales of its blockbuster rheumatoid arthritis drug Enbrel and newer medicines, and the company again raised its full-year forecast.
The forecast appeared to signal management’s confidence in the 2nd half of the year.
The company is on track to meet or exceed its long-term objectives,” Chief Executive Robert Bradaway said in a statement.
Amgen said it now expects 2016 adjusted earnings per share of $11.10 to $11.40, up from its prior view of $10.85 to $11.20. Its midpoint is above of Wall Street esti...
Source: Mass Device - July 27, 2016 Category: Medical Equipment Authors: MassDevice Tags: Business/Financial News Drug-Device Combinations Amgen Source Type: news
Amgen Reports Second Quarter 2016 Financial Results
THOUSAND OAKS, Calif., July 27, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2016. Key results include:
Revenues increased 6 percent versus the second quarter of 2015 to $5.7 billion.
Product sales grew 5 percent driven by Enbrel® (etanercept), Prolia® (denosumab), KYPROLIS® (carfilzomib) and XGEVA® (denosumab).
GAAP earnings per share (EPS) increased 15 percent to $2.47 driven by higher revenues and higher operating margins.
GAAP operating income increased 15 percent to $2,380 million and GAAP operating margin improved by 3.8 percentage...
Source: Amgen News Release - July 27, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Versions
Six years after the Affordable Care Act cleared the way for biosimilars, as the generic versions of biotechnology drugs are called, progress has been slow. (Source: NYT Health)
Source: NYT Health - July 16, 2016 Category: Consumer Health News Authors: ANDREW POLLACK Tags: Drugs (Pharmaceuticals) Biotechnology and Bioengineering Generic Brands and Products Prices (Fares, Fees and Rates) Amgen Inc AbbVie Inc Source Type: news
Biosimilar to Enbrel Unanimously Recommended by FDA Panel Biosimilar to Enbrel Unanimously Recommended by FDA Panel
The US Food and Drug Administration ' s Arthritis Advisory Committee unanimously recommended approval of GP2015 as a biosimilar to Enbrel (etanercept). < br / > < i > Medscape Medical News < /i > (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - July 14, 2016 Category: Dermatology Tags: Dermatology News Source Type: news
Biosimilar to Enbrel Unanimously Recommended by FDA PanelBiosimilar to Enbrel Unanimously Recommended by FDA Panel
The US Food and Drug Administration's Arthritis Advisory Committee unanimously recommended approval of GP2015 as a biosimilar to Enbrel (etanercept). Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 14, 2016 Category: Consumer Health News Tags: Dermatology News Source Type: news
FDA advisory panel unanimously backs biosimilars for Humira, Enbrel
The Food and Drug Administration’s Arthritis Advisory Committee, together with an added complement of dermatologists and gastroenterologists, unanimously recommended during meetings on July 12 and 13 that the agency license a biosimilar Humira (adalimumab) that is made by Amgen and a biosimilar... (Source: Skin and Allergy News)
Source: Skin and Allergy News - July 13, 2016 Category: Dermatology Source Type: news
FDA advisory panel unanimously backs biosimilars for Humira, Enbrel
The Food and Drug Administration’s Arthritis Advisory Committee, together with an added complement of dermatologists and gastroenterologists, unanimously recommended during meetings on July 12 and 13... (Source: Family Practice News)
Source: Family Practice News - July 13, 2016 Category: Primary Care Source Type: news
FDA panel supports Novartis version of Amgen arthritis drug
(Reuters) - Novartis AG's cheaper version of Amgen Inc's arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - July 13, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
