FDA Approves Zubsolv; CorMedix Shares Volatile Following News of CE Mark for Neutrolin Print E-mail
By Staff and Wire Reports   
Friday, 05 July 2013 18:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 5, 2013.

Orexo U.S (OTC: ORXOF)
announced it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII). Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and…Orexo U.S (OTC: ORXOF) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII). Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with higher bioavailability, a fast dissolve time, smaller tablet size and a new menthol flavor.

Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.i,ii,iii Although it is a treatable condition, about 60 percent of opioid dependent patients in the U.S. do not receive treatment.iii Every year thousands of patients continue to misuse opioids rather than risk public exposure by receiving treatment.iv

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CorMedix Inc. (NYSE: CRMD)
announced it has received CE Mark approval for Neutrolin®, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial (antibacterial and antifungal) combination that is active against common microbes including antibiotic-resistant strains, and in addition, inhibits the formation of biofilm. Neutrolin, as a catheter lock solution, has been proven to significantly reduce the incidence of catheter related bloodstream infections (CRBIs) as well as maintain catheter patency by inhibiting thrombosis, thus reducing the need for systemic antibiotics and prolonging central venous catheter life.

CorMedix received the CE Mark for Neutrolin as a Class III device, which allows the company the ability to market and sell the catheter lock solution in European Union (EU) member countries that have adopted the Medical Devices Directive (MDD) without being subject to additional national regulations with regard to demonstration of performance and safety (although certain EU member countries may request or require additional performance and/or safety data on a case-by-case basis). The CE mark also permits the sale of Neutrolin in countries that have an MDD Mutual Recognition Agreement with the EU.



Also Friday:



Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating and often fatal rare diseases, today announced that on July 1, 2013, Aegerion granted stock options to purchase an aggregate of 19,700 shares of common stock to five new employees under the inducement stock option program described below.

Baxter International Inc. (NYSE: BAX)
today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

Biogen Idec (NASDAQ: BIIB)
and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) presented new data that support the clinical and safety profile of their long-lasting recombinant factor VIII candidate ELOCTATE* for hemophilia A.

CorMedix Inc. (NYSE MKT: CRMD)
today announced that it has received CE Mark approval for Neutrolin®, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.

PerkinElmer, Inc., (NYSE:PKI)
a global leader focused on improving the health and safety of people and the environment, today announced that on Thursday, August 1, 2013, after market close, the Company will release second quarter 2013 results.

Theragenics Corporation® (NYSE: TGX)
, a medical device company serving the surgical products and prostate cancer treatment markets, today announced it has signed a Supply and Reseller agreement with Accelyon Limited.

First Manhattan Co. (“FMC”), an owner-managed and operated investment advisory firm and the owner of approximately 9.9 percent of the outstanding shares of VIVUS, Inc. (NASDAQ: VVUS), today announced that two leading proxy advisory firms, Institutional Shareholder Services Inc. ("ISS") and Egan Jones Proxy Services (“Egan Jones”) have recommended that Vivus stockholders vote for the election of FMC director nominees to the Vivus board of directors.

VIVUS, Inc. (Nasdaq:VVUS)
, a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today issued the following statement in response to reports by Institutional Shareholder Services (ISS) and Glass Lewis & Co. (Glass Lewis) regarding VIVUS's 2013 Annual Meeting of Stockholders to be held on July 15, 2013.



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