Vertex Announces Health Canada Approves INCIVEK. FDA Aims For April Decision On Amgen's Xgeva. Print E-mail
By Staff and Wire Reports   
Monday, 22 August 2011 18:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 22, 2011.

Vertex Pharmaceuticals, Inc. (NASDAQ:VRTX) announced Health Canada has approved INCIVEK (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver).

INCIVEK is approved for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure). INCIVEK is approved for use in all three major groups of people who did not achieve a viral cure despite prior treatment including: relapsers, partial responders and null responders.

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Dow Jones reported that Amgen, Inc. (NASDAQ:AMGN) said the FDA is aiming for next April to decide whether to approve its bone cancer drug to help reduce the risk of a type of prostate cancer from spreading to the bone.

Amgen, which faces numerous pressures from rising competition and regulatory issues related to its aging portfolio of drugs, has been looking at Xgeva's various uses to invigorate its profit growth. The Company in December reported Xgeva helped delay the spread of prostate cancer to bone by 4.2 months in key late-stage data that may open up a new use for the potential blockbuster drug.


Also Monday:


Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced today the appointment of Brian S. Posner to its Board of Directors.

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced that the commercial launch and availability of ONSOLIS (fentanyl buccal soluble film) in Canada will take place this quarter.

BioRestorative Therapies, Inc. (OTCQB: SCLZ) (the "Company") today announced that, based upon the Company's filing of its Quarterly Report on Form 10-Q with the Securities and Exchange Commission, the Company's common stock is now being traded on the OTCQB market, the middle tier of the OTC Market, which has been established for companies that are subject to the reporting requirements of the SEC, instead of on the OTC Pink market, the lowest tier of the OTC Market.

Cephalon, Inc. (Nasdaq:CEPH) today provided notice to holders of its 2.50 percent Convertible Senior Subordinated Notes due 2014 (the "2014 Notes") and 2.00 percent Convertible Senior Subordinated Notes due 2015 (the "2015 Notes") in respect of the Merger (as defined below) of the Company with a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., an Israeli corporation ("Parent"), the consummation of which will constitute a Fundamental Change under each of the Indenture governing the 2014 Notes (the "2014 Indenture") and the Indenture governing the 2015 Notes (the "2015 Indenture").

D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMED) ("D. Medical"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, expects to announce its fiscal 2011 second quarter financial results on Wednesday, August 31, 2011.

Today, www.EquityMarketsInc.com announced its research report highlighting Merck & Co., Inc. (NYSE: MRK) and The Procter & Gamble Company (NYSE: PG).

HDS International Corp. (OTCQB:  HDSI), a provider of industrial ocean-based biomass production and other high-value eco-sustainability solutions, today discussed the market opportunity associated with its carbon sequestration technologies.

Healthnostics, Inc. (PINKSHEETS: HNSS) will launch MicroFill-2160 at MinnPak, "the packaging and processing solutions Industry trade fair," and the concurrent Medical Design & Manufacturing shows at the Minneapolis Convention Center on November 2-3, 2011.

Medizone International, Inc. (OTCBB: MZEI) (OTCQB: MZEI) announced today that the introductory launch and subsequent product sales (at FIME) of its AJIC peer-reviewed disinfection, and hospital infection control system -- AsepticSureā„¢ -- was an unprecedented success.

Neogen Corporation (Nasdaq:NEOG) has announced that its GeneSeek subsidiary is a participant in USDA-funded research that seeks to better understand the role cattle genetics may play in food contamination by the pathogen E. coli O157:H7.

ShangPharma Corporation (NYSE:SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its unaudited financial results for the quarter ended June 30, 2011.

TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that it will be reducing its outstanding debt level by an additional $350,000 next week.



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