Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 273 entries as of 7/22/09. 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 7/22/09, Schering-Plough (NYSE:SGP) announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate was filed and accepted for review by the FDA. The NDA is seeking marketing approval from the FDA for the maintenance treatment of asthma in patients 12 years of age and older. This new product combines the active ingredients of already-approved and marketed single-agent products which include an inhaled corticosteroid (Asmanex -mometasone furoate inhalation powder) and a long-acting beta2-agonist (Foradil - formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. SGP has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination and is in the process of being acquired by Merck (NYSE:MRK).
On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.
On 7/22/09, Human Genome Sciences (NASDAQ:HGSI) reported its quarterly results and stated that the Company and Novartis (NYSE:NVS) have completed pre-submission meetings with the FDA and EMEA regarding Zalbin (albinterferon-alfa 2b, formerly Albuferon) with planned submissions for global regulatory marketing approvals on track for fall 2009 seeking treatment of hepatitis C (HCV) types 2 or 3 viral infection. In April 2009, positive Phase 3 results for Zalbin in patients with chronic hepatitis C were presented at a medical conference and data from two pivotal Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, showed that Zalbin met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a). With half the injections, Zalbin achieved a rate of sustained virologic response comparable to Pegasys in these studies and comparable safety results.
On 7/22/09, Bovie Medical (AMEX:BVX) announced a 510(k) submission to the FDA seeking pre-market clearance for the Company's Polarian Seal-N-Cut vessel sealing line of hybrid monopolar and bipolar forceps. The new Seal-N-Cut line of instruments provides for monopolar and bipolar energy combined with intelligent feedback from Bovie’s Hybrid VS electrosurgical generator. The Seal-N-Cut devices also accommodate a wide array of possible applications in either monopolar or bipolar surgeries thereby serving endoscopic needs in multiple endoscopic fields including Endo GYN, General Surgery, Pediatric surgery, Thoracic Endoscopy and Urology. Bipolar vessel sealing and coagulation is one of the fastest growing markets in Endoscopy, estimated to exceed $1 billion in revenues worldwide.
On 7/22/09, Bayer (OTCPK:BAYRY) and Onyx Pharma (NASDAQ:ONXX) announced that their first cooperative group-sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p = .0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Onyx and Bayer are currently evaluating various strategies for Nexavar in breast cancer.
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