BiologicDrugReport
Biologic Drug Report
Your INDEPENDENT source of news about biologic drugs
 
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Biologic Drug Report - News About Biologics
 

Biologic drugs are produced from living cell cultures rather than synthesized chemically. Many of these "biologics" offer hope to people who have had no success with other drugs. Beyond the biologics already in use, hundreds are in clinical trials -- with many expected to make it to market in the next few years.

Biologic drugs, which tend to be very expensive, already account for almost one-fifth of all dollars spent on drugs in the United States, and the total is expected to rise to one dollar in four by 2008.

A big part of the cost lies in development and manufacture of these complex biotech drugs. And for most biologics, there are as of yet no generics.

Many biologics also have to be taken by injection or intravenous infusion in a doctor's office -- and in some cases, the manner in which physicians are reimbursed for the drugs they buy and administer provides them with an incentive to prescribe higher-cost biologics.

With biologics carving out an increasingly important role in medical care, Biologic Drug Report will be your independent source of news and information on the new biologics available -- and efforts to keep them affordable.

  Biologic Drug News for November 2007 -- News About Biologics
  Biologic Drug Avastin Slows Spread of Brain Cancer in Phase II Study
Biologic Erbitux First to Extend Survival for Colorectal Cancer Patients
FDA Approves Anemic Biologic Mircera, But No Early U.S. Launch Expected
Warning Labels Strengthened on Biologic Drugs Used to Treat Anemia
  Biologic Drug News for October 2007 -- News About Biologics
  Biologic Drug Alemtuzumab Seen Promising for Treating Multiple Sclerosis
Biogen Idec to Explore Possible Sale of Company
Genentech Tries to Keep Avastin From Use in Place of Lucentis for Eyes
New Biologic Drug Ustekinumab Shows Promise for Treating Psoriasis
  Biologic Drug News for September 2007 -- News About Biologics
  Medicare Affirms Anemia Drug Limits Unless New Evidence Is Submitted
Hopes for Enactment of Follow-on Biologics Legislation Vanish for 2007
FDA Panel to Weigh in on Dosing of Anemia Biologics for Kidney Patients
House Members: Outlook for Generic Biologics in FDA Bill 'Extremely Slim
Study: Anemia Biologic May Reduce Mortality Among Trauma Patients
Senate Urges Medicare to Review Policy Limiting Use of Anemia Biologics
  Biologic Drug News for August 2007 -- News About Biologics
  Roche Plans to Launch Anemia Drug Micera in U.S. Despite Court Setback
NICE Recommends Making Three Biologics Available to Patients in U.K.
Amgen. Leading Seller of Biologics, Cutting Jobs in Major Restructuring
FDA Advisory Panels Recommend Use of Biologic Tysabri to Treat Crohn's
  Biologic Drug News for July 2007 -- News About Biologics
  Medicare Eases Curbs on Use of Biologics to Treat Cancer-Related Anemia
Biologic Mircera Gets Green Light for Immediate Launch in U.K., Germany
Biologics for Treating IBD 'Provide Hope' for Patients, But Caution Urged
House Members Urge Keeping Follow-on Biologics Out of Drug Safety Bill
Medicare Tightens Use of Anemia Drugs for Kidney Dialysis Patients
Only One Novel Biologic Drug Approved by FDA in First Half of 2007
Prospects for Early Action on Follow-on Biologics Dim After Safety Bill Vote
Arthritis Biologic Drug Actemra Meets Goals in Late-Stage Clinical Trial
Competition Among MS Biologics Heats Up With Innovative Payment Twist
  Biologic Drug News for June 2007 -- News About Biologics
  Follow-on Biologics Compromise Passes First Test in U.S. Senate
Big Dialysis Chains Pad Profits on Medicare Reimbursement for Epogen
Novel Reimbursement Approach Unveiled to Hold Down Biologic Spend
Follow-on Biologics Get Major U.S. Boost With Senate Compromise
Three Anemia Biosimilars Are Approved for Sale in Europe
Compromise on Follow-on Biologics Seen Inevitable But Still Elusive
Regeneron Completes FDA Biologics Application for Interleukin-1 Trap
Biologic Remicade Approved for Pediatric Crohn's Disease in Europe
Biologic Drug Humira Approved in Europe for Treating Crohn's Disease
Doctors Show Little Concern Over Approved Uses of Biologics for Anemia
  Biologic Drug News for May 2007 -- News About Biologics
  FDA Slows Approval Process for Cervical Cancer Vaccine Cervarix
European Experts Reject Biologic Cancer Drug Vectibix; Amgen to Appeal
Biologic Mircera Approved in Europe for Kidney Patients With Anemia
Moderate Democrats Back Inslee Approach to 'Follow-on Biologics'
Amgen Gets NY State Subpoena Related to Promotions for Biologics
Biologic Anemia Drug Mircera Again Delayed by U.S. FDA
Supreme Court Declines to Hear Appeal in Patent Fight Over Epogen
Medicare Proposes Limiting Payments for Anemia Drugs Used in Cancer
New Limits on Anemia Biologic Drugs Recommended by FDA Panel
New Allegations About Anemia Drug Rebates Appear in Wall Street Journal
FDA Indefinitely Delays Approval of Therapeutic Cancer Vaccine Provenge
Biologics Provide Millions in Extra Profits for Doctors -- New York Times
Follow-on Biologics Bill to Be Acted on By Senate Panel on June 13th
White House Opposes Effort to Speed Generic Biologics Legislation
Reimbursement Incentives May Hold Key to Cost Savings on Biologics
  Biologic Drug News for April 2007 -- News About Biologics
  Hatch: Compromise Efforts on Generic Biologics Legislation Moving Slowly
Key Decision on Generic Biologics Legislation Expected This Week
Biotech MedImmune to Be Acquired by AstraZeneca
Alternative to Generic Biologics Bill Introduced in U.S. House
Biologic Aranesp Falls Short in Trial But Does Not Increase Risk of Death
JAMA Editorial Raps For-Profit Dialysis Centers on Dosing of Epogen
Generic Biologics Still Not in Big FDA Bill, But Kennedy Holds Out Hope
Hopes for Speedy Action on Generic Biologics Bill Fade in U.S. Senate
Biotech MedImmune Hires Goldman Sachs to Explore Possible Sale
Biologic Drug Erbitux Proves Disappointing as Pancreatic Cancer Therapy
Lawmakers Reported 'Working Feverishly' on Generic Biologics Legislation
Biologic to Prevent Hepatitis B After Liver Transplant Approved by FDA
Roche Buys Small Biologics Company for $56.5 Million
Glaxo Seeks FDA Approval of Cervical Cancer Vaccine Cervarix
  Biologic Drug News for March 2007 -- News About Biologics
  Biologic Drug Ceprotin Approved for Treating Rare Clotting Disorder
Biologic Provenge Gets FDA Panel's Backing as Prostate Cancer Treatment
Follow-on Biologics Will Require More Safety and Effectiveness Data -- FDA
Tension Over 'Buy-and-Bill' Reimbursement for Biologics Back in Headlines
Global Biotech Drug Market Grows by 17.9 Percent in 2006
UCB to Launch New Trial of Biologic Drug Cimzia for Crohn's Disease
Amgen Halts Trial of Biologic Vectibix for Colorectal Cancer, Citing Safety
Key Lawmaker Calls for Halt to 'Physician Incentives' for Anemia Biologics
Influential Kidney Doctor's Ties to Amgen Examined in New York Times
Biologic Drug Soliris Approved by FDA for Treating Rare Blood Disorder
FDA Chief Says Biosimilars Not Interchangeable for Brand-Name Biologics
Biosimilars Seen Producing Far Smaller Savings Than Earlier Projections
Medicare Reviewing Policies Related to Biologic Anemia Drugs
Analysis: Payment System Has Role in Overly Aggressive Anemia Drug Use
FDA Issues New Warning on Biologic Drugs Used to Treat Anemia
Generic Biologics Draw Words of Caution From Europe at Senate Hearing
Spray Version of Biologic Drug rhThrombin Will Not Require New Trials
Senate Panel to Open Hearings on Generic Biologic Drugs
Views Differ on Outlook for Bid to Enable FDA Approval of Biosimilars
Medicare Panel Urges Reimbursement Change to Help Curb Biologic Costs
  Biologic Drug News for February 2007 -- News About Biologics
  Amgen Says SEC Looking at Release of Data on Study of Biologic Aranesp
Biologic Humira Approved by FDA for Treatment of Crohn's Disease
FDA Advisory Panel Recommends Approval of First Bird Flu Vaccine
Biologic Cancer Drugs Fastest Growing Class of Biologics in 2006
Roche Halts Enrollment in Study of Biologic Cera Due to Safety Concerns
Studies Projecting Huge Savings from Generic Biologics Termed 'Flawed'
Low-Dose of Biologic Cancer Drug Avastin Works as Well as Higher Dose
Dialysis Centers Probed on Medicare Claims for Anemia Drug Epogen
Biologics Patent Related to Monoclonal Antibodies Ruled Invalid
FDA Orders Stronger Warning for Biologic Asthma Drug Xolair
PBM Exec Says Generic Biologics Needed to Control Soaring Costs
Insurer Ordered to Pay $40,000 for 'Off-Label' Use of Biologic Drug Rituxan
Amgen Under Fire for Failure to Disclose New Aranesp Safety Concerns
Hearing Put Off in Battle Between Makers of Biologics Iplex and Increlex
Generic Biologics Could Save Payers $71 Billion Over a Decade: Study
Generic Biologics Legislation Again Introduced in Congress
Generic Biologics Legislation Set for Introduction in Congress on Feb. 14th
Tension Over Biologic Reimbursement Hits Headlines With Gardasil
Biologic Remicade Data Offers 'Great Hope' to Severe Psoriasis Patients
UCB Plans to Meet With FDA Within Month on Biologic Cimzia
Biologic Drug Humira Psoriasis Trial Provides Encouraging Results
Survey: Most Moderate to Severe Psoriasis Patients Not Receiving Biologics
Biologic Drug Raptiva Effective in Treating Psoriasis of Hands and Feet
FDA Approves Marketing Biologic Alphanate for von Willebrand Disease
  Biologic Drug News for January 2007 -- News About Biologics
  Reimbursement Curbs Seen Limiting Use of Biologics for Crohn's Disease
Genentech: Biologic Eye Drug Lucentis Ups Stroke Risk in Elderly Patients
'Increased Risk of Death' for Some Cancer Patients Treated With Aranesp
FDA Panel Recommends Approval of Sanofi Combo Vaccine for Infants
Cost, Reimbursement Issues Seen Dampening Use of Biologics for Psoriasis
FDA Panel to Weigh Whether Sanofi Combo Vaccine Should be Used in US
Analyst Suggests That Roche's Anemia Biosimilar May Prove Too Similar
Study: Biologic Avastin and Chemo Help With Advanced Colorectal Cancer
Cervical Cancer Vaccine Cervarix Pitted Against Gardasil in Clinical Trial
Biologic Provenge Put on Fast Track by FDA for Advanced Prostate Cancer
Europe Grants Orphan Drug Status to Biologic Prochymal for GVHD
Study: No Evidence Human Growth Hormone Is the Fountain of Youth
Novo Nordisk to Focus All Future R&D Activities on Biologic Drugs
Natural Hormone Secreted in Gut Funded in UK as Potential Obesity Drug
11 State Governors Urge FDA to Easy Way for Generic Versions of Insulin
Intellect Neurosciences Buys Two Biologics for Treatment of Alzheimer's
Trial Shows Erbitux Plus Chemo Is Better Colorectal Cancer Treatment
Supreme Court Rules for MedImmune in Patent Dispute Over Synagis
Genentech, Seattle Genetics in Pact for Promising Cancer Biologic SGN-40
Promising Approach Reported to Delivering Insulin, Other Biologics Orally
Serono Joins With Merck KGaA and Becomes Merck Serono
Biologic Prochymal Put on Fast Track for Treatment of Crohn's Disease
Imclone Planning to Release New Study on Erbitux for Colorectal Cancer
Analysis Finds 'Biogenerics' Could Save Medicare $14 Billion Over a Decade
Biogen Idec to Acquire Syntonix and Hemophilia Products in Development
Hopes for Anti-Inflammatory Biologic Dim After Disappointing Heart Trial
 
Biologic Drug Report

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This is an independent news site reporting on Biologic Drugs. Nothing on this site is intended as medical advice. The information provided here is for informational purposes only. Always consult a doctor or medical professional with questions you may have regarding a medical condition.

Last Updated: 11/18/2007

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