Genzyme Corporation has announced that they have received a complete response letter from the Food and Drug Administration about the company’s supplemental New Drug Application for Clolar in patients suffering from acute myeloid leukemia or untreated older patients with AML. In the response letter to Genzyme Corporation, FDA has clearly mentioned that they need to have a randomized and controlled clinical trial be conducted for label expansion of Clolar. Genzyme’s Clolar drug is currently approved for pediatric ALL patients who have relapsed or have refractory diseases. FDA has also granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.

In September, FDA Oncologic Drugs Advisory Committee voted for Clolar and had emphasized that it was necessary to establish the efficacy and safety of Clolar for

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Genzyme Corp.’s (GENZ) Clolar could face a delay in receiving approval for an expanded indication. The drug will be coming up for review before the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on Sept 1 and questions have been raised regarding the lack of a randomized study supporting the application.

The company is seeking to get Clolar approved for the treatment of previously untreated adults aged 60 or older with acute myeloid leukemia (AML) who have at least one unfavorable prognostic risk factor. The company is seeking approval on the basis of a phase II study in which Clolar was evaluated in elderly patients with previously untreated AML and at least one other factor that gave them a poor prognosis. The study did not include any comparison with a placebo.

Clolar is currently approved for pediatric acute lymphoblastic leukemia (ALL) patients who have relapsed or refractory

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Logitech (SIX:LOGN) (NASDAQ:LOGI) introduced two options to help you make a big impact during your next presentation - the Logitech® Professional Presenter R800 and the Logitech® Wireless Presenter R400. With laser pointing, wireless convenience and intuitive slideshow controls that can be found by touch, Logitech’s new presenters give you the confidence to move freely around the room, so that you can focus on delivering a more effective and powerful presentation.

About Logitech Logitech is a world leader in personal peripherals, driving innovation in PC navigation, Internet communications, digital music, home-entertainment control, gaming and wireless devices. Founded in 1981, Logitech International is a Swiss public company listed on the SIX Swiss Exchange (LOGN) and on the Nasdaq Global Select Market (LOGI).

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid

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On July 7, 2009, Celgene International Sàrl, the Swiss unit of biopharmaceutical company Celgene Corp. (CELG) filed  a New Drug Application (NDA) with the Japanese Ministry of Health, Labor and Welfare (MHLW) for Revlimid in combination with dexamethasone for the treatment of multiple myeloma (MM) patients with at least one prior therapy. The filing was based on the safety and efficacy results of two late-stage trials – the North American trial MM-009 and the International trial MM-010 which evaluated Revlimid plus dexamethasone in MM patients with at least one prior therapy. The studies were published in the New England Journal of Medicine in November 2007. The Revlimid–dexamethasone combination for the treatment of MM patients with at least one prior therapy is already approved in nearly 50 countries worldwide. Revlimid was granted orphan drug status in Japan in February 2008 for deletion 5q myelodysplastic syndromes (MDS) as ...

Access Pharmaceuticals, Inc. announced earlier this morning new preclinical data demonstrating that thiarabine, one of the company’s advanced drug delivery technologies, shows extraordinary efficacy in preventing and treating rheumatoid arthritis (RA). In a well-established animal model for RA, a remarkable restoration of joint structure was observed. The studies were conducted at Wayne State University School of Medicine and at Southern Research Institute.

According to the press release, thiarabine treatment resulted in a broad inhibition of disease pathology, with reduction of both inflammatory and erosive disease parameters, as well as protection from loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a considerable reduction in disease incidence and severity at 20 mg/kg/day.

Perhaps even more exciting, in a therapeutic study comparing thiarabine to methotrexate, a commonly used clinical drug for RA treatment, high resolution

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Since I last wrote about Access Pharma [ACCP: 0.00, N/A (N/A)] two weeks ago as a cancer biotech call option trade, the Company has issued two updates on its clinical development pipeline and two updates for MuGard – which is an oral rinse product for the management of a common side effect of many cancer therapies, mucositis. In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece, and the Nordic countries by its European commercial partner, SpePharm, with expected launches in North America, Asia, and other regions slated for later this year. On 6/10/09, ACCP.OB also announced that the Company received issue notifications from the United States Patent and Trademark Office for two US patents (numbers 7,544,348 and 7,547,433).

A video presentation is available at ProActiveNewsRoom.com for MuGard, in addition to more information and links at the landing page

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Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with 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. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in extreme FDA and Clinical Trial Calendar trades, which are highlighted in periodic articles at BioMedReports.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no

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Shares of Vanda Pharma [VNDA: 7.87, +6.79 (+628.70%)] 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.

1.) Vion Pharma [VION: 0.00, N/A (N/A)]: Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as

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Below are 12 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.

BioMedReports.com FDA Calendar

1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). 4/17/09 is date for FDA to accept the filing and rule on priority review request - if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.

2.) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last

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On Apr 1, 2009, Sunesis Pharmaceuticals (SNSS) reported fourth-quarter 2008 results.

No material revenue was recorded in the fourth quarter of 2008, compared to $1.8 million in the fourth quarter of the prior year. Revenue totaled $5.4 million for the year ended Dec 31, 2008, compared to $9.7 million for the year ended Dec 31, 2007.

The decrease in revenue year-over-year was primarily due to the conclusion of the research phase of the kinase inhibitor collaboration with Biogen Idec in Jun 2008 and lower amortization of license fees and milestone payments from the collaboration with Merck & Co., Inc.

Sunesis reported a net loss of $6.9 million ($0.20 per share) for the quarter and $37.2 million ($0.93 per share) for the 12-month period ended Dec 31, 2008, compared to a reported net loss of $8.4 million ($0.25 per share) and $37.2 million ($1.15 per share), respectively, for the

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