Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Affymax, Inc. (Nasdaq: AFFY), today announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced new pre-clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 - 19, 2009 in Boston, Mass.BSD Medical Corporation (NASDAQ: BSDM) (www.bsdmedical.com) today provided an update on the U.S. Food and Drug Administration’s (FDA) review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 Hyperthermia System.Clinical Data, Inc. (NASDAQ: CLDA) today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing.Delcath Systems, Inc. (Nasdaq: DCTH) announced today the closing of its public offering of 9,775,000 shares of common stock priced to the public at $3.60 per share.CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.Depomed, Inc. (NASDAQ:DEPO) announced today that William Callahan has been promoted to vice president, Operations. Mr. Callahan joined Depomed in 2002 and most recently held the position of senior director, Operations.Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors.PPD, Inc. (NASDAQ:PPDI) today announced it has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company that provides a broad range of integrated services to biopharmaceutical companies. The acquisition will expand PPD’s drug development capabilities in China.Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP), a specialty pharmaceutical company, today announced the pricing of a public offering of 5,500,000 shares of its common stock.Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported data from two nonclinical studies of voreloxin at the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference, which is being held in Boston, MA from November 15-19, 2009.Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today presented new data on the mechanism of action of elesclomol, a first-in-class oxidative stress inducer, at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass.Tongjitang Chinese Medicines Company (NYSE: TCM) (“Tongjitang” or the “Company”), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced its financial results for the quarter ended September 30, 2009 and the repurchase of ordinary shares in a private transaction.YM BioSciences Inc. (NYSE Amex: YMI; TSX: YM), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that results from a study evaluating nimotuzumab were presented today in a poster at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, Massachusetts.

 

The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma. The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions.

 

Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response was allowed at the investigator’s discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.

 

On 9/21/09, Incyte Corp. (NASDAQ: INCY) ($7.97, +9%, above-average volume on 21-Sep) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial.

 

Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters. Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.

 

On 9/21/09, results were presented in Europe by OncoMethylome Sciences (EBR: ONCOB.BR) ($6.60, +10%, above-average volume on 21-Sep) for a blood-based diagnostic test for colorectal cancer (CRC). The researchers collected blood before surgery from 193 patients known to have CRC, as well as from 688 controls undergoing colonoscopy for cancer screening. DNA was extracted from the blood plasma and tested for the presence of DNA methylation of specific genes. Based on studies conducted in colorectal tissues, methylated genes that were capable of discriminating accurately between cancerous and normal tissues were chosen, including two newly reported methylation genes, SYNE1 and FOXE1, in patients with CRC that occur infrequently in individuals who do not have the disease.

 

When testing a first set of 444 controls and 124 colorectal cancer patients, with plasma volumes ranging between 0.8—4.3 mL (as a reference point, 1 teaspoon = 5 mL), the sensitivity and specificity for the combination of SYNE1 and FOXE1 was 58% and 90% respectively. Testing this marker combination in a second, independent group of 242 controls and 69 cases, the sensitivity (proportion of positives correctly identified) and specificity (proportion of negatives correctly identified) were 56% and 91% respectively (77% and 91% in the samples with at least 3.3 ml of plasma).

 

The sensitivity for stage I and II CRC was 41% and 80%, respectively. The scientists are currently enrolling people into a prospective colorectal screening study in several German colonoscopy facilities and expect to complete enrollment of 7,000 people by the end of 2009 in conjunction with discussions to several partners about distribution rights.

 

The V3 stool DNA screening technology being developed by EXACT Sciences (NASDAQ:EXAS) outperforms blood-based tests, especially for earlier stage disease / pre-cancer detection, which is critical for improved treatment and survival outcomes. In August 2008, research was published in which a total of 25 sDNA samples from CRC patients were analyzed and a next generation stool DNA technology (V3) correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA.

 

In addition, improvements to stool DNA screening technology to-date include ability to detect over 85% of CRCs and 50% of pre-cancers (higher than the 41% sensitivity for Phase I CRC reported yesterday by OncoMethylome) versus rates of about 50% and 20%, respectively, with potential to expand sDNA screening technology for other GI-related cancers such as gastric, pancreatic, etc. after commercializing the V3 test for CRC.

 

Another key development for EXAS discussed at the Rodman Healthcare conference is the replacement of a large collection bucket associated with the Company’s stool DNA screening test for CRC with a much smaller (less than two ounces) system that will greatly enhance the commercial prospects and logistics associated with the development of the next-generation V3 test. The much smaller size of the collection system for the V3 test will make it much easier for doctors to store in their offices and simplify the shipping process for lab processing.

 

This adds to positive news announced during the 2Q09 conference that the Company’s pending Phase 3 FDA study is likely to be much smaller in scale (e.g. 3,000 subjects) and less costly versus the previous guidance of 8,000-10,000 subjects enrolled at 30-40 clinical sites that would have taken 12-18 months to complete. The objective of this study is to obtain broad claims and FDA marketing clearance for a non-invasive stool DNA based CRC screening test, including the detection of pre-cancers. The stock research section of BioMedReports.com includes my 2Q09 update report for EXAS, including an earnings model in the U.S. market, targeting a major unmet medical need for an estimated 90 million people over the age of 50.

 

On 9/22/09, BSD Medical (NASDAQ: BSDM) ($3.85, +105%, above-average volume on 22-Sep) announced that clinical trial results were the subject of a news briefing at Europe’s largest cancer congress (ECCO15 – ESMO34) which utilized the BSD-2000 Hyperthermia System, demonstrating that patients with high risk soft-tissue sarcomas were 30% more likely to be alive and cancer free almost three years after starting treatment if targeted heat therapy (hyperthermia) was added to their chemotherapy treatment.

 

The Phase 3 study involved 341 patients who were treated at medical centers in Europe and in the U.S. All patients had locally advanced soft tissue sarcomas and were at high risk of recurrence and spread. All patients were given chemotherapy before and after surgery and radiotherapy. Half of the patients were randomly given hyperthermia along with chemotherapy.

 

“The patients receiving the targeted heat therapy fared better on all outcome measurements,” Prof. Issels said. “Almost three years after starting treatment, they were 42% less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone, surviving an estimated 120 months before local progression of their disease, compared with an estimated 75 months. Similarly, the average length of time that patients remained disease free was 32 months in the group that got both treatments, compared with 18 months in the group that got chemotherapy alone – an improvement of 30%.”

 

On 5/18/09, BSDM announced that the FDA has granted Humanitarian Use Device (HUD) designation for the company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device’s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the U.S. per year.

 

Now that FDA has granted the HUD for the BSD-2000, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. BSDM believes that data previously submitted to FDA and reviewed by the Agency as part of the Company’s pending medical device Pre-market Approval (PMA) submission can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.

 

Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the Company’s strong desire to bring the BSD-2000 to market as quickly as possible, the FDA recommended that BSDM pursue a HDE marketing approval to authorize the commercial sale of the BSD-2000 in the U.S. On 1/7/08, BSDM received a letter from the FDA providing guidance as to amendments needed to make the PMA approvable and the Company responded to this letter on 7/17/08.

 

In a letter to shareholders on 7/29/09, BSDM stated that, “We expect to hear from the FDA very soon regarding our HDE application.”

 

Disclosure: Long EXAS.

 

See my full disclaimer at MikeHavRx.com (bottom of any page).

 

Below is a list of the companies that made news in the healthcare sector on Friday, October 30, 2009. Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Biodel Inc. (Nasdaq:BIOD) announced Dr. Solomon Steiner, Chairman and CEO of Biodel, will present a corporate update at the Oppenheimer 20th Annual Healthcare Conference on November 3rd, 2009 at 9:40 am Atlantic Time.

AMRI (NASDAQ:AMRI) announced AMRI Director of Investor Relations Peter Jerome will present at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009 at 3:20 p.m. EST.

BioScrip, Inc. (Nasdaq:BIOS) announced third quarter net income of $5.7 million, or $0.14 per diluted share, on revenues of $333.5 million. These results compare to net income of $1.4 million, or $0.04 per share, on revenues of $359.4 million for the third quarter of 2008.

Celgene Corporation (NASDAQ:CELG) announced its presentation at the Oppenheimer & Co. Inc. 20th Annual Healthcare Conference on Wednesday, November 4, 2009 at 10:15 a.m. ET will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com. Celgene management will provide an overview of the company.

ARYx Therapeutics, Inc. (NASDAQ:ARYX) announced it will present at the Oppenheimer 20th Annual Healthcare Conference in New York on November 4, 2009 at 10:15 am Eastern.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

China-Biotics, Inc. (Nasdaq:CHBT), a leading Chinese firm specializing in the manufacture, research, development, marketing and distribution of probiotics products, announced the appointment of Dr. Tom Gu as Vice President, effective November 2.

BMP Sunstone Corporation (Nasdaq:BJGP), announced it will participate in the following conferences: -- Oppenheimer 20th Annual Healthcare Conference, to be held November 3-4, 2009 at the Waldorf=Astoria hotel in New York.

Warner Chilcott plc (Nasdaq:WCRX) announced it has completed the acquisition of The Procter & Gamble Company's global branded prescription pharmaceutical business.

NeoStem, Inc. (NYSE:NBS), announced the Company has completed theacquisition of China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

BSD Medical Corporation (NASDAQ:BSDM) announced published study results demonstrated improvement in overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy, delivered using the BSD-2000 Hyperthermia System, to the standard treatment regimen for 45 patients with high-risk bladder cancer.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it will release its financial results for the third quarter ended September 30, 2009 prior to market open on Wednesday, November 4, 2009.

Emergent Health Corp. (OTC:EMGE) Emergent (the “Company”) is pleased to announce a forward stock split of 11 shares for each 10 shares owned.

NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced it will hold a conference call on Friday, November 6, 2009 at 9:00 a.m. ET (6:00 a.m. PT) to report results for its third quarter 2009.

Rosetta Genomics (NASDAQ:ROSG) announced Ayelet Chajut, its Executive Vice President, R&D, Head of Molecular Biology will speak at the 6th International Conference on Circulating Nucleic Acids in Plasma and Serum (CNAPS-VI).

Shire plc (NASDAQ:SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

Valeant Pharmaceuticals International (NYSE:VRX) announced it has agreed to acquire the rights to several prescription and cosmetic dermatology products from a privately-held, Polish specialty pharmaceutical company.

Impax Laboratories, Inc. (NASDAQ:IPXL) confirms it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICO® (fenofibrate) tablets, 48 mg and 145 mg.

PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced Michael J. Culota, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009, at 10:50 a.m. Eastern Time.

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) announced it is scheduled to make an investor presentation at the 20th Annual Oppenheimer Healthcare Conference. David Seltzer, President and Chief Executive Officer, will deliver the Company's presentation on Tuesday, November 3, 2009, at 3:55 p.m. Eastern Time.

GTx, Inc. (NASDAQ:GTXI) announced it will host a conference call and webcast on Monday, November 2, 2009 to provide an update regarding the New Drug Application for toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy.

Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) will release its third quarter 2009 financial results on November 9, 2009, after the stock market closes, and will host a conference call at 8:30 AM Eastern Time on November 10, 2009.

Covidien (NYSE:COV), a leading global provider of healthcare products, announced its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Novavax, Inc. (Nasdaq:NVAX) announced it will report its 2009 third quarter financial results in a press release to be issued after 8:00 am local time on Friday, November 6, 2009.

Geron Corporation (Nasdaq:GERN) announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based produc , GRNOPC1, for the treatment of spinal cord injury.

BSD Medical Corporation (NASDAQ:BSDM) today announced that their published study results demonstrated improvement in the overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy delivered through BSD-2000 Hyperthermia System. ...

Below are FDA extreme trades among 16 companies with stock prices under $5 from the BioMedReports.com FDA Calendar (database includes 225 entries as of 6/27/09) which have pending FDA decisions for either new drug products, biological agents, medical devices, or diagnostic tests that may have a major impact on each of the underlying stock prices. 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 (...)[More...]