Teva Announces Exclusive Launch of Generic NIASPAN®; VIVUS Updates European Filing Strategy for Qsiva Print E-mail
By Staff and Wire Reports   
Friday, 20 September 2013 18:30

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 23, 2013.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced the launch of the generic equivalent to NIASPAN® (niacin extended-release) tablets, 500, 750, and 1000mg in the United States.  Teva (TEVA) was first to file, making the product eligible for 180 days of marketing exclusivity.

NIASPAN® is marketed by AbbVie and used with diet to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. NIASPAN® had annual sales of approximately $1.12 billion in the United States, according to IMS data as of June 30, 2013.


announced it has submitted to the European Medicines Agency (EMA) a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial (CVOT) to support the resubmission of the marketing authorization application (MAA) for approval in Europe of Qsiva" for obesity under the centralized procedure. In order to accommodate advice from the European authorities, VIVUS anticipates that patient enrollment for the AQCLAIM study will commence in first quarter 2014.

"Our plan is on track to maximize the value of Qsiva in Europe and we believe that leveraging the AQCLAIM CVOT data is a prudent and scientifically sound approach, guided by our European senior advisors," said Seth Fischer, CEO of VIVUS. "We look forward to working with the European authorities to bring Qsiva to patients suffering from obesity and related comorbidities."

Also Friday:

Advanced Cannabis Solutions, Inc. (OTCQB: CANN) has recently appointed Christopher H. Taylor, CPA, as Chief Financial Officer.

Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced that it has acquired the remaining ownership stake in PocketSonics, Inc., a privately held ultrasound technology firm based in Charlottesville, Virginia.

Arch Therapeutics, Inc. (OTCQB: ARTH)
, today announced it will be featured as a presenting company at the Boulder Peptide Symposium 2013.

Atossa Genetics Inc. (NASDAQ: ATOS)
is proud to announce its sponsorship of The Third Annual Power of Pink luncheon, fashion show and silent auction.

Bioheart (OTCQB: BHRT)
, a leader in developing stem cell therapies to treat cardiovascular diseases, has expanded its team by adding three key strategic positions with regulatory, finance and administrative expertise.

Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS)
is pleased to show its support for First Lady Michelle Obama's new "Drink Up" campaign to get people to drink water and, in response to environmental critics of the new initiative, highlight how the exclusive Alkame™ biodegradable plastic water bottle utilized in all Alkame bottle water products is an ideal choice for both health and environmentally conscience consumers.

Provectus Pharmaceuticals, Inc. (OTCQB:PVCT)
, a development-stage oncology and dermatology biopharmaceutical company reports that BUYINS.NET), a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has issued the following update of its coverage on the Company after releasing the latest short sale data through September 19, 2013.


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