Center for Drug Evaluation and Research

Type: Organization
Name: Center for Drug Evaluation and Research
First reported Apr 21 2014 - Updated 19 hours ago - 3 reports

Eli Lilly's Cyramza gains FDA approval for stomach cancer

The FDA announced Monday that it approved Eli Lilly's angiogenesis inhibitor Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. The drug is intended for patients whose cancer is unresectable ... [Published FirstWord Pharma - Apr 21 2014]
First reported Apr 17 2014 - Updated Apr 17 2014 - 1 reports

Annual DRI Shameless Plug

Here is our annual publicity stunt for the Defense Research Institute’s Drug and Device Seminar: *************Please join us at the 2014 DRI Drug & Device Seminar May 15 – 16, 2014 at the Renaissance Downtown Hotel in Washington, D.C. The program includes:•           ... [Published Drug and Device Law - Apr 17 2014]
First reported Apr 17 2014 - Updated Apr 17 2014 - 1 reports

FDA Approves New Type 2 Diabetes Drug

body: Millions of Americans with Type 2 diabetes have a new treatment option with the U.S. Food and Drug Administration's approval of a once-weekly injectable drug, Tanzeum. The FDA described Tanzeum (albiglutide) as a "glucagon-like peptide-1 (GLP-1) ... [Published AAPS Pharmceutica - Apr 17 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

New Type 2 Diabetes Treatment Approved

The FDA has approved Tanzeum subcutaneous injection for those living with type 2 diabetes. FDA is requiring post-marketing studies for Tanzeum, including a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients.Apr 16, 2014The FDA ... [Published Occupational Health & Safety - Apr 16 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

FDA Issues Notice about Opioid Analgesics Misuse and Abuse

WASHINGTON, April 10 -- Food and Drug Administration has issued a notice called: Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Request for Comments; ... [Published HighBeam Research - Apr 11 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

Weekly Roundup 4.11.14

A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already ... [Published Eye on FDA - Apr 11 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

How I Lead: Listen, Breathe and Then Ask Questions

Melanie Keller is associate director for management at the Center for Drug Evaluation and Research, the largest center at the Food and Drug Administration. As the executive officer, she oversees administrative operations and a $1 billion annual budget. ... [Published Government Executive - Apr 09 2014]
First reported Apr 07 2014 - Updated Apr 08 2014 - 1 reports

Senate Dems want crackdown on e-cigs

Half a dozen Senate Democrats called Monday on a pair of federal agencies to go after electronic cigarette companies that claim their wares can help smokers quit.The Food and Drug Administration (FDA) is readying regulations that would bring the burgeoning ... [Published The Hill - Apr 07 2014]
First reported Apr 08 2014 - Updated Apr 08 2014 - 1 reports

FDA examining new rules and studies regarding sunscreen safety

The tremendous increase in sunscreen use over the last generation has created a need to reevaluate the safety of its ingredients. So Congress was told by an official of the Food & Drug Administration (FDA) on Monday, April 7.Janet Woodcock, director ... [Published Examiner.com - Apr 08 2014]
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

Living Well: FDA approves pocket protector

A pocket-sized injection device that can deliver medicine to reverse the effects of prescription drug and heroin overdose won fast-track approval from the Food and Drug Administration last week.The EpiPen-like “Evizio” provides a single doze of the drug ... [Published News-Press.com - Apr 07 2014]
First reported Apr 04 2014 - Updated Apr 05 2014 - 2 reports

Va. firm wins FDA approval for overdose treatment

RICHMOND, Va. — A Richmond-based company has received federal approval for a drug treatment that reverses the effects of pain medicine or heroin overdose.According to the Richmond Times-Dispatch (http://bit.ly/1lFCyom ), the U.S. Food and Drug Administration ... [Published Kentucky.com - Apr 04 2014]
First reported Mar 31 2014 - Updated Apr 01 2014 - 1 reports

Week ahead: O-Care enrollment deadline arrives

ObamaCare’s first enrollment period officially comes to a close on Monday, and all eyes will be on the administration to see how many people signed up for coverage in the law’s first year.The White House met its own target last week when officials announced ... [Published The Hill - Mar 31 2014]

Quotes

"Stay upup toto date on new treatments for your condition."
Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, commented: "Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved Cyramza for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes" said Curtis Rosebraugh, M D , M P H , director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research...
"Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies" said Richard Pazdur, M D , director of the Office of Hematology and Oncology Products in the FDA's CenterCenter for Drug Evaluation and Research...

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All (230) | News (213) | Reports (0) | Blogs (14) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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Keeping Healthy When the Economy Is Not [Published Agency for Healthcare Research and Quality - 8 hours ago]
FDA Approves Cyramza for Stomach Cancer [Published Oncology Times - 11 hours ago]
New Stomach Cancer Rx Approved [Published Daily Rx - 13 hours ago]
Lilly's Cyramza first FDA-approved drug for adv... [Published Pharma Letter - 21 hours ago]
FDA nod to Eli Lilly’s angiogenesis inhibitor C... [Published The Utah People's Post - Apr 22 2014]
FDA approves new Eli Lilly drug to treat stomac... [Published Indianapolis Star - Apr 22 2014]
FDA Approves Ramucirumab for Gastric and GEJ Ad... [Published OncLive - Apr 22 2014]
FDA approves new Eli Lilly drug to treat stomac... [Published Indianapolis Star - Apr 21 2014]
Eli Lilly's Cyramza approved for stomach cancer [Published American Journal of Managed Care - Apr 21 2014]
FDA approves Cyramza for stomach cancer [Published Orthopedics Today - Apr 21 2014]
Eli Lilly's Cyramza gains FDA approval for stom... [Published FirstWord Pharma - Apr 21 2014]
FDA approves Tanzeum to treat type 2 diabetes [Published Maryland Bay Net - Apr 21 2014]
FDA approves Cyramza for stomach cancer [Published FierceBiotech - Apr 21 2014]
U.S. FDA approves Eli Lilly drug for stomach ca... [Published Yahoo! Finance - Apr 21 2014]
U.S. FDA approves Eli Lilly drug for stomach ca... [Published Reuters - Apr 21 2014]
Opioid overdose treatment device Evizio approve... [Published Examiner.com - Apr 20 2014]
Anaphylaxis, Epinephrine Auto-Injectors, and Im... [Published U.S.Pharmacist - Apr 18 2014]
CRN: FDA's IND Guidance Could Harm Supplement I... [Published Natural Products Industry Insider - Apr 17 2014]
Annual DRI Shameless Plug [Published Drug and Device Law - Apr 17 2014]
FDA approves portable device to reverse opioid ... [Published Natural News - Apr 17 2014]
FDA Approves New Type 2 Diabetes Drug [Published AAPS Pharmceutica - Apr 17 2014]
US FDA approves Tanzeum to treat type II diabetes [Published Express Pharma - Apr 16 2014]
FDA approves new drug for people with type 2 di... [Published Nurse.com - Apr 16 2014]
FDA finally OKs GlaxoSmithKline’s Tanzeum to tr... [Published Pharma Letter - Apr 16 2014]
FDA approves GSK's Tanzeum for type 2 diabetes [Published Bio Spectrum Asia - Apr 16 2014]
New Type 2 Diabetes Treatment Approved [Published Occupational Health & Safety - Apr 16 2014]
“Rescue Pen” Averts Opioid Overdose Risk [Published Hospi Medica - Apr 16 2014]
FDA wants pharma to move from compliance to qua... [Published Packaging World - Apr 16 2014]
FDA approves once a week diabetes injection: Co... [Published EMax Health - Apr 16 2014]
FDA Approves New Type 2 Diabetes Drug-April 15,... [Published InteliHealth - Apr 15 2014]
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sort by: Date | Relevance
Annual DRI Shameless Plug [Published Drug and Device Law - Apr 17 2014]
Here is our annual publicity stunt for the Defense Research Institute’s Drug and Device Seminar: *************Please join us at the 2014 DRI Drug & Device Seminar May 15 – 16, 2014 at the Renaissance Downtown Hotel in Washington, D.C. The program includes:•           ...
Weekly Roundup 4.11.14 [Published Eye on FDA - Apr 11 2014]
A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already ...
FDA Expands Access to Overdose Antidote to Stem... [Published TIME.com - Apr 03 2014]
The Food and Drug Administration (FDA) has approved the first auto-injecting version of Naloxone as part of the government’s efforts to control the epidemic of opiate addiction and overdoses from narcotic drugs, which include prescription medications ...
Still Burned by the FDA [Published Marginal Revolution - Mar 21 2014]
Excellent piece in the Washington Post on the FDA and sunscreen: …American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade. That’s ...
Director of FDA’s Center for Drug Evaluation an... [Published Business Wire Health News - Mar 17 2014]
HORSHAM, Pa.--(BUSINESS WIRE)--Director of FDA’s Center for Drug Evaluation and Research to Introduce New Office of Pharmaceutical Quality at DIA Annual Meeting ...
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