Pegloticase BLA Filing Accepted for Priority Review by FDA

Application for Treatment-Failure Gout Granted Priority Review EAST BRUNSWICK, N.J., Dec. 29 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Appli...

Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA

MONTVALE, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA). Thes...

Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)

...iencies with the chemistry, manufacturing and controls (CMC) section of the bla and also provided the current draft of the proposed labeling and further gu...ted to, the possibility that the FDA may raise further issues regarding the bla for KRYSTEXXA or require that we conduct additional clinical trials, our ab...

Human Genome Sciences Announces Second-Quarter 2009 Financial Results and Key Developments

...venue Expected over Three-Year Period; Raxibacumab bla to Receive Priority FDA Review; Data Supporting bla Published in New England Journal of Medicine ...hrax. In July 2009, the FDA notified HGS that the bla for raxibacumab has been filed and will receive pr...

FDA Extends Review Timeline for STELARA(TM) (ustekinumab) Biologic License Application by Three Months

...l date, pertains to testing results to establish the product's shelf life. The FDA has requested no additional clinical trials for STELARA. The U.S. bla extension does not affect the approval or marketing of STELARA in Europe or Canada, nor does it apply to pending applications in other markets. "...

Savient Pharmaceuticals to Present at The Cowen and Company 29th Annual Healthcare Conference on March 17, 2009

... clinical studies began in June 2006; patient enrollment was completed in March 2007; the Phase 3 clinical studies were completed in October 2007; the bla was filed with the FDA in October 2008 and the FDA granted priority review status in December 2008. Savient has exclusively licensed worldwide rights...

Savient Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results

...A) in October 2008. FDA agreed to file our bla application and granted a priority review at the e...s designed to strengthen and clarify the KRYSTEXXA bla were filed and deemed a major amendment by the FDA... a pivotal one for the Company as we submitted our bla to the FDA for KRYSTEXXA, our product for treatmen...

GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

...e still having to cope with adverse effects.(4) "The submission of the bla for ofatumumab brings us closer to the possibility of providing a new treat...a N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "This is the first bla ever filed for an antibody produced by Genmab and is a significant achievem...

Savient Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference on January 14th

...al studies began in June 2006; patient enrollment was completed in March 2007; and the Phase 3 clinical studies were completed in October 2007 and the bla was filed with the FDA in October 2008. Savient has exclusively licensed worldwide rights to the technology related to pegloticase, formerly referred...

ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema

...e results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental bla as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the ...

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bla in Medical Technology

CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema

Pivotal phase II/III study demonstrates C1-INH is effective treatment for acute HAE attacks KING OF PRUSSIA, Pa., March 6 /PRNewswire/ -- CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval ...

BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health

NOVATO, Calif., Aug. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has submitted a Biologics License Application (BLA) for Naglazyme(R) (galsulfase) to the Ja...

Savient Provides Update on Pegloticase BLA

Company Files Amendments to Strengthen and Clarify BLA Data FDA Extends PDUFA Action Date to July 30, 2009 Company to Host Conference Call EAST BRUNSWICK, N.J., Feb. 12 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that the Company f...

Scientific Data Relating to Cinryze(TM) Presented at 6th Annual C1 Inhibitor Deficiency Workshop

...e results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental bla as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the ...

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)

...m.com/cgi-bin/prnh/20080416/HGSLOGO ) The bla submission includes the results of two randomized ...atory Affairs, HGS. "In addition, the raxibacumab bla is the first HGS has submitted, so it represents a...acumab revenue in the second quarter of 2009. The bla is also being filed under the BARDA contract, and ...

Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review

...old/Wrinkles product candidate and that the FDA has accepted (or filed) the bla for full review. In a communication received from the FDA on May 7, 20...09, the FDA noted that it had completed its initial review of the Company's bla to determine its acceptability for filing and that the FDA has filed the Co...

Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

... trials were conducted under an FDA Special Protocol Assessment. "This bla submission is a significant regulatory milestone for Isolagen," said Declan...ted efforts." Mr. Daly continued, "In addition to submitting our first bla to the FDA, the Company has recently completed its Phase II/III trial for t...

FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

...e results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental bla as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the ...

Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients

... therapeutic class. Savient submitted its bla to the FDA on October 31, 2008 seeking approval to...s. On December 29, 2008, the FDA accepted the bla filing for review and granted priority review. A ...target date for an FDA decision on the pegloticase bla is April 30, 2009. Savient's filing includes ...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)

... new therapy available to patients with RA." Roche submitted the bla for ACTEMRA to the FDA on November 18, 2007. The bla for ACTEMRA is based on the results of an extensive multi-national clinical...

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bla in Biological Technology

Human Genome Sciences Announces New Order for Raxibacumab (ABthrax(TM)) from U.S. Government

...) to the U.S. Food and Drug Administration (FDA) for raxibacumab for the treatment of inhalation anthrax. In July 2009, the FDA notified HGS that the bla for raxibacumab has been filed and will receive priority review. HGS will receive $10 million from the U.S. Government upon FDA licensure of raxibacu...

Data Published in The New England Journal of Medicine Support Use of Raxibacumab (ABthrax(TM)) for the Treatment of Inhalation Anthrax

...tted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for raxibacumab for the treatment of inhalation anthrax. The bla was also filed under the BARDA contract, and HGS will receive $10 million from the U.S. Government upon FDA licensure of raxibacumab. About Anth...

Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August

...quently fracture. We look forward to discussing the data from our denosumab trials in these settings with the members of the Committee." Amgen's bla submission contains data from six Phase 3 trials involving more than 11,000 patients and approximately 13,000 patient years of exposure to denosumab. ...

FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout

...ments regarding the efficacy and safety of KRYSTEXXA(TM) (pegloticase), our bla filing with the FDA, the Advisory Committee, approval of the BLA, preparati...e, but are not limited to, the possibility that the FDA may not approve our bla for KRYSTEXXA, notwithstanding the recommendation of the Advisory Committee...

New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease

... Wyeth submitted a Biologic License Application (BLA) for Prevenar 13 to the U.S. Food and Drug Administration (FDA). Last month, the FDA granted the bla priority review -- a designation given to products that, if approved, would be a significant therapeutic or public health advance. Prevenar 13 is als...

ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

... The Company is evaluating the complete response letter from the FDA and there can be no assurance that the Company will either amend its supplemental bla or conduct future clinical studies with Cinryze as a treatment for acute attacks of hereditary angioedema. In the event the Company does conduct add...

ViroPharma Incorporated Honored by the National Organization for Rare Disorders

...e results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental bla as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the ...

BioSpecifics Technologies Corp. Reports First Quarter 2009 Financial Results

...ean marketing agreement with Pfizer as well as the bla Priority Review acceptance for Dupuytren's disease...9, the FDA accepted for Priority Review Auxilium's bla for XIAFLEX(TM) for the treatment of Dupuytren's disease. Auxilium filed the bla on February 27, 2009 and included data from 1,082 ...

Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

... In December, the FDA accepted the Company's bla for KRYSTEXXA and granted priority review status, ...o the FDA several key amendments for the KRYSTEXXA bla to further strengthen and clarify the overall bla application. The FDA reviewed and accepted the ame...

Savient Pharmaceuticals Reports First Quarter 2009 Financial Results

...ata included in our previously submitted BLA. The bla priority review Prescription Drug User Fee Act (PD...d major amendments, accepted the amendments to the bla and elected to extend the current review period an...inical studies were completed in October 2007; the bla was filed with the FDA in October 2008 and the FDA...

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