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Pharmaceutical industry

Biotech and Pharmaceutical Sector Update: FDA Clearances, Earnings, and Expansion

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) granted clearance to Vasomedical's Combined ECG Holter and Ambulatory Blood Pressure Monitoring System, while Cell Therapeutics received a Complete Response Letter for its Pixuvri NDA. Meanwhile, Ardea Biosciences completed a public offering of common stock, raising approximately $77.1 million, and NexMed expanded its Bio-Quant subsidiary facilities in San Diego.

Key Takeaways:

  • Vasomedical received FDA 510(k) clearance for its Combined ECG Holter and Ambulatory Blood Pressure Monitoring System, expanding its product offerings in the non-invasive treatment and management of cardiovascular diseases.
  • Cell Therapeutics received a Complete Response Letter from the FDA for Pixuvri NDA, citing concerns about the product's safety and effectiveness, and has decided to pursue an expanded access program while conducting an additional study in aggressive non-Hodgkin's lymphoma.
  • Ardea Biosciences completed a public offering of 4,025,000 shares of common stock, raising approximately $77.1 million, to be used for research and development purposes.
  • NexMed expanded its San Diego facilities to accommodate an increase in demand for its pre-clinical research services, demonstrating the company's growth and diversification of its service capabilities.
  • Bio-Quant, a subsidiary of NexMed, has approximately 28,000 sq. ft of modern, state-of-the-art laboratory, vivarium, and office space.
  • TimelessWealth.net, a trading and investing community, provides investors with high-yielding returns and real-time trading ideas, with a focus on creating high net-worth individuals through intelligent investments.

Statistics:

  • $77.1 million: the net proceeds to Ardea Biosciences from the sale of shares in the public offering.
  • 28,000 sq. ft.: the size of the Bio-Quant facilities in San Diego, which accommodate laboratory, vivarium, and office space.
  • 20%: the increase in revenues of Bio-Quant in 2009, reflecting the company's growth and diversification of its service capabilities.
  • 04-08-2010: the date of the latest Comtex SmarTrend Alert, which indicated an UPTREND on 11-25-2009 for RDEA @ $14.65.

Sources:

  • Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System. WESTBURY, N.Y., Apr 09, 2010.
  • Cell Therapeutics, Inc. Receives Complete Response Letter from the FDA for Pixantrone NDA. SEATTLE, April 9, 2010.
  • Ardea Biosciences, Inc. Announces Completion of Public Offering of Common Stock. SAN DIEGO, April 9, 2010.
  • NexMed Announces Expansion of Its Bio-Quant Subsidiary Facilities. SAN DIEGO, Apr 09, 2010.
  • About TimelessWealth.net.

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