China-Biotics Inc. Receives NASDAQ Delisting Notification. Shire Announces FDA Approval For FIRAZYR. Print
By Staff and Wire Reports   
Thursday, 23 June 2011 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 23, 2011.

China-Biotics Inc. (NASDAQ:CHBT), announced the Company received a letter from the NASDAQ Listing Qualification staff asserting that, because the Company has not yet filed its Annual Report on Form 10-K for the fiscal year ended March 31, 2011, and based upon disclosures made by the Company in its recently filed Form 12b-25 and additional information provided to NASDAQ, the Company no longer complies with the NASDAQ Listing Rules for continued listing.

In addition, the NASDAQ Letter requested that the Company provide to NASDAQ a formal plan of compliance setting forth the steps that the Company proposes to take to regain compliance for continued listing of the Company's common stock on the NASDAQ, as well as certain other information relevant to NASDAQ's evaluation of the plan of compliance. NASDAQ has established an expedited schedule for the Company to submit its plan of compliance and related information.

The Company's response is due no later than July 5, 2011. The Company will use its best efforts to submit a plan of compliance to NASDAQ, together with the other information requested, on or before July 5, 2011. There can be no assurance that the Company will be able to meet this deadline or that the Company's plan of compliance and other related information will sufficiently satisfy NASDAQ to avoid delisting.

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Shire plc (NASDAQ:SHPGY) announced the Pulmonary-Allergy Drugs Advisory Committee to the FDA recommended, by a vote of twelve to one, that the efficacy and safety data provides substantial evidence to support approval of FIRAZYR (icatibant) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years and older.

In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients. The Committee's input will be considered by the FDA in its review of the New Drug Application for FIRAZYR.

The Company has been assigned an action date of August 25, 2011 under the Prescription Drug User Fee Act. In considering whether FIRAZYR is safe and effective, the Committee considered data from three double-blind, randomized, controlled phase III trials, known as the FAST-1, FAST-2, and FAST-3 studies.

The results from these trials, which included patients with cutaneous, abdominal, and laryngeal attacks, provided substantial and convincing evidence of clinically meaningful benefit of FIRAZYR for the treatment of acute HAE attacks in adults. Treatment of acute attacks with 30 mg of FIRAZYR administered under the skin was generally well tolerated with a consistent safety profile across all clinical studies.


Also Thursday:


BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has entered into a definitive agreement to acquire a bulk biologics manufacturing plant from Pfizer, located in Shanbally, Cork, Ireland.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) ("Connectyx"), manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (ePHM) for maintaining personal health records (PHR), announced today that it will participating as a preferred vendor in Texas EYEPA meeting s to be held in five Texas cities from June 27th through July 1st .

Endo Pharmaceuticals (Nasdaq:ENDP) announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted.

FluoroPharma Medical (OTC.BB: FPMI) announced it has received subscriptions from select accredited investors for gross proceeds of $1.6 million in a private placement offering.

GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today the opening of a third site for testing the therapeutic potential of its HIV/AIDS vaccine.

Luminex Corporation (NASDAQ:LMNX) has won two American Business Awards - Stevie Awards - Most Innovative Company of the Year (for companies with less than 2,500 employees) and Business Innovation of the Year for the MAGPIX System.

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company's proprietary Vesicular Monoamine Transporter 2 inhibitor (VMAT2), NBI-98854.

Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that it has completed its previously announced private placement of units of its securities consisting of an aggregate of 5,000,000 shares of common stock and five-year warrants to purchase an additional 2,500,000 shares of common stock for aggregate gross proceeds of $2.5 million.

Phototron Holdings, Inc. (OTCBB: PHOT) (OTCQB: PHOT), the designer, manufacturer and seller of the PHOTOTRON Hydroponic Indoor Grow System, today announced that it will unveil its new Phototron product line at the 2011 Medical Cannabis Cup San Francisco, June 25 and 26 at the Concourse Exhibition Center sponsored by High Times Magazine.

Radient Pharmaceuticals Corporation (NYSE Amex: RPC) (OTCQX: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced that its common stock will cease trading on the NYSE Amex and transition to the OTCQX® effective with the open of business on Thursday, June 23, 2011.

SeraCare Life Sciences, Inc. (NASDAQ:SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today acknowledged the receipt of an unsolicited offer from MSMB Capital proposing to purchase all of the outstanding shares of SeraCare for $4.25 per share.



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