On 8/4/09, U.S. advisers backed FDA guidelines for testing less costly generic versions of the antibiotic Vancocin (vancomycin) despite objections by the brand product manufacturer ViroPharma (NASDAQ:VPHM). VPHM argued that the Agency's proposed criteria for generic rivals were not rigorous enough to prove the copies would work as well as the brand-name product. But panel members said they felt confident in the FDA's suggested test methods for generics, and the committee voted 16-0 to back the FDA plan for generic versions of Vancocin.
The Advisory Committee was asked if the proposed FDA Office of Generic Drugs (OGD) guidelines and the use of in vitro (outside of the human body - i.e. requiring no clinical trials to prove) dissolution methods are sufficient for establishing bioequivalence for generic vancomycin oral capsules. The Advisory Committee voted unanimously in favor of the proposed OGD recommendation to demonstrate bioequivalence through equivalent dissolution in media of pH 1.2, 4.5 and 6.8 for potential vancomycin HCl capsule generic products that: (1) contain the same active and inactive ingredients in the same amounts as Vancocin capsules; (2) meet currently accepted standards for assay, potency, purity, and stability; and (3) are manufactured according to cGMP.
On 8/4/09, Electro-Optical Sciences (NASDAQ:MELA) announced that the FDA formally accepted for filing the company's Pre-Market Approval (PMA) submission seeking marketing clearance for MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The filing date for regulatory purposes is 6/9/09, which is the date the FDA received the Company's submission. The FDA also confirmed that the PMA application will receive expedited review and processing with an expected review period of six months.
Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May. The Company's final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians.
On 8/4/09, Wyeth (NYSE:WYE) and Progenics Pharma (NASDAQ:PGNX) announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010.
On 10/14/09, Progenics Pharma (NASDAQ: PGNX) announced a deal with Wyeth to re-acqurie all of the worldwide rights to the RELISTOR franchise after a one-year transition period.
RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. PGNX will aggressively continue development to expand the utility of both subcutaneous and oral RELISTOR into a new population for patients with chronic pain who experience OIC.
On 8/4/09, Wyeth and PGNX announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010. Single-use vials of RELISTOR will continue to be available. The estimated PDUFA action date is 6/4/10 for a standard, 10-month review and possible FDA decision on this sNDA.
On 10/14/09, Somanetics (NASDAQ: SMTS) announced that it has signed an Exclusive Sublicense Agreement with Raba Equity Partners II and obtained exclusive rights to new cerebral auto-regulation technology developed at The Johns Hopkins University. Integration of this technology into Somanetics' INVOS Cerebral / Somatic Oximeter would yield the first noninvasive monitor providing cerebral auto-regulation data for routine clinical use. SMTS plans to utilize this patent-pending method of combining blood pressure measurements and signals from the INVOS System to continuously monitor and display cerebral auto-regulatory function information.
SMTS plans to file a new 510(k) pre-market notification with the FDA to support marketing the new module in the U.S. by late 2010 and initiate product shipments for sale early in 2011. Cerebral auto-regulation refers to the body's ability to maintain constant blood flow to the brain despite changes in blood pressure. In many critical care situations, the brain's auto-regulation can become impaired, making it vulnerable to changes in blood pressure and to potential brain injury due to loss of this critical protective mechanism.
On 10/14/09, Ziopharm Oncology (NASDAQ: ZIOP) reported positive top-line interim data from the multicenter randomized Phase 2 trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed. As a result of reaching a key efficacy milestone and following safety and efficacy data review by the Data Committee, sarcoma experts, and the Company's Medical Advisory Board, the decision was reached formally to stop enrollment yesterday in the trial. The Company will report the interim data in full at the upcoming Connective Tissue Oncology Society Annual Meeting on November 5th and plans to initiate a registration / pivotal Phase 3 study following regulatory review of the palifosfamide program to date.
The Randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. A total of 58 patients have been evaluated for PFS (progression-free survival) with 19 documented PFS events (doxorubicin alone = 13 events; palifosfamide + doxorubicin = 6 events) based on a three month median follow-up time. With this analysis based on all randomized and eligible patients, the hazard ratio is 0.67 favoring palifosfamide + doxorubicin, which is the pre-defined milestone was to reach one-sided p=0.1. The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin.
On 10/14/09, Cardium Therapeutics (AMEX: CXM) reported Phase 2b results for the Excellarate product candidate and its components, demonstrating that Ad5PDGF-B and collagen matrix appear to be both safe and well tolerated by patients. The Phase 2b Matrix clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate - but both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care, which is the FDA-accepted control considered appropriate for product registration studies. Approximately 45% of patients receiving the collagen matrix in the Phase 2b study had complete wound closure by 12 weeks, compared to a 31% wound closure rate for the standard of care group.
Based on the Company's clinical studies to date, Cardium will consider submitting an application for FDA 510(k) clearance of Excellagen for use in wound healing applications since collagen is cleared for marketing as a medical device already. (1) Excellagen (a collagen-based topical gel for use by physicians in conjunction with surgical debridement of wounds in patients with chronic or non-chronic diabetic foot ulcers) is expected to be advanced via the FDA 510(k) medical device route while (2) Excellarate (includes both the collagen matrix and the PDGF-B protein to promote wound healing) (Regranex also contains this protein) is expected to proceed to a Phase 3 clinical study for non-healing diabetic foot ulcers.
On 10/14/09, pSivida Corp. (NASDAQ: PSDV) announced that the last patient in the Phase 3 study being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit. The Phase 3 studies compare two doses of Iluvien with placebo. PSDV expects to report top-line 24-month data from the trial in mid-December and if the data are positive expects to file a NDA with the FDA during 2Q10.
On 6/15/09, PSDV announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.
On 6/17/09, BioMimetic Therapeutics (NASDAQ: BMTI) announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. On 10/13/09, BMTI announced positive top-line results from its pivotal (Phase3) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft ("Augment"), to autograft for use in hindfoot and ankle fusion surgery.
The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient's body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation. All p values reported in this release are derived from non-inferiority analyses. Analysis of the complete data set will continue for some time. A substantial amount of data in addition to the top-line data announced today will be included in the Company's PMA submission, which is expected to be filed with the FDA within the next three months.
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On 10/14/09, Progenics Pharma (NASDAQ: PGNX) announced a deal with Wyeth to re-acquire all of the worldwide rights to the RELISTOR franchise after a one-year transition period. RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care.[More...]
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 288 entries as of 8/5/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete (...)[More...]
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 200 entries. 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 lett (...)[More...]
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