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, which includes a database of 250 entries as of 7/9/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI 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. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.

On 7/9/09, Rigel Pharma (NASDAQ:RIGL) announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.

On 7/9/09, GlaxoSmithKline (NYSE:GSK) announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE:MRK) Gardasil.

On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

Disclosure: No positions.

 

On 7/24/09, NeurogesX (NASDAQ:NGSX) announced preliminary results of a short-term clinical study (Study C123) of Qutenza in patients with post-herpetic neuralgia (PHN) following pre-treatment with an FDA approved topical anesthetic. As part of the ongoing new drug application (NDA) review, the FDA requested the study to determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely.

 

NGSX expects to provide results from the study to the FDA prior to the PDUFA action date of 8/16/09, and the Company stated that the impact of this data submission on the Agency's timing for a decision on the NDA is not yet known. NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.

 

On 7/23/09, Rigel Pharma (NASDAQ:RIGL) announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treated with R788 (fostamatinib disodium) did not report significantly higher ACR 20, ACR 50, ACR 70 and DAS28 response rates than the placebo group at three months, and therefore, the trial failed to meet its efficacy endpoints. RIGL stated that its objective with R788 in RA is to position the product after methotrexate and before biological therapies are used, and the Company believes that this patient population represents a large market opportunity for the product.

 

On 7/9/09, RIGL announced that R788 produced significant clinical improvement in rheumatoid arthritis (RA) patients in the TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA during 1H10 with a corporate partner.

 

Disclosure: No positions

 

{tiny;BIOC;3} BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the third quarter ended September 30, 2009 on Wednesday, November 4, 2009.

Management of BioClinica, Inc. will host a conference call on the same day at 11 a.m. EST. Those who wish to participate in the conference call may telephone 888-335-6674 from the U.S.; international callers may telephone 973-321-1100, approximately 15 minutes before the call. The conference ID# for both numbers is 36541392. There will be a simultaneous webcast on www.bioclinica.com. A digital replay will be available by telephone approximately two hours after the call’s completion for two weeks, and may be accessed by dialing 800-642-1687 from the U.S. or 706-645-9291 for international callers, conference ID# 36541392. The replay will also be on the website under “Investor Relations” at www.bioclinica.com for two weeks.

{tiny;MDVN;3} Medivation, Inc. (Nasdaq:MDVN) today announced that it will host a teleconference and webcast with management to discuss third quarter 2009 financial results and provide a general business update on Wednesday, November 4, 2009, at 4:30 p.m. Eastern Time. A press release for the third quarter ended September 30, 2009 will be released after markets close on November 4, 2009.

Interested parties may call 877-874-1563 from the U.S. or +1-719-325-4891 internationally. Individuals interested in listening to the live call via webcast may do so by visiting http://www.medivation.com. A replay of the webcast will be available on the Company's website for 30 days.

 

{tiny;GNVC;3} GenVec, Inc. (Nasdaq: GNVC) announced that it will release financial results for the third quarter ended September 30, 2009 on Thursday, November 5, 2009 after market close. GenVec will hold a conference call at 10:00 a.m. EST on Friday, November 6, 2009 to discuss the company's third quarter results.

To listen to the live conference call, please dial 888-679-8040 (U.S. or Canada) or 617-213-4851 (international) and use access code 35178683. Participants may pre-register for the call anytime at:

https://www.theconferencingservice.com/prereg/key.process?key=PPCBK3H6R.

Pre-registrants will be issued a PIN number to use when dialing into the live call, which will provide quick access to the conference. An audio replay of the conference call will be available starting at 1:00 p.m. on November 6, 2009 through November 12, 2009. To listen to the audio replay, dial 888-286-8010 (U.S. or Canada) or 617-801-6888 (international) and use access code 28987203.

{tiny;RIGL;3} Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that James M. Gower, chairman and chief executive officer, and Raul R. Rodriguez, executive vice president and chief operating officer of Rigel, will present at two separate investor conferences in November. Details of each conference are as follows: Oppenheimer 20th Annual Healthcare Conference Waldorf Astoria, New York City, NY November 3, 2:10 p.m. EST Speaker: Raul R. Rodriguez Credit Suisse 18th Annual Healthcare Conference Arizona Biltmore Hotel, Phoenix, AZ November 11, 2:00 p.m. MST Speaker: James M. Gower

Both presentations will be webcast. To access the live webcast or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

{tiny;HALO;3} Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced it plans to report third quarter 2009 financial results on Friday, November 6, 2009 before the open of the financial markets. The announcement will be followed by a conference call with the investment community at 8:00 a.m. PST (11:00 a.m. EST), which will be simultaneously broadcast over the Internet. Management will discuss the financial results and highlights for the third quarter 2009 and provide a product pipeline update.

To participate by telephone please dial 888-256-9044 for domestic callers or 706-643-5585 for international callers and provide the conference ID # 37881291. Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of the company’s Web site at www.halozyme.com. Shortly after the call an audio replay will be available on Halozyme’s Web site for seven days. A telephone replay will be available by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers.

Halozyme management team members will also be presenting at upcoming investor conferences.

Oppenheimer 20th Annual Healthcare Conference, November 4, 2009, 3:20 p.m. EST, New York City Lazard Capital Markets 6th Annual Healthcare Conference, November 18, 2009, 11:30 a.m. EST, New York City

To listen to the audio webcast of the presentations live or after the event, please visit the company’s Web site at www.halozyme.com. Replays will be available for 30 days after the presentations.

{tiny;ZGEN;3} ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that Stephen W. Zaruby, President of ZymoGenetics, will provide an update on company activities at the Oppenheimer 20th Annual Healthcare Conference in New York City on Wednesday, November 4, 2009 at 10:50 a.m. Eastern Time.

A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.

 

 

 

{tiny;SSRX;3} 3SBio Inc. (Nasdaq: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it will release financial results for the third quarter ended September 30, 2009 after the US market closes on Thursday, November 12, 2009.

Following the earnings announcement, 3SBio's senior management will host a conference call at 5:00 am (Pacific) / 8:00 am (Eastern) / 9:00 pm (Beijing/Hong Kong) on Friday, November 13, 2009 to discuss its 2009 third quarter financial results and recent business activity. The conference call may be accessed using the dial-in numbers below:

Conference ID: 38479039 Local dial-in: China - landline 800-819-0121 China - mobile 400-620-8038 International toll-free dial-in: Hong Kong 800930346 United Kingdom 080-8234-6646 United States 1-866-519-4004 International toll dial-in: 65-6735-7955 Replay-Conference ID: 38479039

A telephone replay will be available two hours after the call until November 20, 2009, at:

International dial-in: +61-2-8235-5000 United States dial-in: 1-866-214-5335

Webcast

A live webcast of the conference will be available on the investor relations page of 3SBio's website at http://bbs.3sbio.com/en/News/xinvestors.aspx and at http://tinyurl.com/yf93ntk . A replay of the webcast will be available within one hour after the conclusion of the call.

{tiny;OSIP;3} OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that OSI Management will present at the Oppenheimer Healthcare Conference in New York, NY on Tuesday, November 3, 2009 at 3:20pm (Eastern Time) and will provide an overview on the Company’s product portfolio and business developments.

The presentation will be webcast live and may be accessed by visiting OSI’s website at www.osip.com. A replay of the webcast will also be available on the Company’s website until November 17, 2009.

 

 

{tiny;CPIX;3} Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it will report third quarter 2009 financial results before the market opens on Tuesday, November 10, 2009.A conference call and live Internet webcast will be held on Tuesday, November 10, 2009 at 10:00 a.m. Eastern Time to discuss the results.

To participate on the call, please dial 888-417-8462 (for U.S. callers) or 719-457-2552 (for international callers).A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 888-203-1112 (for U.S. callers) or 719-457-0820 (for international callers).The passcode for the rebroadcast is 9695498.The live webcast and rebroadcast can be accessed via Cumberland Pharmaceuticals' website at http://investor.shareholder.com/cpix/events.cfm.

{tiny;INHX;3} Inhibitex, Inc. (NASDAQ: INHX) announced today that it will host a conference call on Friday, November 6, 2009 at 9:00 a.m. EDT to review the Company’s financial results for the third quarter ended September 30, 2009 and provide an update on recent corporate developments.

The Company will issue a press release regarding its financial results on the same day, prior to the conference call.

Webcast Information:  To access the conference call, please dial 877-407-8033 (domestic) or 201-689-8033 (international). A replay of the call will be available from 11:00 a.m. EDT on November 6 until December 6, 2009 at midnight. To access the replay, please dial 877-660-6853 (domestic) or 201-612-7415 (international) and reference the account # 286 and the conference id # 336098. A live audio webcast of the call and the archived webcast will be available in the News and Events section of the Inhibitex website at http://www.inhibitex.com.

Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact. Rigel Pharma (NASDAQ:RIGL): On 5/5/09, (...)[More...]