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 additional 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/4/09, Abbott Labs [ABT: 45.42, +0.86 (+1.93%)] and AstraZeneca [AZN: 43.34, +1.70 (+4.08%)] announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two

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FDA Issues Complete Response Letter for Cinryze in Acute HAEOn June 3, 2009, the U.S. FDA issued a complete response letter (CRL) relating to ViroPharma's (VPHM) supplemental biologic license application (sBLA) on Cinryze for the treatment of acute attacks of hereditary angioedema (HAE). The CRL requests an additional clinical study, due to the FDA's opinion that the placebo controlled study submitted in support of the sBLA lacked robustness.We note that the phase III data submitted with the sBLA contained data from a 71-patient trial. ViroPharma also submitted data from an 82-patient open-label program along with the phase III trial.At this point it is difficult to assess just how much more data the FDA would like to see. We note that the phase III program for DX-88 (ecallantide) submitted by Dyax Corp. contained data from 143 unique patients before the open-label program. This ...

ViroPharma: One-Trick Pony or Thoroughbred?We have been long-time bulls on ViroPharma, Inc. (VPHM), but the loss of maribavir hurts. The economic value of Vancocin is rapidly approaching an end. At this point, it is not a question of "if" generics will arrive; it is a question of "when" they will arrive. Obviously the later the better, but with maribavir now gone, one thing is certain -- ViroPharma's future is now tied solely to Cinryze.It is our belief that ViroPharma will become a one-trick pony, Cinryze, by the start of 2010. That's not necessarily a bad thing if that pony turns out to be a thoroughbred. Some of the things that could make Cinryze a thoroughbred include rapid uptake by the 200+ clinical trial patients and women and children actively seeking treatment options. Plus, Cinryze is the only viable treatment option for patients seeking prophylactic ...

ViroPharma (VPHM) Soon to Be a One-Trick PonyIn the past two years, we have seen both HCV-796 (for HCV) and maribavir (for CMV) fail clinical programs. These were two products that we previously believed would be on the market and contributing to ViroPharma’s (VPHM) top-line by 2011. Paramount to our investment these for ViroPharma was that all the cash being spun-off by Vancocin, an asset with a definite and rapidly approaching terminal economic life, would allow management to develop and commercialize the next wave of growth starting in 2010. With both HCV-796 and maribavir gone, ViroPharma will become a one-trick pony quickly after the arrival of generic oral vancomycin.Despite our belief that Cinryze is an excellent product and was a fine acquisition by ViroPharma management, it has very different profitability characteristics than Vancocin. Yes, both products have peak sales at $250 million, but …

Emerging Biotech & Pharma Index: 36 More Cos. The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff. However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news. Late last week, Ligand Pharma (LGND) received approval along with its collaboration partner Glaxo (GSK) for Promacta while Theravance (THRX) received a positive panel review for its antibiotic telavancin. Previously, ...

Dyax Corp. (Nasdaq: DYAX) focuses on the advancement of novel biotherapeutics, such as those for the treatment of hereditary angiodema (HAE), a rare and potentially life-threatening condition that occurs in about one in every 10,000 to 50,000 people. The condition is associated with swelling in various parts of the body (including hands, feet, face and airway), abdominal pain, and nausea and vomiting.

Dyax today announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax’s flagship product, DX-88 (ecallantide), for the treatment of HAE.

“The submission of the DX-88 BLA is a major milestone for Dyax,” Henry E. Blair, chairman, president and CEO of Dyax stated in the press release. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working

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Dyax Corp. (Nasdaq: DYAX) is a clinical-stage drug company focused on the discovery, development and commercialization of biotherapeutics for oncology and inflammatory conditions. The company today announced positive topline results from its second phase-3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE), or the rapid swelling of the skin.

The trial utilized the participation of 96 patients and was conducted at 42 sites in the United States and Canada. The company’s anticipated goal was to determine the efficacy and safety of a fixed 30 mg. subcutaneous dose of DX-88 in the treatment of moderate to severe acute HAE attacks.

The EDEMA4 trial was conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) and marked significant improvements in the intent-to-treat population in primary and secondary endpoints. The trial was consistent with outcomes of the first phase 3 placebo-controlled trial (EDEMA3) for

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