Neuroscience
A company press release regarding a treatment for brain tumors:
- News From The Fda: Onfi Tablets (clobazam) For Adjunctive Treatment In Lennox-gastaut Syndrome
From the FDA: FDA NEWS RELEASE For Immediate Release: Oct. 24, 2011 FDA approves Onfi to treat severe type of seizures On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Business World: Cyberonics, Neurostimulator (vagus Nerve Stimulator [vns]), And Depression
News about this controversial issue (See the list at the bottom of this posting for earlier BrainBlog posts.) From the company's press release:FDA APPROVES CYBERONICS’ VNS THERAPY™ SYSTEM FOR TREATMENT-RESISTANT DEPRESSION (TRD) First FDA-Approved...
- Business World: Ecopia's Eco-4601 And The Blood-brain Barrier
This corporate press release on BusinessWire about a drug candidate for treatment of primary brain tumors: Ecopia's Lead Cancer Compound Shown to Cross Blood-Brain Barrier September 23, 2004 08:26 AM US Eastern Timezone ...
- Cymbalta And Diabetic Peripheral Neuropathy
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release: FDA Approves Drug for Neuropathic Pain Associated With Diabetes Today...
Neuroscience
Business World: Guilford Pharm's Gliadel
A company press release regarding a treatment for brain tumors:
Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer; Market Exclusivity for GLIADEL(R) Extends Until 2010
BALTIMORE, Sept. 27 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that it has received notice from the United States Food and Drug Administration (FDA) that GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), the Company's proprietary brain cancer treatment, is entitled to seven years of market exclusivity for the treatment of patients with malignant glioma undergoing primary surgical resection. The seven-year period of exclusivity under the Orphan Drug Act commenced on the date of approval in February 2003 and extends until February 2010.
The FDA's orphan drug program is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.
"Today's news is the latest in a series of positive developments for GLIADEL(R) announced over the last several weeks," commented Craig R. Smith. M.D., President and Chief Executive Officer. "In August, we reported that GLIADEL(R) had been assigned to a new Diagnosis Related Group (DRG) by the Centers for Medicare and Medicaid Services. The new DRG, which will take effect on October 1, 2004, is expected to improve access to GLIADEL(R) by providing increased payment to hospitals that provide it to their Medicare patients. In addition, last week we reported that GLIADEL(R) had received marketing authorization in Europe."
"Our patent protection for GLIADEL(R) ends in August 2006. Orphan Drug Designation for GLIADEL(R) gives us an additional four years of market exclusivity in the United States for patients undergoing primary surgical resection," continued Dr. Smith. "While we believe our manufacturing process for GLIADEL(R) is sufficiently complex to deter others from making the product, this new period of exclusivity ensures they cannot market it for this indication."
[ ... Read the full press release ... ]
- News From The Fda: Onfi Tablets (clobazam) For Adjunctive Treatment In Lennox-gastaut Syndrome
From the FDA: FDA NEWS RELEASE For Immediate Release: Oct. 24, 2011 FDA approves Onfi to treat severe type of seizures On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Business World: Cyberonics, Neurostimulator (vagus Nerve Stimulator [vns]), And Depression
News about this controversial issue (See the list at the bottom of this posting for earlier BrainBlog posts.) From the company's press release:FDA APPROVES CYBERONICS’ VNS THERAPY™ SYSTEM FOR TREATMENT-RESISTANT DEPRESSION (TRD) First FDA-Approved...
- Business World: Ecopia's Eco-4601 And The Blood-brain Barrier
This corporate press release on BusinessWire about a drug candidate for treatment of primary brain tumors: Ecopia's Lead Cancer Compound Shown to Cross Blood-Brain Barrier September 23, 2004 08:26 AM US Eastern Timezone ...
- Cymbalta And Diabetic Peripheral Neuropathy
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release: FDA Approves Drug for Neuropathic Pain Associated With Diabetes Today...