Amylin's BYETTA® Approved for Use with Insulin Glargine; Alexion Raises FY 2011 Guidance Print E-mail
By Staff and Wire Reports   
Thursday, 20 October 2011 19:20
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 20, 2011.

Amylin Pharmaceuticals, Inc., (Nasdaq:AMLN)
and Eli Lilly and Company,  (NYSE:LLY), announced the FDA has approved a new use for BYETTA® (exenatide) injection. BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

"This expanded use for BYETTA is important for clinical care, in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "BYETTA is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using BYETTA with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using insulin glargine alone."

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Alexion Pharmaceuticals, Inc.(NASDAQ:ALXN)  announced its revenue guidance has been revised upward, from the previously announced range of $760 to $768 million, now to the higher range of $770 to $775 million.

The upward revision in revenue guidance reflects continued global growth of Soliris for PNH; no additional contribution is expected from aHUS operations beyond what had been included in earlier forecasts. Guidance for non-GAAP EPS is also being revised upward from the previous range of $1.15 to $1.20 now to the higher range of $1.25 to $1.28, based on a forecast of approximately 194 million diluted shares outstanding for the year. According to I/B/E/S Estimates, analysts were expecting the Company to report revenues of $767 million and EPS of $1.19 for fiscal 2011.




Also Thursday:




3SBio Inc. (NASDAQ: SSRX)
, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it will release its unaudited third quarter 2011 results after the NASDAQ stock market closes on Thursday, November 10, 2011 at 8:00pm (US Eastern).

Agilent Technologies Inc. (NYSE:A) and the University of Technology, Sydney, today announced the establishment of a joint nuclear magnetic resonance research facility.

Allied Healthcare International Inc. (NASDAQ: AHCI), a leading homecare provider of health and social care in the United Kingdom and Ireland, announced today the completion of its acquisition by Saga Group Limited pursuant to a merger agreement that was adopted by Allied's shareholders at a special meeting held on October 19, 2011.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the Newsmakers in the Biotech Industry 2011 Conference on Friday, October 21, 2011 at 10:30 a.m. ET at The Millennium Broadway Hotel in New York.

Amarantus BioSciences, Inc. (OTCBB: AMBS)
, a biotechnology company developing a first-in-class disease-modifying therapeutic protein that addresses an underlying form of cell death known as apoptosis, announced today that it has received a Notice of Allowance from the United States Patent & Trademark Office ("USPTO").

Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab).

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today provided an overview of selected studies that will be presented at the 49th Annual Infectious Diseases Society of America (IDSA) meeting taking place from October 20th to 23rd, 2011 in Boston.

Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company, today announced that it will report its financial results for the third quarter ended September 30, 2011.

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it will report financial results for the third quarter 2011 on Thursday, November 3, 2011, after market close.

Geron Corporation (Nasdaq: GERN) today announced two presentations on the company’s ongoing Phase 1 clinical trial of its human embryonic stem cell-based therapy, GRNOPC1, in patients with spinal cord injury.

Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced that it ranked number 47 on Technology Fast 500™, Deloitte's ranking of 500 of the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America.

IntelliCell BioSciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC) ("IntelliCell" or the "Company"), a leader in regenerative medicine and the manufacturing of stromal vascular fraction (SVF) containing adipose derived adult stem cells, announced today a study published regarding the efficacy of IntelliCell's proprietary SVF in the treatment of gum recession.

Marijuana, Inc. (PINKSHEETS: HEMP)
announced today the retention of Eric P. Littman, an attorney licensed to practice law in the state of Florida, to represent Marijuana, Inc.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from a 24-week interim analysis of an ongoing 48-week Phase IIb clinical study evaluating the investigational use of VICTRELIS™ (boceprevir), the company’s first-in-class, oral hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with peginterferon alfa and ribavirin for the treatment of chronic HCV genotype 1 infection in adult patients coinfected with HIV-1.

MiMedx Group, Inc.  (OTCBB: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its Chairman and CEO, Parker H. "Pete" Petit, has been inducted into the National Academy of Engineering.

mPhase Technologies, Inc. (OTCBB: XDSL)
said today that it has received patent no. 8,021,773 from the United States Patent Office for a battery system for efficiently operating a battery under various circumstances, such as relating to extreme temperature ranges and varying load (i.e. current) ranges.

NuVim, Inc. (PINKSHEETS: NUVM), a leading provider of nutritional refrigerated ready to drink beverages and powder mixes, announced today that the Wal-Mart Roll Back promotion that was scheduled to begin in June was delayed until September and will now run through December.

Oncothyreon Inc. (Nasdaq: ONTY) today announced it has initiated the Phase 2 portion of  its ongoing Phase 1/2 trial of PX-866 in combination with the chemotherapeutic agent docetaxel (Taxotere®)following successful completion of the Phase 1 dose escalation portion of the study.

PerkinElmer, Inc. (NYSE: PKI)
, a global leader focused on improving the health and safety of people and the environment, today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and clearance under Germany’s Act against Restraints of Competition (which was granted on October 10, 2011), in connection with its previously announced acquisition of Caliper Life Sciences, Inc.

PharmStar Pharmaceuticals, Inc. (PINKSHEETS: PHAR) announced that it has signed a commitment letter for a 3-year wholesale distribution agreement for its signature product line, Aquaprin.

Drug delivery company pSivida Corp. (NASDAQ:PSDV) (ASX:PVA) announced it ranked 59th on the Deloitte 2011 Technology Fast 500™, ranking of the 500 fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. pSivida grew at a rate of 2125 percent over the past five years.

Radient Pharmaceuticals Corporation "the Company" or "Radient" (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced that the lawsuits filed against Radient Pharmaceuticals regarding rights to its Combination Immune Technology (CIT) cancer vaccine technology have been dismissed.

Response Biomedical Corporation (TSX: RBM, OTCBB:RPBIF)
announced today the appointment Dr. David Wang of Orbimed Asia to the Board of Directors of Response Biomedical, the resignation of Dr. Jonathan Wang as a Director of Response Biomedical, and the promotion of two executives to leadership positions in the Company.

Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today new data from the pivotal TEriflunomide Multiple Sclerosis Oral (TEMSO) Phase III trial showing that once-daily oral teriflunomide significantly reduced annualized rates of relapses leading to hospitalization.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that it will release its third-quarter 2011 financial results before the market opens on Thursday, November 3, 2011.

TheDirectory.com, Inc. (PINKSHEETS: SEEK) today released call in details for its Investor Conference Call scheduled to take place after the market closes today.

Titan Pharmaceuticals, Inc. (OTCBB: TTNP)
today announced that Walter Ling, M.D. will make a presentation about Probuphine™ and prescription drug abuse at the American Society of Addiction Medicine (ASAM) State of the Art Course in Addiction Medicine on October 27, 2011 at 4 p.m. ET in Washington DC.

United Therapeutics Corporation (NASDAQ:UTHR) announced today that it will release its third quarter 2011 financial results before market open on Thursday, October 27, 2011.

Unigene Laboratories, Inc. (OTCBB: UGNE)
, a leader in the design, delivery, manufacture and development of peptide-based therapeutics, announced today that all patients have completed the course of therapy in the Phase 2 study of an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women.

VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (PINK SHEETS:VPTDF) is pleased to announce the installation of its VentriPoint Medical System (VMS™) at the Manchester Heart Centre at the Central Manchester University Hospitals NHS Foundation Trust, in Manchester UK.

Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company developing and commercializing high-performance enzymes, today announced that it has entered into an agreement with Comerica Bank and the Export-Import Bank of the United States ("Ex-Im Bank") for two 18-month, secured revolving credit facilities totaling up to $13 million.



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