ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much mor > Novartis has scooped up a bigger share of Alnylam stock.The pharma giant now owns 13.3 percent of the company.
Alnylam release > Curious how the FDA might spend its PDUFA fees?
A new five-year plan shows that ...
Senate Version Of Supplemental War Appropriations Bill Would Delay Medicaid Regulations, Increase FDA Funds The on Thursday plans to mark up a supplemental war appropriations bill that will include language to block for one year seven new Medicaid regulations proposed by the Bush administration, as well as additional funds for FDA, CQ Today...
FDA delays Entereg decision GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay.The FDA informed the companies that it would not make a decision by Saturday, the drug's PDUFA date.
No date was...
US FDA feels the heat from Congressional hearings A series of recent drug scandals and regulatory lapses in the USA are setting the stage for major reform of the US Food and Drug Administration.Experts say the agency needs more human and financial resources to ensure that the country's...
Omrix Biopharmaceuticals Inc. Earnings Call Transcript Good day ladies and gentlemen and welcome to the first quarter 2008 OMRIX Biopharmaceuticals financial results conference call.My name is Lacy and I'll be your coordinator for today.
(Operator Instructions) I would now like to turn the...
Osiris Receives Approval for Use of Prochymal Under FDA Expanded Access Treatment Program - Osiris Therapeutics, Inc.(NASDAQ:OSIR) today announced it has been given clearance by the U.S.
Food and Drug Administration (FDA) to initiate an expanded access treatment program for Prochymal, making the investigational stem...
Hereditary Angioedema drug, Cinryze, accepted for FDA review Lev is seeking marketing approval for Cinryze for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.In addition, the FDA has designated Lev's complete response as a Class...
Eurand Reports First Quarter 2008 Key Achievements and Financial Results * EUR-1008 (Zentase(r)) NDA accepted and granted priority review status by FDA * EUR-1008 (Zentase(r)) MAA received eligibility for centralized review procedure in European Union * In-licensed corticosteroid product for inflammatory...
Stem Cell treatment, Prochymal, for GvHD approved by FDA Prochymal, a formulation of adult mesenchymal stem cells administered through a standard intravenous line, is currently in Phase III clinical trials, the final stage of clinical testing before submission to FDA for marketing approval....
Lev Pharmaceuticals Announces Cinryze Complete Response Submission Accepted for Review by FDA - Lev Pharmaceuticals, Inc.(OTCBB: LEVP.OB) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze(TM) (C1 inhibitor), the Company's lead product...
The FDA scale-up: good for big pharma or not? Fact: the FDA relies on user fees since the 1990s with the goal of speeding up drug approvals, meaning it is severely underfunded by the federal government and has not been able to fulfill it's mission based on that alone...NOW the ...
Adolor Provides Regulatory Update on Entereg(R) (alvimopan) EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (Nasdaq:ADLR - News) announced today that the U.S.Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg...
FDA says wider use of Cephalon drug carries risks of misuse By MATTHEW PERRONE AP Business Writer WASHINGTON (AP) - Government regulators on Friday said encouraging wider use of a powerful painkiller made by Cephalon Inc.raises the risk of potentially fatal misuse of the drug.
Shares of the...
Senate version of supplemental war appropriations bill would delay Medicaid regulations, increase FDA funds The on Thursday plans to mark up a supplemental war appropriations bill that will include language to block for one year seven new Medicaid regulations proposed by the Bush administration, as well as additional funds for FDA, CQ Today...
FDA again delays decision on Adolor drug Adolor said the Food and Drug Administration will not issue an 'action letter' by tomorrow, which had been the expected decision date.The FDA told the company it expects to issue the action letter 'shortly.' Adolor shares fell 10...
FDA Sets Panel Review of Glaxo Clotting Drug: Amgen LOS ANGELES (Reuters) May 08 - A panel of expert advisers to the U.S.Food and Drug Administration will meet at the end of this month to review GlaxoSmithKline Plc's experimental drug for treating a disorder in which the blood does not...
FDA again delays decision on Adolor drug Adolor Corp.said today that federal regulators again delayed a decision on marketing approval of the Exton company's first product, the experimental bowel medicine Entereg.Adolor said the Food and Drug Administration will not issue an ...
Eurand Reports First Quarter 2008 Key Achievements and Financial Results Highlights: * EUR-1008 (Zentase(r)) NDA accepted and granted priority review status by FDA * EUR-1008 (Zentase(r)) MAA received eligibility for centralized review procedure in European Union * In-licensed corticosteroid product for...
Eurand Reports First Quarter 2008 Key Achievements and Financial Eurand NV (EURX) Stock Quote, Chart, News, Add to Watchlist All PrimeNewswire news Highlights: * EUR-1008 (Zentase(r)) NDA accepted and granted priority review status by FDA * EUR-1008 (Zentase(r)) MAA received eligibility for...
FDA sets panel review of Glaxo clotting drug: Amgen LOS ANGELES (Reuters) - A panel of expert advisers to the U.S.Food and Drug Administration will meet at the end of this month to review GlaxoSmithKline Plc's experimental drug for treating a disorder in which the blood does not clot...
FDA Approves Health Claim for Brown Rice Brown rice, a 100 percent whole grain food, joins the recognized ranks of healthful whole grains, according to an announcement this week from the U.S.Food and Drug Administration (FDA) that will allow brown rice food labels to bear...
AACE Calls for New Standards for Safer Insulin Pump Use 'The American Association of Clinical Endocrinologists applauds the FDA's efforts to protect the safety of children and adolescents who are using insulin pumps,' said Dr.Richard Hellman, the Association's President.
In the May...
Osiris Receives Approval for Use of Prochymal(TM) Under FDA Expanded Access Treatment Program Decision Makes Investigational Stem Cell Treatment Available to Critically Ill Children COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc.(NASDAQ:OSIR - News) today announced it has been given clearance by the U.S.
Food and Drug...
Arena Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript Before I begin, Id like to point out that we will be making numerous forward-looking statements during this conference call.Such forward-looking statements include statements about our clinical trials and results, internal and partnered...
Congress, FDA Weigh in on Measures to Improve Drug Safety ePT--the Electronic Newsletter of Pharmaceutical Technology Washington, DC (May 1)Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft.Among the measures under consideration are...
