FDA News, p.2

Mon Aug 30 17:48:07 2010
(Bionovo, Inc.)
Bionovo Receives Positive Guidance from FDA on Menerba®

Mon Aug 30 06:24:06 2010
(BioMarin Pharmaceutical Inc.)
BioMarin Receives Orphan Drug Designation from the FDA for BMN-701 for the Treatment of Pompe Disease

Fri Aug 27 06:12:06 2010
(Novartis Pharmaceuticals Corporation)
Novartis receives FDA approval of Tekamlo™, a single-pill combination of aliskiren and amlodipine to treat high blood pressure

Tue Aug 24 09:48:09 2010
(Shire plc)
Pentasa(R) - Shire Receives Ruling From FDA on Citizen's Petition

Tue Aug 24 09:45:06 2010
(Yahoo AP)
Johnson & Johnson gets FDA warning on marketing

Mon Aug 23 05:18:03 2010
(Soligenix, Inc.)
Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant

Thu Aug 19 15:48:25 2010
(Eli Lilly and Company)
Statement from Eli Lilly and Company Regarding Approval Recommendation from FDA Advisory Committee for Expanding the Pain Indications for Cymbalta® to a Broader Pain Population

Wed Aug 11 14:00:08 2010
(GlaxoSmithKline)
Ezogabine, an Investigational Anti-Epileptic Drug, Receives Positive Vote From FDA Advisory Committee

Mon Aug 9 08:48:05 2010
(Pfizer Inc.)
Pfizer Receives FDA Approval for Prefilled Dual-Chamber Syringe for Use in the Treatment of Hemophilia A

Mon Aug 9 03:06:18 2010
(Regenerative Sciences, Inc.)
Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court

Fri Aug 6 10:30:14 2010
(DUSA Pharmaceuticals, Inc.)
DUSA Pharmaceuticals Receives Response From FDA on Orphan Drug Designation Status

Wed Jul 28 13:43:16 2010
(Abbott)
Abbott's SIMCOR ® ( niacin extended-release / simvastatin ) Receives FDA Approval for New Dosage Strengths

Wed Jul 28 02:18:15 2010
(EMD Serono, Inc.)
EMD Serono, Inc.: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of MS

Mon Jul 26 12:18:12 2010
(Roche Diagnostics)
Roche Receives FDA Clearance for CoaguChek XS Pro system With Bar Code Reader for PT/INR Testing at the Point of Care

Mon Jul 26 04:33:08 2010
(TheStreet)
Onyx Eyes FDA Filing for Blood Cancer Drug

Fri Jul 16 11:00:19 2010
(American Clinical Laboratory Association)
Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests

Thu Jul 15 16:00:07 2010
(VIVUS, Inc.)
VIVUS Comments on FDA Advisory Committee Panel Meeting on QNEXA® (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity

Thu Jul 15 08:24:11 2010
(Agendia B.V.)
Agendia to Provide Testimony at Public Meeting on FDA Oversight of Laboratory-Developed Tests

Wed Jul 14 17:12:31 2010
(Takeda Pharmaceuticals North America, Inc.)
Takeda Responds to FDA Advisory Committee Recommendation

Tue Jul 13 09:18:01 2010
(AP Health)
Vivus weight loss drug faces FDA panel this week

Thu Jul 8 03:30:15 2010
(Kiadis Pharma)
Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States

Thu Jul 1 13:48:03 2010
(Purdue Pharma, LP)
Purdue Pharma L.P. Receives FDA Approval for Butrans™ (buprenorphine) Transdermal System CIII

Thu Jul 1 10:00:11 2010
(Lupin Pharmaceuticals, Inc.)
Lupin Receives FDA Approval for Famotidine for Oral Suspension

Thu Jul 1 00:30:11 2010
(Arena Pharmaceuticals, Inc.)
Eisai to Market Arena Pharmaceuticals' Lorcaserin for Obesity and Weight Management in U.S. Following FDA Approval

Tue Jun 29 04:45:03 2010
(Yahoo AP)
Teva says FDA approved its generic Effexor XR

Tue Jun 29 04:39:10 2010
(TheStreet)
Teva Gets FDA OK for Generic Effexor XR

Mon Jun 28 07:54:06 2010
(Tarix Pharmaceuticals)
Tarix Pharmaceuticals' TXA127 Receives FDA Orphan Drug Designation for Stem Cell Engraftment

Fri Jun 18 08:27:02 2010
(Yahoo AP)
Mylan receives FDA OK for generic version of Zocor

Thu Jun 17 11:33:11 2010
(Yahoo AP)
Mylan says FDA clears generic version of Atarax

Thu Jun 17 05:51:13 2010
(Yahoo AP)
Orexigen says FDA sets Jan. 31 date for Contrave

Wed Jun 16 12:48:12 2010
(SanBio Inc.)
SanBio Receives FDA Clearance to Initiate Cell Therapy Clinical Studies for Stroke Recovery

Thu Jun 10 08:36:13 2010
(Star Scientific, Inc.)
Star Scientific, Rock Creek Pharmaceuticals Present at FDA Advisory Subcommittee Meeting

Thu Jun 3 05:36:16 2010
(Abbott)
Abbott Receives FDA Clearance for New Ovarian Cancer Test

Thu May 27 23:30:11 2010
(Roche Diagnostics Corporation)
Roche Diagnostics Receives FDA Approval for Qualitative Anti-HCV Immunoassay Test on Three Analyzer Platforms

Thu May 27 04:30:06 2010
(Repligen Corporation)
Repligen Announces FDA and EMA Approval of Re-analysis of Images from Phase 3 Trial of RG1068 for Pancreatic Imaging

Wed May 26 05:39:05 2010
(Yahoo AP)
Mylan says FDA approves generic herpes drug

Tue May 25 10:39:06 2010
(Yahoo AP)
Genzyme gets FDA approval for Lumizyme

Tue May 25 08:39:12 2010
(TheStreet)
Genzyme's Lumizyme Receives FDA Approval

Mon May 24 08:06:05 2010
(Repligen Corporation)
Repligen Receives Orphan Drug Designation from the FDA for RG2833 for Friedreich's Ataxia

Fri May 14 14:24:10 2010
(Amgen Inc.)
Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients

Thu May 6 08:45:01 2010
(Yahoo AP)
Amylin faces Oct. 22 FDA review for Bydureon drug

Thu May 6 05:01:40 2010
(AETERNA ZENTARIS INC.)
Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer

Mon May 3 14:18:02 2010
(Questcor Pharmaceuticals, Inc.)
Questcor to Discuss Results From FDA Panel Meeting

Thu Apr 29 11:21:13 2010
(TheStreet)
Dendreon Receives FDA Approval for Provenge

Thu Apr 22 14:13:00 2010
(Amylin; Lilly; Alkermes)
Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

Thu Apr 22 14:12:51 2010
(King Pharmaceuticals, Inc.; Acura Pharmaceuticals, Inc.)
Acura Pharmaceuticals and King Pharmaceuticals Provide Update on FDA Advisory Committee Meeting For Acurox(R)

Thu Apr 22 06:27:03 2010
(TheStreet)
Acura Pharma: FDA Panel Live Blog

Wed Apr 21 23:00:16 2010
(Novartis)
Novartis Receives US FDA Approval for Zortress(R) (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients

Tue Apr 20 12:39:09 2010
(TheStreet)
Acura Pharma FDA Panel Preview: Updated

Tue Apr 20 10:54:03 2010
(Lupin Pharmaceuticals, Inc.)
Lupin Receives FDA Approval for Imipramine Pamoate Capsules

Mon Apr 19 23:21:15 2010
(TheStreet)
Acura Pharma FDA Panel Preview

Mon Apr 19 06:24:03 2010
(CSL Behring)
CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen(R) from 24 to 36 Months

Mon Apr 12 09:03:11 2010
(Yahoo AP)
Mylan gets FDA OK for generic blood pressure drug

Thu Apr 8 23:24:16 2010
(Cell Therapeutics, Inc.)
CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Wed Apr 7 03:33:08 2010
(TheStreet)
14 Biotech Stocks Facing FDA Approval

Mon Apr 5 07:57:08 2010
(Yahoo AP)
Keryx cancer treatment gets faster FDA review

Mon Apr 5 06:06:22 2010
(AETERNA ZENTARIS INC.)
Æterna Zentaris Announces Perifosine Receives FDA Fast Track Designation for the Treatment of Refractory Advanced Colorectal Cancer

Mon Apr 5 06:06:07 2010
(Keryx Biopharmaceuticals, Inc.)
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer

Mon Mar 22 18:45:10 2010
(PRISYM ID)
PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance

Mon Mar 22 10:57:13 2010
(Cell Therapeutics, Inc.)
CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Mon Mar 22 10:57:09 2010
(Lupin Pharmaceuticals, Inc.)
Lupin Receives FDA Tentative Approval for Eszopiclone Tablets

Mon Mar 22 04:54:16 2010
(TheStreet)
Cell Therapeutics' FDA Panel: Live Blog

Fri Mar 19 08:45:12 2010
(Yahoo AP)
A.P. says FDA asks more about drug, shares halved

Fri Mar 19 01:03:16 2010
(Stemedica Cell Technologies, Inc.)
Stemedica Files IND Application With FDA for Treatment of Stroke With Adult Allogeneic Mesenchymal Stem Cells

Mon Mar 15 17:00:06 2010
(Yahoo AP)
Watson generic hypertension drug gets FDA approval

Mon Mar 15 11:03:06 2010
(TheStreet)
Questioning MannKind's FDA Delay: BioBuzz

Mon Mar 15 03:27:19 2010
(Amylin Pharmaceuticals, Inc.)
Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission

Fri Mar 12 04:09:11 2010
(Yahoo AP)
Eisai says FDA approved new Dacogen dosing

Wed Mar 10 13:15:07 2010
(Dainippon Sumitomo Pharma America, Inc.)
Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia

Tue Mar 9 13:39:09 2010
(TheStreet)
InterMune's Wins Positive Vote on FDA Panel: Live Blog (Update 11)

Tue Mar 9 11:48:04 2010
(Yahoo AP)
InterMune shares halted ahead of FDA panel

Tue Mar 9 07:48:21 2010
(TheStreet)
InterMune's FDA Panel: Live Blog (Update 4)

Tue Mar 9 05:51:12 2010
(TheStreet)
InterMune's FDA Panel: Live Blog (Updated)

Fri Mar 5 08:21:13 2010
(Yahoo AP)
Intermune shares surge as FDA reviews lung drug

Fri Mar 5 08:15:10 2010
(TheStreet)
InterMune Surges on FDA Drug Review

Fri Mar 5 04:33:18 2010
(InterMune, Inc.)
InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone

Tue Mar 2 06:09:13 2010
(TheStreet)
Report Claims Dendreon Facing FDA Panel: BioBuzz

Mon Mar 1 08:42:13 2010
(TheStreet)
New FDA Date for Cell Therapeutics: BioBuzz

Fri Jan 22 15:54:07 2010
(TheStreet)
Acorda Spikes on FDA Approval for MS Drug

Mon Dec 14 14:36:08 2009
(TheStreet)
Biotech Calendar: Upcoming FDA Dates

Thu Dec 3 08:15:07 2009
(Reuters)
UPDATE 1-Genzyme, FDA agree a pathway for Lumizyme approval

Wed Dec 2 08:51:08 2009
(Reuters)
UPDATE 1-Dyax shrs soar after FDA approves genetic-disorder drug

Wed Dec 2 06:54:08 2009
(Reuters)
UPDATE 1-CytRx says FDA lifts clinical hold on Lou Gehrig's drug

Tue Dec 1 22:24:15 2009
(TheStreet)
Hemispherx's Ampligen Dealt FDA Blow

Tue Dec 1 17:15:08 2009
(Reuters)
UPDATE 1-Dyax gets FDA marketing nod on genetic disease drug

Tue Dec 1 09:27:10 2009
(Reuters)
UPDATE 1-Teva seeks FDA nod for biosimilar of Amgen drug

Fri Nov 20 03:39:12 2009
(TheStreet)
Biotech Stock Mailbag: FDA Playbook

Mon Nov 16 14:33:09 2009
(Reuters)
UPDATE 2-US FDA wants panel to probe Pfizer vaccine efficacy

Mon Nov 16 08:42:08 2009
(Reuters)
UPDATE 1-Genzyme says FDA declines to approve Pompe disease drug

Mon Nov 16 06:45:18 2009
(Reuters)
UPDATE 1-Par Pharma gets FDA nod for generic version of Ultram

Fri Nov 13 14:27:08 2009
(Reuters)
UPDATE 1-US FDA warns Shire, Eisai on promotions

Mon Nov 2 13:15:27 2009
(Reuters)
UPDATE 1-US FDA issues alert on kidney problems with Byetta

Fri Oct 30 19:57:26 2009
(Reuters)
UPDATE 1-Amylin says Byetta gets FDA approval for new use

Fri Oct 30 12:09:18 2009
(Reuters)
UPDATE 2-Geron, FDA agree on spinal injury drug trial

Tue Oct 27 00:18:09 2009
(Reuters)
Genmab says gets FDA approval for Arzerra

Mon Oct 26 12:36:12 2009
(Reuters)
UPDATE 2-US FDA questions Human Genome anthrax drug data

Sun Oct 25 22:51:07 2009
(AP Health)
GAO: FDA fails to follow up on unproven drugs

Wed Oct 21 15:36:21 2009
(Reuters)
UPDATE 4-Amgen Q3 profit beats but FDA concern hits shares

Thu Oct 15 09:27:12 2009
(Reuters)
UPDATE 1-Acorda shares soar after FDA panel backs MS drug

Wed Oct 14 15:54:07 2009
(Reuters)
U.S. FDA panel supports Acorda MS drug