FDA
Sponsored by: SCOTTRADE: Start trading for just $7
Set Up E-mail Alerts For FDA » RSS Feed For FDA »Covidien (NYSE: COV) announced that Health Canada has approved the Company's Abbreviated New Drug Submission (ANDS) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's generic product is fully substitutable for Cardiolite(R), a myocardial perfusion imaging agent used for detecting coronary artery disease.
With Health Canada approval of the ANDS, which was filed by the Company's Canadian subsidiary, Covidien's generic product is expected to be available for customers in Canada this summer. The Company's generic product also is available in the U.S., the U.K., Denmark, Germany and Puerto Rico.
CombinatoRx, Incorporated (NASDAQ: CRXX) \announced the advance online publication by CombinatoRx scientists of an extensive analysis of their discovery screening, scheduled to appear in the August issue of Nature Biotechnology. These new findings provide evidence that multi-target synergistic combinations may be more therapeutically specific than single agents.
By performing a comprehensive synergy analysis across pairs of assays covering six different disease areas and ~100,000 combinations, CombinatoRx scientists have empirically shown that synergistic combinations may yield greater therapeutic selectivity than single drugs. Therapeutic selectivity occurs when a treatment has more beneficial than toxic effect. Additional preclinical analysis by the authors on sample combinations shows that this selectivity results from coordinated context-specific multi-target activity.
Spectrum Pharmaceuticals (Nasdaq: SPPI) today announced that it has received a Complete Response letter from the U.S. FDA regarding its supplemental Biologics License Application for ZEVALIN(R) (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. The Prescription Drug User Fee Act Action Date for the ZEVALIN sBLA in the first-line consolidation setting was July 2, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. Importantly:
- No additional clinical studies have been requested;
- The additional data requested do not involve new data analyses;
- The Company plans to formally respond to the FDA's requests by this Wednesday, July 8, 2009.
Eli Lilly and Company (NYSE: LLY) announced it received a fourth approval from the FDA for ALIMTA (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.
NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.(1),(2) It is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(3) as well as histologies classified as "other."
Protalix BioTherapeutics, Inc. (NYSE: PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme(R), a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase III clinical trial for the treatment of Gaucher disease.
More FDA
View Older Stories-
ATS Medical (ATSI) Announces FDA Clearance of New ATS Simulus Semi-Rigid Annuloplasty Band
-
Sanofi-aventis (SNY) Announes FDA Approval of Multaq for Patients with Atrial Fibrillation or Atrial Flutter
-
Matrixx Initiatives (MTXX) Bouncing On Reported Positive News-Reuters
-
Johnson & Johnson (JNJ) To Acquire Alzheimer's Assets From Elan (ELN), Invests $1B For 18.4% Stake
-
Acura (ACUR) & King Pharmaceuticals (KG) Receive Complete Response Letter From FDA for Acurox
-
Sepracor (SEPR) Sinks After SEP-22528 Fails To Meet Endpoint and Two Lunesta Studies Put On Hold
-
Pfizer Inc (PFE) Updates U.S. Product Labeling for CHANTIX
-
FDA to Hold Call Discussing Potential Issues with Pfizer's (PFE) Stop-Smoking Drug, Chantix -CNBC
-
Acorda (ACOR) CEO On CNBC
-
Repros Therapeutics (RPRX) Provides Update for Proellex Clinical Program
-
Acorda (ACOR) Enters License Agreement With Biogen Idec (BIIB) For Fampridine-SR Outside the U.S.
-
Pfizer (PFE) Stops Phase 3 Trial of Sutent in Metastatic Colorectal Cancer
-
AMAG Pharmaceuticals (AMAG) Announces FDA Approval of Feraheme
-
FDA Panel Votes 20-17 to Allow Continued Sale of Large Size Bottles of Aspirin, etc -CNBC
-
FDA Panel Votes 21-16 To Recommend Lowering Maximum Daily Dosage of Johnson & Johnson's (JNJ) Tylenol
-
CytRx (CYTR) Files Response to FDA On Partial Clinical Hold On Phase 2b Arimoclomol ALS Trial
-
Medarex (MEDX) Will Receive Milestone Payment from Novartis (NVO) for FDA Approval of Ilaris
-
POZEN (POZN) Submits New Drug Application to FDA for Marketing Approval of VIMOVO
-
AMAG Pharma (AMAG) Expects FDA Action Letter for Feraheme(TM) Injection Within Next Few Days
-
Geron (GERN) In Stem Cell Deal With GE Healthcare
-
Vical (VICL) Said Its H1N1 Vaccine Shows 100% Response In Mice and Rabbits
-
PPD Inc.'s (PPDI) Takeda Pharma Receives FDA Complete Response for Alogiptin
-
PPD (PPDI) Confirms Takeda Receives FDA Complete Response for Alogliptin
-
Medtronic (MDT) Granted 510(k) Clearance by FDA for LUCAS(TM) 2
-
Abraxis BioScience's (ABII) ABRAXANE Approved for Advanced Breast Cancer Patient Treatment in Quebec
-
Sinovac Biotech (SVA) Receives Revised Approval for Panflu
-
Sangamo BioSciences (SGMO) Announced Key Milestone Reached in Cell Engineering Agreement With Genentech
-
ISTA Pharmaceuticals (ISTA) Bepreve Eye Drops Recommended For Approval By FDA Panel
-
Gilead (GILD) Announces European CHMP Adopts Positive Opinion for Aztreonam Lysine
-
FDA Revokes Immucor's (BLUD) Biologics License with Respect to its Reagent Red Blood Cells and Anti-E Blood Grouping Reagent
-
Immucor (BLUD) Said FDA Issues Notice To Revoke License, Company Responds
-
U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical (CPD); FDA Acts to Prevent Repeated Drug Quality Problems
-
Caraco Pharmaceuticals (CPD) Products Seized By FDA
-
CytRx (CYTR) to Present Statistically Significant Evidence of Arimoclomol's Ability to Protect Experimental Animals from Effects of Hypoxia
-
Insmed (INSM) Announces That IPLEX Phase II Trial Did Not Meet A Statistically Significant Improvement
-
Pfizer's (PFE) Sutent Significantly Improved Progression-Free Survival for Patients with Advanced Pancreatic Islet Cell Tumors
-
OraSure (OSUR) Issues Update on Clinical Development Programs and OraQuick Manufacturing
-
Study Shows Medtronic (MDT) Microdebrider Turbinoplasty is a Significantly More Effective, Long-Term Treatment Than Coblation Radiofrequency for Nasal Obstructions
-
Crucell (CRXL) Announces Positive Results of Phase II Rabies Monoclonal Antibody Combination Clinical Study in Philippines
-
Oculus Innovative (OCLS) Confirms Effectiveness of Microcyn Technology at Inactivating the H1NI
-
OncoGenex Pharmaceuticals (OGXI) Completes Amendment to Phase 3 for Confirming Survival Benefit in Patients with First-Line Docetaxel for Metastatic Prostate Cancer
-
Matrixx Initiatives (MTXX) Confirms Voluntary Recall of Zicam
-
Cepheid (CPHD) Noted New England's Journal of Medicine Study Highlights Need for Rapid, PCR-based Group B Streptococcus (GBS) Testing at Time of Admission for Labor and Delivery
-
Cell Therapeutics (CTIC) Submits Ppixantrone NDA to FDA, Requests Priority Review
-
Santarus (SNTS) Reports December '09 Action Date for Schering-Plough's (SGP) OTC ZEGERID NDA
-
Acura Pharma (ACUR) Receives Preliminary Review Letter from FDA Related to NDA for Acurox(r)
-
Spectranetics (SPNC) Announces CE Mark Approval for ThromCatXT
-
China Sky One Medical (CSKI) Obtains Production License Renewal for Sumei Slim Patch
-
Medarex (MEDX) Higher After Experimental Drug Shows Dramatic Results
-
FDA Advises Eurand (EURX) That It Has Extended the Review Period for ZENPEP(TM) Therapy
