FDA panel rejects Novartis drug Print E-mail
By Staff and Wire Reports   
Tuesday, 21 June 2011 20:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 21, 2011.

The FDA voted 11-1 rejecting Ilarisa, the proposed trade name, a Novartis AG (NYSE:NVS) drug for gout over concerns about side effects, a setback for the company's efforts to expand use of the medicine.

A committee of Food and Drug Administration advisers voted 11-1 against recommending approval of the drug for treating attacks of gout, a common form of inflammatory arthritis that affects about 8.3 million U.S. adults.

The panel also unanimously voted against the drug for delaying and reducing the frequency of future attacks.

Most advisers said the drug was effective in company studies but it was also linked to higher rates of serious infections and other potential side effects.

Advisers also focused on the lack of long-term data. In a company study, out of 454 patients only 43 had three or more injections of Ilaris, making it difficult to measure the effects of the drug over time.

Ilaris, which blocks a protein that is thought to increase inflammation, is already sold for treating a rare inflammatory disorder. Novartis had predicted the drug could generate blockbuster sales if it won clearance for gout and juvenile rheumatoid arthritis.

The FDA usually follows panel recommendations. The agency is due to make a decision on the drug by year-end, Novartis said.


Also Tuesday:


Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has entered into a definitive collaborative agreement with Roslin Cells LTD ("Roslin Cells") of Scotland.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that it is set to join the Russell Global Index when Russell Investments reconstitutes its comprehensive set of global equity indexes on June 24, 2011, according to a preliminary list of additions posted June 10, 2011, available at www.russell.com/indexes.

BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer and manufacturer of clinical grade biopreservation media products for cells and tissues, today announced that it has become the leading supplier of pre-formulated GMP cryopreservation media for umbilical cord blood stem cells, a key segment of the Company's strategic biobanking market.

BioStar Pharmaceuticals, Inc. (NASDAQ GM: BSPM) ("BioStar" or "the Company"), a Xianyang-based manufacturer of a leading PRC over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsules and a variety of pharmaceutical products, today announced that Mr. Ronghua Wang, Chief Executive Officer and Chairman of the Board of Directors of the Company, and Mr. Zack Pan, Chief Financial Officer of the Company, will attend the Brean Murray, Carret & Co 2011 Beijing China Growth Conference on June 27-28, 2011 at the JW Marriott Hotel, Beijing, China.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG)
("First China" or the "Company") is pleased to advise that the proposed acquisition of 100% of the interests of Shenzhen Ming He Tang Pharmaceutical Co., Ltd. ("Min He Tang") of Shenzhen City, Guangdong Province continues to move ahead.

Luminex Corporation (NASDAQ:LMNX) today announced a definitive agreement to acquire privately-held EraGen Biosciences, Inc., an innovator in molecular diagnostic testing technologies for infectious disease and genetic applications.

NuVasive, Inc. (NASDAQ: NUVA) (the "Company"), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today its intention to offer, subject to market and other conditions, approximately $325 million principal amount of Convertible Senior Notes due 2017 (the "notes") in an underwritten public offering.

Palatin Technologies, Inc. (NYSE Amex : PTN) announced today that the U.S. Patent and Trademark Office issued U.S. Patent No. 7,964,181, titled "Amino Acid Surrogates for Peptidic Constructs."

The Pulse Beverage Corporation (OTCBB: PLSB) ("Pulse" or the "Company"), makers of the PULSEĀ® brand of "good-for-you" NutriPurposeā„¢ beverages, is very pleased to announce the appointment today of Mr. Paddy Sheya as VP and National Sales Manager.

Regenicin, Inc. (OTCBB: RGIN), a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, recently announced it has reimbursed Lonza Walkersville, Inc. for their work in moving Regenicin's leading product candidate through the FDA application process.

SMART Modular Technologies (WWH), Inc. (NASDAQ: SMOD), a leading independent manufacturer of memory modules and solid state storage products, today reported financial results for the third quarter of fiscal 2011 ended May 27, 2011.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it has adjusted its estimate of the range of loss contingency associated with litigation between Palomar Medical Technologies, Inc. (NASDAQ: PMTI) and Syneron's subsidiary, Candela Corporation, from $0 to $50 million as set forth in the notes to its consolidated financial statements as of December 31, 2010, to a range of $0 to $21 million.

World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN), a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today that GNE's algae production facility has successfully grown and harvested Spirulina using the proprietary GB 3000 algae growth system.



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