But in early 2010, the FDA's Oncologic Drugs Advisory Committee voted 7-1 calling for a companion diagnostic to identify patients with that mutation and an official FDA rejection followed. (See BioWorld Today, March 23, 2010.) ChemGenex resubmitted the new drug application a few months later, seeking approval in all CML patients, regardless of genetic mutation, based on combined data from two pivotal studies. (See BioWorld Today, July 15, 2010.) Beyond CML, Teva is "looking at additional

In a two-day meeting that begins this morning, the FDA's Drug Safety and Risk Management (DSaRM) Advisory Committee (adcom) will examine the potential impact of rescheduling hydrocodone combination products – those mixed with other analgesics or as an antitussive – from Schedule III to II, similar to hydrocodone alone

Among those is Kynamro (mipomersen) for homozygous familial hypercholesterolemia, which the Endocrinologic and Metabolic Drugs Advisory Committee endorsed in a meeting last week

Following a 10-0 vote by the FDA's Dermatologic and Ophthalmic Drug Advisory Committee in favor of its approval earlier this year, there was little doubt that Jetrea would get over the line. (See BioWorld Today, Jul. 27, 2012.) Crucially, however, there was no sting in the tail, in terms of the label

Gattex is under FDA review, and an advisory committee recently voted in favor of approval of the recombinant analogue of glucagon-like peptide-2 in SBS. (See BioWorld Today, Oct. 17, 2012

Hemispherx Biopharma Inc., of Philadelphia, said the FDA confirmed that it has scheduled for Dec. 20 a meeting of the Arthritis Advisory Committee to discuss the Ampligen new drug application for chronic fatigue syndrome, currently under review by the agency

The FDA's Gastrointestinal Drugs Advisory Committee voted unanimously that NPS Pharmaceuticals Inc.'s Gattex (teduglutide) for short bowel syndrome should be approved...Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9-6 in favor of recommending approval for Kynamro (mipomersen), from Genzyme, a unit of Sanofi SA, (developed by Isis Pharmaceuticals Inc.), for homozygous familial hypercholesterolemia

Following a 10-0 vote by the FDA's Dermatologic and Ophthalmic Drug Advisory Committee in favor of its approval earlier this year, there was little doubt that Jetrea would get over the line. (See BioWorld Today, Jul. 27, 2012.) Crucially, however, there was no sting in the tail, in terms of the label

Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) balloted 9-6 in favor

Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) cast their ballots 13-2 in favor of recommending approval of lomitapide, a microsomal triglyceride transfer protein inhibitor from Cambridge, Mass.-based Aegerion

The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted unanimously Tuesday that the benefits of NPS Pharmaceuticals Inc.'s Gattex (teduglutide) for short bowel syndrome (SBS) outweighed its risks, and that the drug should be approved

Paperwork ahead of the meeting Wednesday and Thursday of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) listed questions about tumor growths in rat and mice subjects given mipomersen

Although an FDA Oncologic Drugs Advisory Committee recently voted in favor of its clinical utility, the company still has to conduct a second, confirmatory trial

The FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at a meeting tentatively scheduled for March 4, 2013

Cholesterol-lowering drug candidates are in the spotlight this week with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting Wednesday and Thursday to pass judgment on two of those drugs – lomitapide from Aegerion Pharmaceuticals Inc

Advisory Committee voted against approval 9/14/12 CENTRAL NERVOUS SYSTEM Orexo AB (Uppsala, Sweden) Zubsolv OX219

Briefing documents that were released ahead of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting for short bowel drug Gattex (teduglutide) held "no surprises" according the drugmaker, NPS Pharmaceuticals Inc...Bedminster, N.J.-based NPS has prepared exhaustively for the upcoming advisory committee meeting

In April 2010, the Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs constitute a distinct group and that the FDA should develop a formal list of those drugs, he pointed out

Celgene Corp., of Summit, N.J., said it was notified by the FDA that there will not be an Oncologic Drugs Advisory Committee meeting scheduled for Nov. 8