Wednesday, June 07, 2006

US FDA reinstates Tysabri for multiple sclerosis


US FDA reinstates Tysabri for multiple sclerosis
PharmaBiz Tue, 06 Jun 2006 9:38 PM PDT
Biogen Idec and Elan Corporation, plc announced the approval of a supplemental Biologics License Application (sBLA) by the US Food and Drug Administration (FDA) for the reintroduction of Tysabri (natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses.

Betaferon(R) Approved in Europe As a First-Line Treatment for the Earliest Stages of Multiple Sclerosis
RedNova Wed, 07 Jun 2006 5:10 AM PDT
BERLIN, June 7 /PRNewswire-FirstCall/ -- Scher

Quick takes on health
Rochester Democrat and Chronicle Wed, 07 Jun 2006 5:21 AM PDT
Actor speaks on multiple sclerosis Psychologist talks about patient-doctor communication Second Opinion health conference Friday Sonnenberg Gardens offers outdoor exercise

Health Business
UPI Wed, 07 Jun 2006 8:54 AM PDT
BERLIN, June 7 (UPI) -- Schering said Wednesday the European Commission approved its Betaferon for the treatment of multiple sclerosis.

DAILY CHECK-UP
Lexington Herald-Leader Wed, 07 Jun 2006 0:14 AM PDT
A multiple sclerosis drug pulled from the market last year because of a rare but life-threatening side effect will return under a restricted distribution program. The Food and Drug Administration said it will allow Biogen Idec Inc. and Elan Corp. PLC to resume selling Tysabri under a program that requires doctors, pharmacies and patients to register with a program designed to ensure the safe use

Analysis: Tysabri Won't Top Current Drugs
RedNova Tue, 06 Jun 2006 6:12 PM PDT
By STEVE MITCHELL The Food and Drug Administration's approval of Biogen Idec's multiple-sclerosis treatment Tysabri to return to the market is a positive for the company, but analysts said the drug won't replace the current therapies for the disorder.

MS Drug Back on Market: Medicine Approved By the FDA and Pulled After Being Linked to Rare Brain Infection Will Now
RedNova Tue, 06 Jun 2006 5:15 PM PDT
By Kathleen Kerr, Newsday, Melville, N.Y. Jun. 6--A controversial multiple sclerosis drug pulled off the market after two patients who used it contracted fatal brain infections may be sold once again, the Food and Drug Administration said yesterday.

Biggest Specialty Drug Spending Increase Found With Anti-Inflammatories
HealthDay via Yahoo! News Wed, 07 Jun 2006 6:02 AM PDT
WEDNESDAY, June 7 (HealthDay News) -- Americans spent 33.9 percent more in 2005 on anti-inflammatories -- the biggest percentage increase in any specialty drug category, a new U.S. report finds.

Global Report: People Problems
Pharmaceutical Executive Wed, 07 Jun 2006 7:58 AM PDT
A recent clinical trials disaster is causing UK regulators to consider revising its guidelines for Phase I human studies for biologics. However, in many cases, potential solutions present additional problems.

MEDICAL TECHNOLOGY: Investing in Imaging: Oakwood to Buy Machines in Deal With GE Healthcare
RedNova Wed, 07 Jun 2006 5:12 AM PDT
By Katie Merx, Detroit Free Press Jun. 7--Oakwood Hospital Inc. has struck a $50-million deal with GE Healthcare to buy the latest diagnostic imaging equipment, including ultrasound machines and MRIs over the next five years.

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