As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA
could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo
for use as-needed for the treatment of insomnia when a middle of the night awakening is
followed by difficulty returning to sleep.
The FDA indicated that the intended use of Intermezzo in the middle of the night represents
a unique insomnia indication and dosing strategy for which safety has not been previously
established and the Agency requested additional data demonstrating that Intermezzo,
when taken as directed in the middle of the night, would not present an unacceptable
risk of residual effects, with particular reference to next day driving ability. The FDA also
expressed two concerns regarding the possibility of patient dosing errors in the middle
of the night that could lead to next day residual effects.
Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an
update on its discussions with the FDA and the status of the anticipated Intermezzo NDA
resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive
deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue
will pay TSPT near-term milestones that include an upfront cash payment of $25 million
and an additional payment of up to $30 million.
On 11/23/09, ProUroCare (OTC: PUMD.OB) announced that a 510(k) submission for U.S
. market clearance of a prostate mechanical imaging system has been filed with the FDA,
seeking a labeling claim for the device as an aid to visualize and document abnormalities
of the prostate detected and/or monitored by digital rectal examination (DRE). The system
incorporates the company's unique and patented tactile elasticity imaging technology that
creates a "map" of the prostate and an electronic record that can be stored for future analysis.
On 10/8/09, announced the completion of a National Institute of Health and National Cancer
Institute-supported clinical study. The study's purpose was to evaluate the ability of the
company's ProUroScan imaging system to visualize and document abnormalities in the
prostate detected or monitored by the DRE. The ProUroScan imaging system is designed
to complement the DRE, and to provide patients with potential prostate abnormalities the ability
to have their prostates imaged in real time with records electronically stored for later comparison.
On 11/23/09, SciClone Pharma (NASDAQ: SCLN) announced that patient enrollment is
complete ahead of schedule for its Phase 2 trial of SCV-07, which is a small molecule
synthetic peptide with immune-modulating properties, for the treatment of severe oral
mucositis (OM) in patients with head and neck cancer. Top-line results of the oral
mucositis trial are expected to be announced during 1H10.
The multi-center, randomized, double-blind, placebo-controlled, dose ranging study is designed
to assess the safety and efficacy of SCV-07 for the delay to onset and severity of OM in
patients receiving standard chemo-radiation therapy for treatment of cancers of the head
and neck. SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates
the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells.
On 11/23/09, ARCA biopharma (NASDAQ: ABIO) announced that the FDA has
designated as a Fast Track development program the investigation of Gencaro,
the Company's experimental, pharmacologically unique beta-blocker and mild vasodilator
, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in
a genotype-defined heart failure population. Last week, ABIO stated that it intends
to submit a study protocol during 4Q09 for review under the FDA's Special Protocol
Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy
of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype
that appears to respond most favorably to Gencaro.
ARCA anticipates that the proposed trial protocol will be a superiority comparison
to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other
indications. Subject to the timing and outcome of the Agency's review of the SPA
submission, and subject to the Company's ability to obtain sufficient funding, the
Company currently expects it could begin the proposed trial in late 2010 or 1H11. On 6/1/09,
ABIO announced that it received a CRL from the FDA for the Gencaro NDA for the treatment
of patients with chronic heart failure.
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The BioMedReports.com FDA Calendar service includes a database with over 400 entries
of (1) pending new drug, biological agent, or medical device new product decisions at the
FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions t
o the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA;
and (4) pending clinical trial results.
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