FDA Reviews Bristol/Pfizer's Eliquis; Onyx Announces FDA Acceptance of New Drug Application for Carfilzomib Print E-mail
By Staff and Wire Reports   
Tuesday, 29 November 2011 18:59
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 29, 2011.

Eliquis, a promising new drug from Bristol-Myers Squibb Co (NYSE:BMY) and Pfizer Inc , (NYSE:PFE), shown to be better than warfarin at preventing strokes in patients with a dangerously irregular heartbeat may reach the U.S. market more quickly after health regulators gave it an expedited review. Bristol-Myers Squibb Co and Pfizer Inc , would be the third new U.S. treatment for these patients after Xarelto, from Bayer and Johnson & Johnson , was approved earlier this month, and Pradaxa from Boehringer Ingelheim was approved last year.

The U.S. Food and Drug Administration typically takes 10 months or longer to review new drug applications but will give Eliquis a quicker review after clinical trials showed the drug was safer and more effective than decades-old warfarin.

The FDA is expected to give a decision on approval by March 28, Bristol and Pfizer said. That would close the gap in the three-way race, as the new treatments compete in an estimated $10 billion market.

Many industry watchers had expected Xarelto to have a full year on the market before facing competition from Eliquis. But some analysts told Reuters earlier this month that the FDA had a good case for accelerating its review of Eliquis.

Many patients are unwilling or unable to take warfarin because of dietary requirements, bleeding risk, conflicts with other medicines and the need for regular testing to ensure the right concentrations of warfarin are in the bloodstream.

ISI Group analyst Mark Schoenebaum said he expects Eliquis to become the dominant player in the atrial fibrillation market.

Anthony Butler, an analyst with Barclays, said Eliquis remains his pick for the top selling oral anticoagulant in the next decade.

Deutsche Bank analyst Barbara Ryan said peak sales of Eliquis could top $2.5 billion.

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Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced the FDA has accepted the New Drug Application (NDA) submission for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

"The FDA's acceptance of the new drug application submission for carfilzomib marks an important milestone for bringing this promising therapy one step closer to patients with few remaining treatment options," said Ted Love, M.D., executive vice president, research and development and technical operations at Onyx Pharmaceuticals. "We believe that the efficacy and safety data make carfilzomib an appropriate candidate for accelerated approval in the relapsed and refractory treatment setting, and we look forward to hearing back from the FDA in the next few weeks regarding priority versus standard review."



Also Tuesday:



Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the European Commission (EC) has extended the therapeutic indication for Soliris® (eculizumab) to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the third quarter ending September 30, 2011.

China Health Resource, Inc. (OTCBB: CHRI)
, through its wholly owned subsidiary Suining Yinfa DAR Industrial Co, Ltd (Yinfa), announces it active participation at "HOW TO BECOME A GLOBAL COMPANY NOW THROUGH ACQUISITION!Business and Legal Strategies for Chinese Companies Going Global"sponsored by Boss & Young, EvoTech Management Corporation and Loeb & Loeb LLP, a seminar held in Shanghai, PRC.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, today announced study data demonstrating that use of its Endo Stitch™ automated suturing device lowers mean hospital costs and operating room (OR) time during total laparoscopic hysterectomies treating benign conditions.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that company management will present at investor conferences during December 2011 to discuss the company’s business activities, financial outlook, and current news.

EMC Corporation (NYSE: EMC)
today announced that Ambry Genetics®, a leading commercial provider of clinical diagnostic and genomic services, has deployed EMC® Isilon® scale-out NAS to power its advanced gene sequencing operations, enabling Ambry to advance a range of scientific pursuits while easily managing 100 percent data growth annually.

Horizon Pharma, Inc. (NASDAQ: HZNP)
today announced that the United States Food and Drug Administration (FDA) has accepted for filing and review its New Drug Application (NDA) for LODOTRA®, a proprietary modified (delayed)-release formulation of low-dose prednisone, for the treatment of rheumatoid arthritis (RA) in adults, and set a PDUFA date of July 26, 2012, based on the standard 10 month review. LODOTRA is currently approved for marketing in 16 European countries.

Infinity Pharmaceuticals, Inc. (Nasdaq: INFI)
today announced that Mundipharma International Corporation Limited has committed to providing over $50 million in funding in 2013 for the continued development of IPI-145, Infinity’s potent, oral inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma, as well as development candidates arising out of Infinity’s innovative discovery programs.

Inhibitex, Inc. (NASDAQ:INHX)
(the “Company”) today announced several recent clinical and corporate developments, including top-line safety and antiviral data from its ongoing clinical trial designed to evaluate additional doses of INX-189, an oral nucleotide polymerase inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV), administered as monotherapy or in combination with ribavirin (RBV) for seven days.

IsoRay, Inc. (AMEX: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer, lung cancer, head and neck cancer and prostate cancer today announced that Dwight Babcock, Chairman and Chief Executive Officer, will co-present at RetailInvestorConferences.com.

Marina Biotech, Inc. (NASDAQ: MRNA)
, a leading oligonucleotide-based drug discovery and development company, today announced that the Marina/Debiopharm Research and Development (R&D) Team has selected and confirmed the lead DiLA2formulation for a RNAi-based therapy for the treatment of non-muscle invasive bladder cancer.

NewCardio, Inc., (OTC BB: NWCI)
a cardiovascular diagnostic solutions developer, announced today that a top 3 Clinical Research Organization (CRO) will utilize QTinno®, automated cardiac safety solution, to support a Phase I drug safety study for a biopharmaceutical sponsor.

NeuroMetrix, Inc. (Nasdaq: NURO)
, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today announced that Shai N. Gozani M.D., Ph.D., President and Chief Executive Officer, is scheduled to speak at the Canaccord Genuity 6th Annual Cardiovascular, Aesthetics & Metabolic Disorders Conference at the St. Regis Hotel, San Francisco, CA on December 6, 2011.

Perceptive Informatics®, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that its DataLabs® Electronic Data Capture (EDC) solution ranked highest among EDC solutions for overall satisfaction in ISR's 2011 The State of The EDC Market Report, an independent study conducted by Industry Standard Research (ISR).

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, has held its third end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”).

Roche (SIX: RO, ROG; OTCQX: RHHBY), PTC Therapeutics, Inc. (PTC) and the SMA Foundation, announced today a licensing agreement for PTC's Spinal Muscular Atrophy (SMA) programme. SMA is a genetic neuromuscular disorder that causes muscle weakness.

Royal Philips Electronics (AEX: PHI, NYSE: PHG) today announced installations of MicroDose, its new full-field digital mammography (FFDM) solution, at four customer sites in North America, bringing clinicians uncompromised image quality at a low radiation dose.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at The Oppenheimer 22nd Annual Healthcare Conference in New York, NY on Tuesday, December 13, 2011 at 1:35 p.m. ET.

Unilife Corporation (NASDAQ: UNIS; ASX: UNS) today announced the signing of a clinical development and supply agreement with a global pharmaceutical company for a novel device for targeted organ delivery.

Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma, has recently introduced several new products for use of an individual’s own cells (http://tinyurl.com/78n2oe2) for various therapeutic applications.

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol), a generic version of Bayer's Yaz(R) oral contraceptive product.



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