;
Skip to main content
Home > BioCentury on BioBusiness > Regulation

Chronological Index of : Regulation

 Current Issue
  • Genasense lessons

    Ongoing Phase III cancer trials Genasense Lessons: Playing hard ball Genasense Lessons: Completely confusing Companies designing cancer trials …

    Published on 5/10/2004
  • EPO on the horizon

    EPO on the horizon Selected ongoing, randomized studies looking at the effect of EPO use on cancer outcomes. Only Amgen's 20010145 study is placebo-controlled. With the exception of SE-2002-9001, which has a …

    Published on 5/10/2004
  • Completely confusing

    Investors and analysts who followed Genta Inc.'s development of Genasense …

    Published on 5/10/2004
  • Playing hard ball

    Genasense milestones Last week's meeting of FDA's Oncologic Drugs Advisory Committee to review …

    Published on 5/10/2004
  • Genasense milestones

    Genasense Lessons: Playing hard ball Genasense milestones Selected Genasense events traced against Genta's stock price since Jan. 1, 2002. A. 4/29/02 - Aventis (AVE) and GNTA announce their partnership to jointly …

    Published on 5/10/2004
  • Ongoing Phase III cancer trials

    Cover Story: Regulation: Genasense lessons Ongoing Phase III cancer trials Phase III protocols for selected ongoing cancer trials show that few sponsors have chosen progression-free survival over overall survival as…

    Published on 5/10/2004
  • ODAC won't rush to judgment on EPO

    Sending signals EPO on the horizon Although encouraged by FDA officials to endorse new clinical trials to assess the safety of long-…

    Published on 5/10/2004
  • Sending signals

    Sending signals It is widely accepted that the use of EPO to treat anemia reduces fatigue and improves quality of life in cancer patients. But the results of two placebo-controlled studies indicate that use of EPO as…

    Published on 5/10/2004
  • Tag team wrestling

    Increased collaboration between FDA and SEC, fallout from the ImClone Systems Inc. case, …

    Published on 4/26/2004
  • ABCs of the FDA-SEC MOU

    The FDA-SEC memorandum of understanding (MOU) primarily involves referrals …

    Published on 4/26/2004
  • Genentech's shot at biogenerics

    Genentech Inc. has renewed the biotech industry's efforts to preempt FDA's creation of a pathway for the approval of biogenerics. The …

    Published on 4/19/2004
  • Approval queue

    Cover Story: Regulation: Gone, but not gone Approval queue Selected drugs under review during changing of the guard at FDA. (A) PDUFA date estimated based on the company's announcement that the NDA was submitted for…

    Published on 2/23/2004
  • Clearing the backlog

    Cover Story: Regulation: Gone, but not gone Clearing the backlog During the Mark McClellan era, the agency approved 11 of the backlog of 24 selected high-profile compounds that had been held in limbo during the 20 …

    Published on 2/23/2004
  • Gone, but not gone

    Clearing the backlog McClellan's waiting list Approval queue Gone, But not Gone: The Street: Probably more gained than lost President Bush's …

    Published on 2/23/2004
  • The Street: Probably more gained than lost

    Cover Story: Regulation: Gone, but not gone Gone, But not Gone The Street: Probably more gained than lost By Eric Pierce Senior editor The stock market took a reflexive dip on Friday following the Bush …

    Published on 2/23/2004
  • McClellan's waiting list

    Cover Story: Regulation: Gone, but not gone McClellan's waiting list Selected products delayed by FDA actions during McClellan's tenure. (A) TKTX later withdrew application as a result of Genzyme's orphan …

    Published on 2/23/2004
  • FDA timetable for biogenerics framework

    FDA is developing a scientific framework for the regulation of follow-on biologics and expects to release a draft for public …

    Published on 1/19/2004
  • 2003 timelines

    Regulation: PDUFA: Time stands still 2003 timelines The progress of selected drugs approved by one of CDER's 15 review divisions and by CBER through Sept. 30, 2003. Where action dates are included in place of cycle …

    Published on 12/8/2003
  • PDUFA: Time stands still

    Ranking the divisions Second-cycle outcomes 2003 timelines Time Stands Still: PDUFA terminology Despite the promise of the …

    Published on 12/8/2003
  • Ranking the divisions

    Regulation: PDUFA: Time stands still Ranking the divisions The progress of every drug approved by each of the Center for Drug Evaluation and Research's 15 review divisions and by the Center for Biologics Evaluation …

    Published on 12/8/2003
  • Second-cycle outcomes

    Regulation: PDUFA: Time stands still Second-cycle outcomes The progress of new chemical entities (NMEs) resubmitted for a second-cycle review from 1998 to Aug. 31, 2003. One-third of the approvable letters issued …

    Published on 12/8/2003
  • PDUFA terminology

    Cover Story: Regulation: PDUFA: Time stands still Time Stands Still PDUFA terminology Under the terms of the Prescription Drug User Fee Act, FDA seeks to complete standard reviews of drugs and biologics within 10 …

    Published on 12/8/2003
  • Deconstructing OPPS

    Regulation Deconstructing OPPS On Jan. 1, the Centers for Medicare & Medicaid Services (CMS) implemented a new reimbursement system for drugs provided by hospitals in outpatient settings. The Outpatient Prospective …

    Published on 11/10/2003
  • EPO equivalence: The sequel

    Regulation EPO equivalence: The sequel In its final hospital outpatient prospective payment system (OPPS) rule for 2004, the Centers for Medicare and Medicaid Services (CMS) refined its take on the so-called "…

    Published on 11/10/2003
  • Reddy or not

    FDA has announced approval of a new calcium channel blocker product that could, if it withstands legal challenges, set a precedent for a new type of assault…

    Published on 11/10/2003

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993