EU pulls plug on Glaxo's Avandia, Edwards shares soar on heart valve data. FDA approves Bionovo plan, shares rocket Print E-mail
By Mary Davila   
Thursday, 23 September 2010 19:02

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 23, 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate, Menerba®, in a Type "B" or "End of Phase 2" meeting. With this designation, the decisions and agreements are now considered binding on the Company and the FDA.

"This CMC approval represents a revolutionary set of 'firsts'," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "This is the first time that the FDA's botanical drug development CMC guidance has been applied to an oral drug in a major indication. This is also the first time in recent history that the FDA has reviewed and approved a manufacturing plan for a drug with multiple actives derived from botanical source. In addition, Menerba, may be the first in class selective estrogen receptor beta modulator to go into late stage development. After long effort, innovations and interaction, Bionovo has now opened the door for a new paradigm in drug development."

With the FDA's approval of the Company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trials in the U.S. Having just successfully concluded a non-binding teleconference with the FDA, the Company has requested a face-to-face meeting, for the approval of the clinical development plan. The FDA is expected to grant such a meeting shortly.

Shares of Bionovo shot up more than 56%, rising 69 cents to $1.91.


EU pulls plug on Glaxo's Avandia, FDA restricts - European officials moved to pull GlaxoSmithKline's (GSK.L) diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine.  Once a top treatment choice and Glaxo's No. 2 seller, the rulings attempted to resolve a bitter, three-year debate over Avandia's safety that has dogged the reputation of the medicine and its maker, and divided staff inside the U.S. Food and Drug Administration.  

The moves cleared the way for newer diabetes treatments to gain market share. Merck & Co's (MRK.N) drug Januvia and AstraZeneca Plc (AZN.L) and Bristol-Myers Squibb Co's (BMY.N) Onglyza were most likely to see a boost, analysts said.  In coordinated statements, the FDA in Washington and the European Medicines Agency (EMA) in London said they agreed on the heart risks associated with the drug but had reached different conclusions on action.  

The EMA said it would move to ensure Avandia was off the market in the next few months, while the FDA will require that U.S. patients first try other medicines to control blood sugar and acknowledge that they understand Avandia's risks.

Edwards shares soar on heart valve data - Shares of Edwards LifeSciences Corp (EW.N) jumped 13 percent on positive results from a closely watched study of its new heart valve that could spare patients open-heart surgery, paving the way for the first U.S. approval of the technology.  The New England Journal of Medicine published results late on Wednesday for the company's Sapien aortic valve, which is implanted using a less-invasive alternative to open-heart surgery.

The data are also being presented at a major medical conference on Thursday.  Patients in the study were too sick to endure an open-heart procedure, and half were expected to die within two years.  "The results ... bode well for the approval of Sapien in the U.S. and for the rapid uptake of the device," said Wells Fargo Securities analyst Larry Biegelsen in a note to clients.  The 358-patient trial, Cohort B of Edwards' Partner study, studied the valve for the treatment of severe aortic stenosis, a narrowing of the valve.

It met both of the clinical trial's main goals, Edwards said. "We are hard-pressed to find many faults with these data," William Blair analyst Ben Andrew said in a research note.  The Sapien valve has been sold in Europe since 2007. The valve is threaded through arteries to the heart with a catheter inserted either in the groin or through a small incision between the rib cage, avoiding the need for open-heart surgery in which the heart is stopped.

Also Thursday:


Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that Novartis has notified Alnylam that they have formally selected their full and final list of 31 targets, for which they have exclusive rights to discover, develop, and commercialize RNAi therapeutics using Alnylam intellectual property and technology.

AmerisourceBergen Corporation (NYSE:ABC) today reported that in its fiscal year 2010 third quarter ended June 30, 2010, diluted earnings per share were $0.57, 36 percent increase, which includes a $0.05 benefit from special items.

Biomagnetics Diagnostics Corp. (PINK SHEETS:BMGP), a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, recently announced its formal signing of a merger agreement between Biomagnetics Diagnostics Crop. and Hubei Tianyuan Chemical Co., Ltd.

Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, will host a conference call on Wednesday, September 29, 2010, at 11:00 a.m.

The Board of Directors of AmerisourceBergen Corporation (NYSE:ABC) today authorized a new $500 million share repurchase program, effective after completion of the current repurchase program, which has approximately $98 million remaining.

Corgenix Medical Corporation (OTC Bulletin Board:CONX), a worldwide developer and marketer of diagnostic test kits, today filed its fiscal year Form 10-K and reported financial results.

Covidien (NYSE: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, today announced that the Puritan Bennett™ 560 ventilator is now available in Europe.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX)
today announced that Caldolor® (ibuprofen) Injection is gaining momentum and being approved for use in a growing number of medical facilities across the country.

CytoGenix, Inc. (Pink Sheets:CYGX)
announced that today its Board of Directors voted unanimously to move its Corporate Headquarters to New York, NY.

Dr. Reddy’s Laboratories Limited (NYSE: RDY) today announced that its Annual Report on Form 20-F, containing its annual consolidated financial statements for the fiscal year ended 31 March, 2010 was filed with the United States Securities and Exchange Commission.

Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has begun to immunize subjects in a Phase 1b clinical trial of its Universal Flu Vaccine candidate.

Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP), a biotechnology company developing targeted cancer therapies, today announced that it has closed a private offering pursuant to which it entered into definitive agreements with accredited investors to purchase 933,341 shares of its common stock at a purchase price of $0.75 per share, together with Series A warrants to purchase 466,674 shares at an exercise price of $1.00 per share, and Series B warrants to purchase 466,674 shares at $1.25 per share.  

GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.  

HeartWare International, Inc. (Nasdaq:HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Lazard Capital Markets Second Annual Circulatory Assist Device Day from 2:00-3:00 pm EDT on Wednesday, September 29.  

Huifeng Bio-Pharmaceutical Technology, Inc. (OTC Bulletin Board:HFGB) ("the Company"), specializing in developing and producing botanical extracts and other raw materials for pharmaceuticals and food additives, today announced the reinspection approval of Good Manufacturing Practice ("GMP") certificate by the State Food and Drug Administration (SFDA) on September 7, 2010.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio scientists and collaborators of the company will present immune response and other important data for several of its DNA vaccines for infectious diseases at three major global vaccine conferences in late September and early October, 2010.

Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the U.S. Food and Drug Administration (FDA) conditionally approved the first of two planned cohorts of the randomized, controlled The PARTNER II Trial.

Martek Biosciences Corporation (Nasdaq:MATK) announced today that it has entered into an agreement to sell a significant portion of the assets at its Winchester, Ky., manufacturing site to Alltech, an animal health company headquartered in Nicholasville, Ky.

Medical Marijuana Inc (PINKSHEETS:MJNA) proudly announces that The Hemp Network® (www.thehempnetwork.com) division has successfully entered the next phase of pre-launch.

Medizone International, Inc. (OTCQB: MZEI) announced today the Company has filed a fourth U.S. Provisional patent application involving what it terms, "Advanced Oxidative Sterilization Processes."

PAREXEL International Corporation (Nasdaq:PRXL) will release First Quarter Fiscal Year 2011 financial results on Monday, November 1, 2010 after the close of the stock market.

PLC Systems Inc. (OTC Bulletin Board:PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard® in Italy showed that RenalGuard was more effective than the current standard of care at preventing Contrast Induced-Nephropathy (CIN).

TheraBiogen, Inc. (OTCBB: TRAB) announced today that it has shipped its first order of its TheraMax® Cold & Flu and TheraMax® Allergy relief sprays and has received additional orders for those nasal spray products from Rite Aid corporation with nationwide distribution for retail sales of the products during the Fall cold and flu season.

Vermillion, Inc. (Nasdaq:VRML), a molecular diagnostics company, today announced the appointment of Jeffrey M. Salzman as Corporate Director of Reimbursement.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has entered into an agreement to sell $375.0 million aggregate principal amount of 3.35% convertible senior subordinated notes due 2015.

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today reported operational and financial results for its fiscal year end, ended June 30, 2010.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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