FDA seeks more data on diabetes drug. Boehringer winner in blood-thinner race. Print E-mail
By Mary Davila   
Tuesday, 19 October 2010 19:37

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 19, 2010.

FDA seeks more data on Amylin, Lilly diabetes drug - The diabetes drug Bydureon, being developed by Amylin Pharmaceuticals Inc's (NASDAQ:AMLN) and Eli Lilly and Co (NYSE:LLY), has been declined on Tuesday by U.S. health regulators citing the need for further studies, including the drug's effect on heart rate.

The companies said they will reply to the FDA by the end of next year. They expect the next review of the drug could come by mid-2012.

Shares of Amylin, which fell 3.4 percent in regular trading, were halted after hours. Shares of Lilly were down 2.5 percent after hours at $36.50.

Analysts have projected annual sales of over $1 billion if Bydureon is approved by regulators.

The FDA requested in a "complete response letter" a thorough study of the impact of the drug's main component, exenatide, on heart muscle, Amylin and Lilly said in a statement. The FDA has also has requested results from an ongoing study of the drug.


Boehringer wins first US OK in blood-thinner race - German drugmaker Boehringer Ingelheim has been given the first U.S. approval for Pradaxa, a new stroke-fighting medicine, that will compete in an estimated $10 billion market for drugs to replace the 65-year-old blood thinner warfarin.

The FDA cleared Boehringer's drug, Pradaxa, for preventing strokes in patients with a type of irregular heart beat.

The approval gives Boehringer a head start over several other drugmakers, including partners Bayer (XETRA:BAYN.DE) and Johnson & Johnson (NYSE:JNJ), and Bristol-Myers Squibb Co (NYSE:BMY) and Pfizer (NYSE:PFE), that are working on competing drugs.



Here are other companies that made news on Tuesday:


Aethlon Medical, Inc. (OTC Bulletin Board:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that Rod Kenley has been appointed to the Aethlon Medical board of directors.

Applied Visual Sciences (OTCBB: APVS) announced today that, on October 15, 2010, it entered into an agreement with the holders of the company's outstanding Series A 10% Senior Convertible Debentures due November 7, 2008, that extends the maturity date of the debentures, provides that the debentures will be non-interest bearing through the date of maturity, and for certain other amendments to the terms of the debentures and related agreements.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia.
First China Pharmaceutical Group, Inc. (OTCBB: FCPG) ("First China" or the "Company") is pleased to announce it has recently signed agreements to distribute medicinal and pharmaceutical products to three district hospitals in Yunnan Province, thereby dramatically increasing its regional market share.

Codexis, Inc. (Nasdaq:CDXS) today announced the company will participate in the Goldman Sachs Fifth Annual Clean Energy Conference in New York, NY on November 10-11, 2010.

Generex Biotechnology Corporation (OTCQB:GNBT) (www.generex.com) announced today that on October 19, 2010 the NASDAQ Listing Qualifications Panel notified the Company that the Panel has determined to delist the Company's common stock from the NASDAQ Capital Market and will suspend trading of the stock effective at the open of trading on Thursday, October 21, 2010 as a consequence of the Company's non-compliance with NASDAQ's minimum $1.00 per share closing bid price requirement.

InfuSystem Holdings, Inc. (OTCBB:INHI), a leading provider of infusion pumps and associated products and services, announced the completion of its public offering of 2.8 million shares of common stock.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at BioCentury's NewsMakers in the Biotech Industry Conference, being held at the Millennium Broadway Hotel and Conference Center in New York City.

Lotus Pharmaceuticals, Inc. (OTC Bulletin Board:LTUS) ("Lotus" or the "Company"), a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), announced today that its wholly owned subsidiary, En Ze Jia Shi Pharmaceuticals, has been issued a patent by the State Intellectual Property Office of the People's Republic of China for controlled-release oral gliclazide.

Masimo (Nasdaq:MASI) announced today that a new randomized controlled trial shows that the Masimo noninvasive and continuous hemoglobin (SpHb®) monitor helped anesthesiologists reduce the frequency of blood transfusion by 86% in patients undergoing orthopedic surgery.

Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI), this week presented data from a preclinical study that indicate Trofex™ (123I-MIP-1072), its lead molecular imaging candidate for the detection of metastatic prostate cancer, may also be used to visualize changes in tumor volume in response to treatment of the disease.

Medivation, Inc. (Nasdaq:MDVN) today announced that David Hung, M.D., president and chief executive officer, will present at the 17th Annual NewsMakers in the Biotech Industry Conference on Friday, October 22, at 10:00 a.m. Eastern Time at the Millennium Broadway Hotel & Conference Center in New York.

MMRGlobal, Inc. (OTCBB: MMRF) (MMR) today announced that it has entered into an agreement with Chartis to offer its energy casualty clients a suite of secure, online products that will allow their employees to manage critical, sensitive information such as medical, financial and vital records.

MELA Sciences, Inc. (NASDAQ: MELA) today announced that the results of the company's MelaFind® pivotal trial and pilot reader study have been published in the online edition of the journal Archives of Dermatology.

MultiCell Technologies, Inc. (OTC Bulletin Board:MCET) and its majority owned subsidiary, Xenogenics Corporation, are pleased to announce the acquisition of the Ideal™ BioStent assets by Xenogenics Corporation from investment funds managed by Western Technology Investment and Silicon Valley Bank.  

OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) today announced that it has priced a public offering of 3,174,602 units, with each unit consisting of one share of the Company's common stock and one-half (1/2) of one warrant, at a purchase price of $15.75 per unit for an aggreate offering amount of $50 million.

Protectus Medical Devices, Inc. (OTCQB:PTMD) (PINKSHEETS: PTMD), a developer and marketer of innovative safety medical devices, announces that the Company's CEO Dr. John Salstrom, will begin a series of one-on-one interviews with OTC Voice.com

Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that it will release financial results for the third quarter ended September 30, 2010 on Thursday, October 28, 2010 after the market close.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) and its exclusive India-based distribution partner Jaiva Technologies, Inc. (JTI) and Jaiva's Indian subsidiary Gaur Diagno, Pvt Ltd (GDL) announced today the launch of a cancer education and screening program in India -- a key international market where GDL is actively commercializing RPC's Onko-Sure® in vitro diagnostic (IVD) cancer test.

Regenicin, Inc. (OTC Bulletin Board:WDST), a development stage biotechnology company, announced today that they have begun identifying candidates for the formation of a Scientific Advisory Board.

Savanna East Africa, Inc. (PINKSHEETS:NVAE) (OTCQB: NVAE) is scheduled to be featured in a Greenfield Partnership Program Webcast this Friday, October 22.

Stem Cell Assurance, Inc. (Pink Sheets:SCLZ) announced today the appointment of Mark Weinreb as Chief Executive Officer and as a member of the Company's Board of Directors.

Tengion Inc. (Nasdaq:TNGN), a leader in regenerative medicine, today announced that it has appointed Richard E. Kuntz, MD, M.Sc., Senior Vice President and Chief Scientific, Clinical and Regulatory Officer of Medtronic, Inc. (NYSE:MDT), to its Board of Directors.

ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today it has entered into a license and distribution agreement for its Res-Q™ 60 BMC (Res-Q) System with BioParadox, Inc., a newly-formed regenerative medicine company focusing on point-of-care cardiovascular therapies.

TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for cancer care, announced today that its 2010 third quarter earnings conference call, originally scheduled for Thursday, October 28, 2010 at 4:00 p.m. CDT, has been rescheduled for one day earlier, to Wednesday, October 27, 2010 at 4:00 p.m. CDT.

W. R. Grace & Co. (NYSE:GRA) has received approval from the United States Bankruptcy Court for the District of Delaware of the previously announced transactions contemplated by the Agreement and Plan of Merger dated as of September 13, 2010 pursuant to which W. R. Grace & Co.-Conn, a wholly-owned subsidiary of W. R. Grace & Co., will purchase Synthetech, Inc. (OTC Bulletin Board:NZYM), a manufacturer of fine chemicals specializing in organic synthesis, biocatalysis and chiral technologies.




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