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- Takeda Responds to the FDA Advisory Committee Recommendation
- DEERFIELD, Ill. -- Following a joint meeting today of the U.S. Food and Drug Administration FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development TGRD underscores its position that ACTOS([R]) pioglitazone HCl offers a proven safety profile regarding...
- Research articles 2007-07-30
- Takeda Responds to the FDA Advisory Committee Recommendation
- Following a joint meeting today of the U.S. Food and Drug Administration FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development TGRD underscores its position that ACTOS® pioglitazone HCl offers a proven safety profile regarding the risk of...
- Research articles 2007-07-30
- Takeda Pharmaceutical Receives FDA Fast Track Designation for TAK-
- Tokyo, July 29, 2005 - JCN - Takeda Pharmaceutical announced on July 27 that one of its US affiliates, Takeda Global Research & Development Center of Illinois, has received fast track designation by the US Food and Drug Administration FDA for TAK-242, its investigational compound designed for the treatment of...
- Research articles 2005-07-29
- Takeda Responds to the FDA Advisory Committee Recommendation.
- LONDON, July 31 /PRNewswire/ -- LONDON, July 31 /PRNewswire/ --
- Research articles 2007-07-31
Additional Resources
- FDA: Takeda Ad for Velcade Was Not Funny Enough
- The FDA has warned Takeda's Millenium Pharma unit that utilizing a double entendre in a reminder ad is a violation of drug marketing law. The warning letter will be carefully noted by drug marketers their copywriting agencies and compliance departments as another restriction on their creativity. by Jim Edwards
- Blog posts 2009-06-24
- ACTOplus met(TM) (pioglitazone HCl and metformin HCl) Approved by the FDA for Type 2 Diabetes
- Takeda Pharmaceuticals North America, Inc. TPNA today announced that the U.S. Food and Drug Administration FDA has approved the New Drug Application NDA for ACTOplus metTM for the treatment of type 2 diabetes. This is the second Takeda product approved in the U.S. this summer, following the approval of...
- Research articles 2005-08-29
- Not Just Diabetes: FDA Eyes Expanded CV Data for a Range of Drug Categories
- More detail is emerging about what the FDA wants to see from drugmakers in terms of managing heart and cardiovascular side effects in new drug applications. BNET reported Nov. 17 that the FDA was in the process of sending letters to companies developing new diabetes drugs that said the feds...
- Blog posts 2008-11-25
- FDA Approved ROZEREM(TM) (ramelteon), First and Only Non-Scheduled Prescription Sleep Medication
- Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration FDA has approved the New Drug Application NDA for ROZEREMTM ramelteon 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use...
- Research articles 2005-07-22
- Buying ViroPharma Ahead of June 3rd FDA Decision
- Mark Cifra submits: Is it just me or does it seem like the good old days of biotech are back? With monster moves from Dendreon DNDN and Map Pharma MAPP based on positive phase 3 data, buyouts of IDM Pharma IDMI by Takeda and Cougar Biotech CGRB by [[JNJ]] and...
- External links 2009-05-28
- AMITIZA(TM) (lubiprostone), the First Selective Chloride Channel Activator for the Treatment of Chronic Idiopathic Constipation, Launches in the United States
- Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc., announced today that AMITIZATM lubiprostone, 24-mcg soft-gel capsules, approved by the U.S. Food and Drug Administration FDA in January 2006, is now available by prescription in pharmacies across the United States for the treatment of chronic idiopathic constipation in adults. AMITIZA...
- Research articles 2006-04-25
- AMITIZA® 8 mcg Now Available to Treat Irritable Bowel Syndrome with Constipation in Adult Women
- AMITIZA 8 mcg dose is the only widely available FDA-approved prescription medication for Irritable Bowel Syndrome with Constipation BETHESDA, Md. & DEERFIELD, Ill. -- Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced that AMITIZA([R]) lubiprostone 8 mcg capsules are now available by prescription in...
- Research articles 2008-05-27
- AMITIZA(R) (lubiprostone) 8 mcg Now Available to Treat Irritable Bowel Syndrome With Constipation in Adult Women
- Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced that AMITIZA® lubiprostone 8 mcg capsules are now available by prescription in pharmacies across the U.S. for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years and older. AMITIZA 24 mcg capsules...
- Research articles 2008-05-27
- Is Pfizer's Sleeping Pill Obsession Running up King Stock?
- Trading in options on King Pharmaceuticals shares reached a four-year frenzy yesterday, Reuters reported, and King shares rose to an 11-month high on rumors that Pfizer may be interested in acquiring it. Pfizer pfollowers know that CEO Jeff Kindler made a lot of noise a few years...
- Blog posts 2008-08-06
- DotW: Sesame Street
- In case you failed to run a Google search this week, you may not have realized that on Tuesday Nov. 10, Sesame Street turns 40. You gotta admit, the show doesn't look a day over five--and that's without Botox.If you've forgotten how to get to Sesame Street, we have a...
- News items 2009-11-06
- GlaxoSmithKline Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionKevin Wilson - Citigroup Yeah, thank you this Kevin Wilson from Citigroup in London. Three questions, if I may, JP. Firstly, in the U.S., the 2% decline in sales in the quarter. Could you break out the volume and any price element you saw, and perhaps also comment...
- Earnings calls 2007-07-25
- Vanda Vaults From Dog House to Drug Approval
- If there was one biotech on every banker's list of cash shells, one dog that could make bankruptcy look like a good option, one name synonymous with snickers and snide comments, it was Vanda Pharmaceuticals. Which makes the FDA's approval of Vanda's schizophrenia drug Fanapt iloperidone surprising, to say the least. ...
- Blog posts 2009-05-08
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