Roche Says HIV 1 Viral Load Test Now Available in US; Celgene Says No ODAC Meeting November 8, 2012 Print E-mail
By Staff and Wire Reports   
Wednesday, 03 October 2012 19:27
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 3, 2012.

Roche (OTC: RHHBY)
announced today the U.S. availability of a new HIV-1 viral load test based on the company's proprietary dual-target approach. The COBAS TaqMan HIV-1 Test v2.0 for use with the High Pure System enables labs to combine an FDA-approved process for manual specimen preparation with an automated real-time PCR analyzer for amplification and detection.


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Celgene Corporation (NASDAQ: CELG)
announced it was notified by the U.S. FDA that there will not be an Oncologic Drugs Advisory Committee (“ODAC”) meeting scheduled for November 8, 2012. The agency has informed the Company the review of its new drug application (“NDA”) for pomalidomide is continuing with the previously announced Prescription Drug User Fee Act (PDUFA) action date remaining Feb. 10, 2013.

The Company is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed and refractory multiple myeloma that has progressed following at least two prior therapies.



Also Wednesday:




Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that the issued and outstanding common shares of the Company ("Common Shares") have been consolidated (the "Consolidation") on a six (6) to one (1) basis effective as of October 2, 2012.

Aethlon Medical, Inc. (OTCBB: AEMD)
, today released the slide-deck underlying a presentation given yesterday by its Chairman and CEO, Jim Joyce at the EXOSOMES & MICROVESICLES 2012 conference in Orlando, Florida.

Amarantus BioSciences, Inc. (OTCQB: AMBS)
, a biotechnology company developing new treatments for brain-related disorders including Parkinson's disease and Traumatic Brain Injuries (TBI) centered on its unique proprietary anti-apoptotic therapeutic protein known as MANF, today announced the commitment by former Minnesota Vikings Pro Bowl linebacker E.J. Henderson to support the further development of Amarantus' TBI research collaboration with Banyan Biomarkers.

Antares Pharma, Inc. (NASDAQ: ATRS) today announced that it has priced a firm commitment underwritten public offering of 12,500,000 shares of the Company’s common stock at a purchase price to the public of $4.00 per share, resulting in net proceeds to the Company of $47 million (before estimated offering expenses payable by us).

The Aristocrat Group Corp. (OTCBB: ASCC)
announced today that it received testing samples of a revolutionary new biomolecule face cream that could hold the key to younger-looking skin.

AVEO Oncology (NASDAQ: AVEO)
today announced that new clinical data on its lead product candidate tivozanib, partnered with Astellas Pharma Inc. (TSE: 4503), as well as its HGF inhibitory antibody ficlatuzumab will be presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria, September 28 – October 2, 2012.

China Cord Blood Corporation (NYSE: CO)
("CCBC" or the "Company"), the first and largest cord blood banking operator in China, announced that it has successfully completed the previously announced $50 million convertible note financing with Golden Meditech Holdings Limited ("Golden Meditech", 801.HK; 910801.TW), a leading integrated healthcare enterprise in China and the Company's largest shareholder.

Covidien plc (NYSE: COV)
will report fourth-quarter results on November 9, 2012, before trading begins.

Derma Sciences, Inc. (Nasdaq: DSCI)
, a medical device and pharmaceutical company focused on advanced wound care, today reported an independent pilot study conducted in the U.K. showed that MEDIHONEY® may reduce the length of hospital stays by encouraging more rapid healing.

Dr. Reddy’s Laboratories (NYSE: RDY)
announced today that is has launched Amoxicillin Tablets, Capsules, and Oral Suspension, a bioequivalent generic version of Amoxil® (Amoxicillin) Tablets, Capsules, and Oral Suspension in the US Market on September 17, 2012.

Elan Corporation, plc (NYSE:ELN)
today announced the appointment of Hans Peter Hasler as Chief Operating Officer (“COO”) of the Company with effect from October 1, 2012.

iBio, Inc. (NYSE MKT: IBIO)
today announced issuance of a U.S. patent covering compositions of matter and methods of producing and formulating anthrax vaccines.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
and Almirall, S.A. (ALM:MC) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing approval for Constella® (linaclotide 290 micrograms), for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced Phase IIb data for MK-3102, the company’s investigational once-weekly DPP-4 inhibitor in development for the treatment of type 2 diabetes.

Omeros Corporation (NASDAQ: OMER)
today announced that the last patient has been enrolled in the Company's second Phase 3 clinical trial evaluating OMS302 for use during intraocular lens replacement (ILR) surgery.

Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB)
(http://www.oramed.com), a developer of oral drug delivery systems, announced today that its subsidiary, Oramed Ltd., has signed an agreement with Medpace, Inc. to retain Medpace as a Clinical Research Organization (CRO) for Oramed's upcoming Phase II clinical trial on its oral insulin capsule, ORMD-0801.

Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT)
is pleased to report that the U.S. Navy plans to initiate preclinical studies to investigate the potential use of OBI’s proprietary perfluorocarbon emulsion, Oxycyte®, as an intravenously delivered adjunctive treatment for complex infected wounds and related injuries.

Pegasystems Inc. (NASDAQ: PEGA)
, the leader in Business Process Management (BPM) and a leading provider of Customer Relationship Management (CRM) solutions, today announced that it will host the Second Annual Collaborative Healthcare Summit on October 24, 2012 at the Park Plaza Hotel in Boston.

Repligen Corporation (NASDAQ:RGEN)
today announced the appointment of Jonathan I. Lieber to the position of Chief Financial Officer and Treasurer, effective immediately.

PROLOR Biotech, Inc. (NYSE MKT: PBTH)
today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP).

PURE Bioscience, Inc. (NASDAQ: PURE)
, the creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced it has initiated testing of SDC-based formulas in direct food applications to determine efficacy in reducing food borne pathogens such as Listeria, E. coli and Salmonella.

Rocky® and Durango®, divisions of Rocky Brands (NASDAQ: RCKY), are giving breast cancer the boot with new footwear styles designed to promote breast cancer awareness.

Sanofi (EURONEXT: SAN and NYSE: SNY)
and Bristol-Myers Squibb Company (NYSE: BMY) today announced they have restructured their successful long-term alliance following the loss of exclusivity of Plavix® and Avapro®/Avalide® in many major markets.

Sigma-Aldrich® Corporation (Nasdaq: SIAL)
announced today that Sigma Life Science, its innovative biological products and services research business, has launched Stemline® Pluripotent Culture Medium, a novel human pluripotent stem cell culture medium that provides a consistent environment for the long-term maintenance and growth of healthy pluripotent stem cells.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a development stage biopharmaceutical company, announced today the formation of a Scientific Advisory Board (SAB) to provide strategic guidance to the Company as it relates to the development of OrbeShield™ (oral beclomethasone dipropionate, or oral BDP) for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).

TelVue® Corporation (OTCQB: TEVE)
, the innovation leader in Television and Internet Broadcasting for media companies, cable operators and communities, is proud to be powering VIZ Media's launch of Neon Alley, a new 24-hour programmed anime channel available exclusively on a popular Internet connected gaming system.

Vanderbilt University and Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have signed a collaboration agreement for the discovery, development and commercialization of novel therapies acting on the mGluR4 glutamate receptor, known as positive allosteric modulators or PAMs, for the treatment of Parkinson’s disease.

Walgreens (NYSE: WAG) (Nasdaq: WAG)
had September sales of $5.48 billion, a decrease of 7.8 percent from $5.94 billion for the same month in fiscal 2012.



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