The Myeloma Beacon Staff's Archive

The Myeloma Beacon Staff has written 722 article(s) .

[ by | Nov 25, 2014 3:02 pm | No Comments ]
FDA Postpones Decision On Panobinostat Approval Application

The U.S. Food and Drug Administration (FDA) has postponed for up to three months its decision on pano­bino­stat’s new drug application.

The FDA action was announced earlier this morning in a press release issued by Novartis (NYSE:NVS), the Swiss pharmaceutical company developing pano­bino­stat as a potential new multiple myeloma therapy.

A decision on pano­bino­stat’s application for FDA approval had been expected by the end of this week. The decision was widely anticipated to be a negative one, …

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[ by | Nov 6, 2014 5:18 pm | One Comment ]
Panobinostat Fails In Bid For FDA Advisory Committee Support

Panobinostat had an important appointment this morning with a group of on­col­o­gists.

The appointment did not go so well.

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) conducted a four-hour review of panobinostat (Farydak) earlier today.

At the end of the meeting, members of the committee were asked to vote whether they felt the benefits of panobinostat as a potential treatment for relapsed myeloma outweighed its risks.

Five committee members voted "no." …

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[ by | Nov 6, 2014 4:08 am | 2 Comments ]
Live Coverage Of The Panobinostat FDA Advisory Committee Meeting

The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Adminis­tra­tion will convene this morning to review pano­bino­stat, and The Myeloma Beacon will provide live coverage of the meeting.

Beacon staff members will post frequent updates at the webpage for this article as the meeting proceeds. Coverage will begin at the start of the meeting at 8 a.m. Eastern Time, which is when the review of pano­bino­stat (Farydak) is scheduled to begin.

The Swiss pharmaceutical company Novartis (NYSE:NVS) …

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[ by | Nov 4, 2014 11:46 pm | 3 Comments ]
Panobinostat’s FDA Advisory Committee Meeting May Be A Bit Tougher Than Expected

As reported earlier today by The Beacon, the U.S. Food & Drug Admin­is­tra­tion (FDA) this morning released key documents related to the agen­cy’s review of pano­bino­stat as a potential new treatment for multiple myeloma.

The documents consist of briefing reports, agendas, and other sup­port­ing material for the meeting of the FDA’s Oncologic Drugs Advisory Com­mit­tee (ODAC) this coming Thursday. The morning session of that meet­ing will be devoted to a review of pano­bino­stat (Farydak), which is being developed by the …

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[ by | Nov 4, 2014 10:21 am | 2 Comments ]
FDA Releases Key Documents Related To Panobinostat Advisory Committee Meeting

The U.S. Food and Drug Administration this morning released important in­for­ma­tion related to its Oncologic Drugs Advisory Committee meeting scheduled for this Thursday, when the committee will review data related to the application by Novartis (NYSE:NVS) to have pano­bino­stat (Farydak) approved as a new treatment for multiple myeloma.

In addition to a draft agenda and draft committee roster, the Food and Drug Administration (FDA) released briefing information for the com­mit­tee members and a question about the …

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