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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (1310)	1/15/1999 12:57:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 1722

Yesterday's "Bottle Report" commented on Rezulin investigation. Details linked to Ligand's Diabetes page at biocognizance.com

To: Anthony Wong who wrote (1310)	1/16/1999 5:50:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

FDA Slashed Review Times, Approved 39 All-New Drugs in 1998 Bloomberg News January 15, 1999, 6:55 p.m. ET FDA Slashed Review Times, Approved 39 All-New Drugs in 1998 Washington, Jan. 15 (Bloomberg) -- The U.S. Food and Drug Administration slashed its review times and approved 39 all-new medicines in 1998. In two separate reports, the FDA and the Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, hailed the progress made by the agency in reviewing new drugs faster. In 1998, the FDA cut its average drug review time to 11.7 months from 16.2 months in 1997, PhRMA said. The 39 approvals included much anticipated drugs such as Pfizer Inc.'s Viagra anti-impotence pill and Monsanto Co.'s arthritis painkiller Celebrex. Nine of the approvals were from the biotechnology sector, including Immunex Corp.'s Enbrel for rheumatoid arthritis, Centocor Inc.'s Remicade for Crohn's disease and Genentech Inc.'s Herceptin for breast cancer. ''The medicines approved this year will address diseases that affect more than 180 million patients and cost more than $400 billion a year,'' said Alan Holmer, president of PhRMA. The cut in review times may well be used as ammunition by critics of the FDA who say the agency is at times moving too fast to approve drugs before understanding their risks. The industry is coming off a record spate of drug withdrawals due to safety concerns, though the FDA and industry representatives continue to insist that the system works. The faster approvals are due to a law which mandates quicker reviews in return for company fees used to hire new personnel -- not to the FDA letting down its guard, Holmer told reporters at a PhRMA briefing. ''Standards have not been lowered,'' Holmer said. ''If anything they've been raised.'' Separately, PhRMA said it expects U.S.-based drug companies to spend a record $24 billion on research and development in 1999, up from an estimated $21.1 billion in 1998. On the devices side, the FDA said it approved 46 so-called premarket approval applications in the fiscal year ending Sept. 30, 1998. PMAs are the most intricate kinds of applications and are generally used for complicated or innovative devices. The average review time for the approved PMAs in fiscal year 1998 was 12.4 months, the FDA said. That's down from 16.6 months in fiscal year 1997 and 25.9 months in fiscal year 1996, the agency said. --Kristin Jensen in the Washington newsroom (202) 624-1843