Progenics Submits sNDA To FDA. Sinovac Commences Phase II Clinical Trial for EV71 Vaccine Print E-mail
By Staff and Wire Reports   
Tuesday, 28 June 2011 20:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 28, 2011.

Progenics Pharmaceuticals, Inc., (NASDAQ:PGNX), has submitted RELISTOR, to the FDA for New Drug Application (sNDA) approval to the U.S. Food and Drug Administration (FDA) requesting approval for the use of RELISTOR (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC.

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Sinovac Biotech Ltd. (NASDAQ:SVA), announced the commencement of the Phase II clinical trial for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).  The safety observation results from the EV71 vaccine Phase I trial completed in May 2011 showing good safety and tolerance profiles for all three age groups (adult, children and infant groups) and the preliminary immunogenicity study results showed the vaccine can induce good immune responses.

The purpose of the Phase II clinical trial is to determine the dosage level through evaluating the immunogenicity and safety with different level of dosages of Sinovac's EV71 vaccine candidate, and to provide the reference data for Phase III clinical trial. The phase II clinical trial is designed as a single center, randomization, double blinded, and placebo controlled study. In phase II, there will be 540 healthy volunteers from 3 to 35 months old, separated in three age groups. Dosing with the first shot was started on schedule. It is anticipated to take 6 months to complete the phase II clinical trial.


Also Tuesday:


CardioVascular BioTherapeutics, Inc. (PINK:CVBT) today announced it has engaged the Certified Public Accounting Firm, Malone Bailey LLP , to audit the years ending December 31, 2008, 2009 and 2010 and to review the quarterly filings for 2009, 2010, and 2011.

Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that it has been added to the Russell 3000®, Russell 2000® and Russell Global Indexes posted by Russell Investments on June 27, 2011 at www.russell.com.

Today at the BIO International Convention, Eli Lilly and Company (NYSE:LLY) announced a multi-million dollar investment to expand its existing biotechnology capabilities.

Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cancer therapies, is holding a conference call with the investment community tomorrow, Wednesday, June 29, 2011 at Noon Eastern (9:00 a.m. Pacific).

Hadasit Bio-Holdings, Ltd. - (OTCBB: HADSY), a publicly traded portfolio of biotech companies all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced that it has listed and begun trading of American Depository Receipts (ADR) through BNY Mellon.

HWI Global, Inc., (OTCBB: HWIC), the Pittsburgh-based clean room design builder reports constructing its Bio-Gard Germicidal Wall System as part of the ongoing Surgery Modernization project at Memorial Hospital in Gulfport, Mississippi.

Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that it has been added to the Russell 3000® Index following Russell Investments' reconstitution of its comprehensive set of U.S. and global equity indexes on June 24, 2011.

Medco Health Solutions, Inc. (NYSE:MHS) plans to announce its second-quarter 2011 financial results in a press release before the market opens on Thursday, July 21, 2011.

OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI), a biopharmaceutical company committed to the development and commercialization of new cancer therapies that address treatment resistance in cancer patients, announced today that the Company was added to the Russell Global Index, Russell 2000® Index, Russell 3000® Index and Russell Microcap® Index at the close of market on June 24, 2011 as part of the annual reconstitution of Russell indexes.

Pacific Biomarkers, Inc. (PBI) (OTCBB: PBMC), a provider of biomarker laboratory services to the pharmaceutical, biotechnology and diagnostics industries, is pleased to announce that Amar A. Sethi, MD, PhD, the Company's Vice President of Research and Development, has been named one of 30 emerging pharma leaders in the June 2011 issue of Pharmaceutical Executive.

Palatin Technologies, Inc. (NYSE Amex:PTN) announced today that enrollment of patients has commenced in Palatin's Phase 2b clinical trial evaluating the efficacy and safety of bremelanotide (previously called PT-141), an on-demand, first-in-class melanocortin agonist being developed for the treatment of female sexual dysfunction (FSD).

PharmAthene, Inc. (NYSE Amex:PIP) announced today that the Company was added to the Russell Global Index and the Russell 3000 Index when Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes on June 24, 2011.

QIAGEN N.V. (NASDAQ:QGEN) today announced that its common shares were added to the U.S. large-cap Russell 1000 Index and the broad-market Russell 3000 Index.

Savanna East Africa, Inc. (PINKSHEETS: NVAE) (OTCQB: NVAE) today posted a Webcast from CEO LTC Randell Torno reporting on the recent senior management and key stakeholder meetings held in Nairobi, Kenya.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that following the satisfaction of the closing conditions, including the expiry of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the acquisition of Advanced BioHealing, Inc. ("ABH"), as first announced on May 17, 2011, has been completed.

Therapeutic Solutions International, Inc. (OTCQB: TSOI) (PINKSHEETS: TSOI), the only manufacturer of the chairside NTI Tension Suppression System (NTI-tss) that has helped countless patients prevent debilitating migraine and tension headache pain, announced today the signing of a sales and distribution agreement with TWL Ltd., a dental supply company headquartered in Hong Kong and Cross Protection PTE, Ltd., a dental supply company headquartered in Singapore.

Zygo Corporation (NASDAQ: ZIGO), a worldwide supplier of optical metrology instruments and high precision optical systems, today announced that its Optical Systems Division has been awarded a multi-million dollar order from a major medical device manufacturer to produce high precision objective lens assemblies used in ophthalmic laser surgery.



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