FDA Calendar Updates: Royal Returns for King Pharma Print E-mail
Monday, 11 May 2009 09:44
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. Shares of King Pharma (NYSE:KG) have gained about 35% since I wrote about the Company in late March as a value play on pending new drug approvals. Below are updates on three new pain drug candidates from King's quarterly results and business update today.  
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Could newly approved brain cancer drug help Sen. Edward Kennedy? Print E-mail
By Jude Santos   
Monday, 11 May 2009 03:00
While it had been more than 10 years since a new treatment for the same type of tumor Sen. Edward M. Kennedy, D-Mass., has been fighting (glioblastoma) was approved, the U.S. Food and Drug Administration has just granted accelerated approval for Switzerland-based Roche's (VTX:ROG) Avastin (bevacizumab) for use against the aggressive brain cancer tumors.
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NeurogesX Awaits Dual Regulatory Decisions Print E-mail
Sunday, 10 May 2009 03:00
NeurogesX (NASDAQ:NGSX) represents a two-in-one extreme trade on pending FDA and EMEA regulatory decisions to market its nerve pain patch in both the E.U. and U.S. markets. NGSX was not included in my previous article of nine remaining extreme trades on pending FDA decisions since the Company provided a business update along with its quarterly results after the market close on Thursday. Click here for a link to the BioMedReports FDA and Clinical Trial Calendars page. On 3/19/09, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. The CHMP's recommendation for the MAA, filed under the centralized procedure, is subject to a final decision by the European Commission, usually rendered approximately 60 to 90 days after the CHMP's recommendation.
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FDA, Clinical Trial Calendars: Nine Cash Plus Catalyst Trades Print E-mail
Sunday, 10 May 2009 03:00
Below are nine 'Cash Plus Catalyst' trades which include companies that are currently trading for around 2X net cash/equivalents or less (the ratio of market cap to cash/equivalents less debt) with pending FDA decisions, clinical trial results, or pending FDA submissions. Click here for a link to the BioMedReports FDA and Clinical Trial Calendars page. 1.) BioForm Medical (NASDAQ:BFRM): Market Cap = $59.8M, Net Cash = $41.4M. In March 2009, BioForm Medical announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE dermal filler, which demonstrated an approximate 60% reduction of pain when RADIESSE dermal filler was mixed with lidocaine, and comparable safety and effectiveness of mixed and non-mixed RADIESSE dermal filler. The results were submitted to the FDA under a PMA supplement with an estimated decision during 4Q09 since the FDA does not issue decision date deadlines for medical device filings.
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Cell Therapeutics: Turnaround Remains On Track Print E-mail
Thursday, 07 May 2009 17:56
The dramatic turnaround from lows of a nickel per share ealier this year at cancer biotech Cell Therapeutics (NASDAQ:CTIC) remains on track as the Company announced its 1Q09 results today, which included a 76% reduction of net loss and expected completion of the pixantrone NDA filing this June. Earlier this week, CTIC announced that pixantrone was made available through a compassionate use program in Europe on a named-patient basis for use in the treatment of aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed or is refractory to standard treatment options. CTIC achieved its objective thus far during 1H09, including the initiation of the rolling NDA submission for pixantrone, reducing net loss through cost cutting initiatives, raising gross proceeds of $44.3M, and cleaning up the Company's capital structure through the elimination of all previously issued preferred stock. CTIC is on target to complete the pixantrone NDA filing by June and if the FDA grants a priority revew, the Company could receive an approval decision before year-end in December.
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FDA, Clinical Trial Calendar Updates: WYE, SVNT, AMRN, ISIS, SLXP, SOMX Print E-mail
Thursday, 07 May 2009 17:04
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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An Extreme FDA Trade that Paid: Vanda Pharma (NASDAQ:VNDA) Print E-mail
Wednesday, 06 May 2009 18:55
Shares of Vanda Pharma (NASDAQ:VNDA) soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the FDA for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.Below are the nine remaining companies from my article last month on a dozen extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.
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First ever drug from a genetically modified animal goes to market Print E-mail
By M.E.Garza   
Wednesday, 06 May 2009 16:17
Drug from goatsOn May 6th Lundbeck Inc. launched ATryn® (Antithrombin [Recombinant]), the first transgenically produced drug available in the U.S. Antithrombin is a naturally occurring protein that helps regulate the blood clotting mechanism in the body. The drug is the first ever biological product produced by a genetically engineered animal - a goat. ATryn is an anticoagulant, used for the prevention of blood clots. It is for patients who have a rare disease known as AT (hereditary antithrombin) deficiency. Patients are at high risk of blood clots when they undergo medical intervention such as surgery, and during/before and after childbirth.
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FDA Calendar Updates: Acorda, Roche Print E-mail
Wednesday, 06 May 2009 09:50
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. 1.) Acorda Therapeutics (NASDAQ:ACOR): On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct formatting issues with the application and requested additional supporting information before the NDA could be accepted for review. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS. 2.) Roche (VTX:ROG) (OTC:RHHBY): Following the recommendation of an advisory panel, the FDA approved Avastin for use against an aggressive and deadly form of brain cancer known as glioblastoma based on encouraging early clinical trial data on an accelerated approval basis since there have been no new treatments for this condition in the past decade.                                      Disclosure: No positions.
 
FDA Calendar Updates: CTIC, ALKS, AMLN, LLY Print E-mail
Tuesday, 05 May 2009 14:36
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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