Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Page 81283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Oncologic Drugs Advisory Committee; Cancellation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The meeting of the Oncologic Drugs Advisory Committee
scheduled for February 9, 2011, is cancelled. This meeting was
announced in the Federal Register of December 6, 2010 (75 FR 75680). On
February 9, 2011, the Oncologic Drugs Advisory Committee was scheduled
to discuss biologics license application (BLA) 125377, with the
proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers
Squibb Co. The proposed indication (use) for this product is for the
treatment of advanced melanoma in patients who have received prior
therapy. This meeting has been cancelled because the issues for which
FDA was seeking the scientific input of the committee have been
resolved.
FOR FURTHER INFORMATION CONTACT: Nicole Vesely, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, e-mail: Nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), and follow the prompts to the desired center
or product area. Please call the Information Line for up-to-date
information on this meeting.
Dated: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32413 Filed 12-23-10; 8:45 am]
BILLING CODE 4160-01-P
“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
~Charles Darwin~
Take Care,
Jimmy B
Bristol-Myers CEO: Drug Pricing Pressure Remains In Europe
ReplyDeleteJan 6, 2011 08:36:12 (ET)
By Peter Loftus
Of DOW JONES NEWSWIRES
Bristol-Myers Squibb Co.'s (BMY) leader said pressure on drug prices in Europe remains a challenge that could hurt financial results in 2011.
Chief Executive Lamberto Andreotti told a Goldman Sachs investor conference Thursday that European pricing pressure was "going in a negative direction." Last year, national health programs in Europe imposed significant reductions on the prices they pay for prescription drugs, to help close budget gaps.
"In Europe, we have a situation where price reductions and rebates will be much heavier than in the past," Andreotti said in remarks available by webcast.
In the past, Bristol experienced annual price reductions of 2% to 2.5% in Europe, Andreotti said. Now, it's expecting cuts of 5% to 6%.
"What I believe the market does not appreciate fully is that some of these measures are going to affect more of the so-called mature brands," Andreotti said.
He didn't specify which products he had in mind, but the phrase "mature brands" typically refers to older products including those that have lost patent protection.
New York-based Bristol markets the blockbuster anti-clotting drug Plavix, which is expected to lose U.S. market exclusivity next year, clearing the way for sales-eroding generic competition.
To offset some of these pressures, Bristol hopes to bring some promising new drugs to the market, including an experimental skin-cancer treatment, ipilimumab, which Bristol submitted for Food and Drug Administration approval last year. Andreotti said Thursday the company has had discussions with the FDA regarding the product label for ipilimumab.
He also said the company has filed for regulatory approval of an experimental diabetes drug, dapagliflozin.
-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires