Impax Laboratories Inc. (IPXL: Quote) on Monday announced that FDA has issued a complete response letter for its RYTARY NDA for the treatment of idiopathic Parkinson's disease. The FDA has sought a satisfactory re-inspection of the company's Hayward facility before RYTARY could be approved. The Hayward facility is involved in the development of RYTARY, and supportive manufacturing and distribution activities.
Cordis Corp., a Johnson & Johnson (JNJ: Quote) company, on Monday presented two-year data from a pivotal study, dubbed STROLL, which assessed the safety and efficacy of S.M.A.R.T. vascular stent systems in the superficial femoral artery.
According to the company, the exceptional trial results highlight not only the durability of the clinical outcomes such as patency and target lesion revascularization using the S.M.A.R.T. Stent in the femoro-popliteal vessels, but also the associated patient outcomes.
Allergan Inc.'s (AGN: Quote) BOTOX on Friday was granted FDA approval for yet another indication namely, for overactive bladder for adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Since hitting the cosmetic market in 2002, Botox has been approved for a variety of medical applications, and overactive bladder marks the 26th indication for which Botox is approved.
The full year 2012 BOTOX product net sales are expected to range between $1.76 billion to $1.80 billion.
Solazyme Inc. (SZYM: Quote) on Friday priced the offering of $115 million of 6.00% convertible senior subordinated notes. Net proceeds from this offering are expected to be about $109.8 million. The sale of the Convertible Notes is expected to close on January 24, 2013, subject to customary closing conditions.
Guided Therapeutics Inc. (GTHP: Quote) will be showcasing its LuViva Advanced Cervical Scan at the 38th Annual Arab Health 2013 Healthcare Exhibition and Congress taking place January 28 - 31, 2013 in Dubai, United Arab Emirates.
LuViva currently has marketing approval from Health Canada and received its first CE Mark, an ISO 60601 Edition 2 Notification, in July. The device has been under FDA Premarket review since September 23, 2010. An amended PMA application was filed with the U.S. regulatory agency in November 2012.
Trius Therapeutics Inc. (TSRX: Quote) on Friday fell over 6% following the pricing of an underwritten public offering of 6.3 million shares of its common stock at $4.75 each. The offering is expected to close on or about January 24, 2013, subject to customary closing conditions.
The company expects to report topline results from a pivotal phase III trial of Tedizolid, dubbed ESTABLISH 2, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in early 2013.
Pfizer Inc.'s (PFE: Quote) Bosutinib on Friday received positive opinion for conditional marketing authorization from the Committee for Medicinal Products for Human Use for the treatment of Ph+ chronic myelogenous leukemia with resistance or intolerance to prior therapy in Europe.
The positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the EU. Pfizer anticipates a decision from the Commission in the coming months.
Sirona Biochem Corp. (SBM.V: Quote) has begun trading on OTCQX International beginning Friday. OTCQX International is a segment of the OTCQX marketplace reserved for high-quality non-U.S. companies listed on a qualified stock exchange in their home country.
by RTT Staff Writer
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