Navigation Links
Amgen To Provide Testimony At FDA Stakeholder Hearing On Biosimilars
Date:5/11/2012

THOUSAND OAKS, Calif., May 11, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that Joseph P. Miletich, M.D., Ph.D., senior vice president of Research and Development at Amgen will testify at the United States (U.S.) Food and Drug Administration (FDA) stakeholder hearing on biosimilars. Miletich will urge members of the FDA panel charged with implementing a pathway for biosimilars to establish approval standards that advance patient safety and promote confidence in biosimilars marketed in the U.S.

In his opening remarks, Miletich will underscore the wealth of experience Amgen brings to the discussion on biosimilars approval pathway implementation. "As a leading provider of high quality biologic medicines, Amgen appreciates the challenges of developing and manufacturing innovative and biosimilar medicines."

"Put patients first and sound policy will follow," Miletich states.  "Amgen appreciates the FDA's efforts on the guidelines and encourages adoption of a thorough review and approval process. However, Amgen believes some changes and additional clarity are needed."

Noting the complexities of biological products and the potential differences in products created from different living cells, Miletich will emphasize that biotechnology is an evolving field.  "While much more is known today than 30 years ago, FDA's guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," says Miletich.

Miletich will state that "patient safety must be a non-negotiable priority for FDA and manufacturers, and that focus on patient safety does not end with drug approval."  He will outline three key recommendations that the FDA should consider as it finalizes its guidances:  

  1. Adopt policies to facilitate attribution of adverse events and
    '/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Amgen to Present at the Baird Growth Stock Conference
2. Four Californians Selected As Breakaway from Cancer® Champions To Be Honored During Amgen Tour of California
3. Amgen to Acquire Mustafa Nevzat, a Leading Privately Held Turkish Pharmaceutical Company
4. Amgen Announces Webcast of 2012 First Quarter Financial Results
5. UCB and Amgen Initiate Sclerostin Antibody Phase 3 Program in Patients With Postmenopausal Osteoporosis
6. Amgen Completes Tender Offer for Outstanding Shares of Micromet, Inc.
7. Schwartz Center Receives $500,000 Grant from the Amgen Foundation
8. Amgen to Present at the Cowen and Company 32nd Annual Healthcare Conference
9. Amgen and Micromet Announce Early Termination of HSR Waiting Period for Amgens Acquisition of Micromet
10. Amgens Full Year 2011 Revenue Increased 4 Percent to $15.6 Billion and Adjusted Earnings Per Share (EPS) Increased 2 Percent to $5.33
11. Amgen Announces Final Results of Its Tender Offer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)... Resources Group finds that the market for colorectal cancer (CRC) ... in the United States , ... Italy , Spain , the ... . The biosimilar erosion of Roche/Genentech/Chugai,s Avastin and Bristol-Myers Squibb/Eli ... of Eli Lilly,s Cyramza, Taiho Pharmaceutical,s Lonsurf, Alchemia,s HA-irinotecan and ...
(Date:8/28/2014)... YORK , Aug. 28, 2014 Levi ... been commenced in the United States District Court for ... behalf of investors who purchased Galectin Therapeutics Inc. ("Galectin" ... 2014 and July 28, 2014. For more ... complaint alleges that during the Class Period the Company ...
(Date:8/28/2014)... , Aug. 28, 2014 Nonin Medical, ... leader in noninvasive medical monitoring, today announced that the ... Model 3231 OEM/eHealth finger pulse oximeter for use in ... pulse oximeter plugs into a telemedicine hub or kiosk ... pulse rate in pediatric to adult patients. The Model ...
Breaking Medicine Technology:The Colorectal Cancer Market Will Remain Steady at $7.7 Billion by 2023, With Biosimilar Erosion Of Key Agents Being Balanced Out By the Launch Of Premium-Priced Therapies 2SHAREHOLDER ALERT: Levi & Korsinsky, LLP Reminds Investors of Class Action Against Galectin Therapeutics Inc. and Its Board of Directors and a Lead Plaintiff Deadline of September 29, 2014 -- GALT 2Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter 2
... and Company (NYSE: LLY ) today issued ... and chief executive officer about his meeting today with ... job creation, American innovation and competiveness: "It,s ... and take part in this very important dialogue today ...
... Dec. 15, 2010 Johnson & Johnson (NYSE: ... Worldwide Chairman, Medical Devices & Diagnostics (MD&D) and Sheri ... Chairmen of the Executive Committee and join William C. ... in an expanded Office of the Chairman.  Both appointments ...
Cached Medicine Technology:Lilly Statement Regarding President Obama's Meeting With U.S. Business Leaders 2Johnson & Johnson Announces Executive Appointments: Alex Gorsky, Vice Chairman, Executive Committee Sheri McCoy, Vice Chairman, Executive Committee 2Johnson & Johnson Announces Executive Appointments: Alex Gorsky, Vice Chairman, Executive Committee Sheri McCoy, Vice Chairman, Executive Committee 3
(Date:8/29/2014)... Most dentists work during normal business hours. That ... their day to be able to go see the dentist. ... a few hours during their increasingly busy days. That is ... It is now possible for people to get the preventative ... happening? , North York Dental has realized that it is ...
(Date:8/29/2014)... The Florida Chiropractic Association held its National ... week August 21-24 and Maryland and Virginia chiropractor ... , Dr. Greenstein presented at three different sessions: ... standing room session; (2) A Panelist at the Plenary ... the Way in Injury Prevention and Maximizing Human Performance; ...
(Date:8/29/2014)... Recent reports, backed by the US ... are working longer hours and taking fewer vacations than ... believes that drinking lots of purified water can help, ... their most popular and effective water purification systems to ... 9/2/2014, customers can save up to $125 off all ...
(Date:8/29/2014)... Auckland, NZ (PRWEB) August 29, 2014 ... of Greg Allen to Chief Executive Officer effective from ... Chief Technology Officer for Winscribe. , “During this time ... Winscribe than Greg Allen,” said Matthew Weavers, Winscribe’s Founder ... leader with a wealth of commercial, IT and management ...
(Date:8/28/2014)... Peoria, Illinois (PRWEB) August 29, 2014 ... of feeling tired all the time, twenty percent of ... to interfere with their daily life. Adrenal Fatigue is ... if you have more of the classic symptoms. Tasks ... flairs up over things that previously didn’t cause irritation, ...
Breaking Medicine News(10 mins):Health News:North York Dental Provides Dental Services to Busy Professionals 2Health News:Sport and Spine Rehab’s CEO Presents at the Florida Chiropractic Association National Convention and Expo 2014 2Health News:Relax this Labor Day Weekend with Great Savings on Easy-Install, Do-It-Yourself Drinking and Whole House Water Filters 2Health News:Winscribe Names Greg Allen as CEO 2Health News:Peoria AlignLife Clinics Focus on Community Education 2
... NANJING, China, Aug. 5 /PRNewswire-Asia/ -- Simcere Pharmaceutical ... supplier of branded generic and,innovative anti-cancer pharmaceuticals in China, ... quarter results on Monday, August 17, 2009,after the market ... Ren, and chief financial officer, Frank Zhigang Zhao, will,host ...
... , FORT LAUDERDALE, Fla., Aug. 5 ... leading provider of convenient at-home diet, fitness and healthy lifestyle solutions, today ... results after the U.S. equity markets close on Wednesday, August 12, 2009. ... conference call for investors the following day, Thursday, August 13, beginning at ...
... , PARSIPPANY, N.J., Aug. 5 DSM ... facility has received the( )Potent Compound Safety Certification from ... The Certification is for competency and proficiency in the ... potent drug products, and applies to the site,s potent ...
... , HACKENSACK, N.J., Aug 5 ReGen Biologics, a ... regarding its Menaflex collagen meniscus implant that were made in a ... party unaffiliated with the company. ReGen was unaware of ... on the Internet. The statements made in the release do ...
... , , , ... Michigan-based company dedicated to providing custom filling solutions, is now manufacturing ... for this product category in the market. The product line includes ... a growing trend in the hand-sanitizer market for more gentle formulas ...
... , SAN FRANCISCO, Aug. 5 ... to a study just published in the Journal of Gerontology ... risk for poor health outcomes and complications from other disorders. ... ongoing study of healthy adults aged 65 and older funded ...
Cached Medicine News:Health News:Simcere Pharmaceutical Group to Announce 2009 Second Quarter Earnings on Monday, August 17, 2009 2Health News:eDiets.com(R) to Report Second Quarter Fiscal 2009 Results on Wednesday, August 12, 2009 2Health News:DSM Announces SafeBridge(R) Potent Compound Safety Certification 2Health News:DSM Announces SafeBridge(R) Potent Compound Safety Certification 3Health News:ReGen Biologics Clarifies Recent Press about the Menaflex Device 2Health News:Brain Fitness Reduces Risk of Onset of Depressive Symptoms 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: