|FDA Approves Highly Anticipated Weight-loss Pill; NuPathe Stock Rises on NDA Resubmission|
|By Staff and Wire Reports|
|Tuesday, 17 July 2012 18:51|
The Food and Drug Administration is approving a weight loss drug from Vivus Inc. (NASDAQ:VVUS) that many doctors consider the most effective therapy among a new generation of anti-obesity pills.
The agency cleared the pill Qsymia (CUE-simm-ee-ah) for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
Patients taking Qsymia for one year lost 11 percent of their body weight, on average. That was more than two other weight loss pills recently reviewed by the FDA.
Qsymia is the second weight loss drug approved by the FDA in less than a month. In late June the agency approved Arena Pharmaceutical's pill Belviq. Previously the agency had not approved a new drug for long-term weight loss since 1999.
Shares of NuPathe (NASDAQ: PATH) were seeing increased strength during Tuesday's trading session after the company resubmitted its New Drug Application to the U.S. FDA.
NuPathe stated it has resubmitted its New Drug Application (NDA) to the FDA for its migraine patch (NP101). NuPathe expects confirmation from the FDA regarding acceptance, resubmission classification and Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company continues to expect a six-month review by FDA.
"Resubmission of the NDA for our migraine patch is an important milestone for NuPathe," said Jane Hollingsworth, chief executive officer of NuPathe.
"With the additional data and enhancements made to the patch, we have submitted a strong application and have an even more attractive commercial opportunity designed to address the needs of the nearly half of migraine patients who frequently experience both headache pain and migraine-related nausea," she continued.
Tuesday, shares of NuPathe were trading up over 9 percent, at about $4.01 per share.
Mylan Inc. (Nasdaq: MYL) announced it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Somaxon Pharmaceutical, Inc. that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Doxepin Hydrochloride Tablets, 3 mg and 6 mg, which is the generic version of Somaxon's Silenor®, indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
According to the terms of the settlement agreement, Mylan has the exclusive right to sell an authorized generic version of Silenor® in the U.S. and its territories for 180 days beginning on January 1, 2020. In certain limited circumstances, Somaxon's license to Mylan would become effective prior to January 1, 2020. Mylan's right to sell the authorized generic product could extend for as long as 360 days, and after such period Mylan will have the right to sell a generic version of Silenor® under its own ANDA. Pursuant to the agreement, the pending litigation will be dismissed. Additionally, Mylan entered into an agreement to manufacture and supply Silenor® finished product to Somaxon.
EasyMed Services, Inc. (CNSX:EZM)(OTCBB:EMYSF) (MUN:EY6) ("EasyMed" or the "Company") announced today that it has mutually agreed with Biosign Technologies Inc. ("Biosign") to terminate its previously announced transaction to combine operations.
EncounterCare Solutions, Inc. (PINKSHEETS: ECSL) announced today that it has formed a new subsidiary Cyber Fuels, Inc. Cyber Fuel, Inc. will focus on managing new market initiatives in energy for the parent company EncounterCare Solutions, Inc.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), announced today that it has signed a biologics contract manufacturing agreement with its first Brazilian client, RECEPTA Biopharma in Sao Paulo.
Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and manufacturing of oral care and cosmetic dentistry products, reported results for the fourth quarter and for the year ended March 31, 2012 (in US Dollars).
Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded Soligenix a Small Business Innovation Research (SBIR) grant to support further preclinical development of OrbeShield™ (oral beclomethasone 17,21-dipropionate) as a treatment for gastrointestinal acute radiation syndrome (GI ARS).
Unity Management Group (PINKSHEETS: UYMG), a business resource and service company, today announced that its wholly owned subsidiary, On Track Technology (OTT), has acquired Integrated Oil and Gas Technology Solutions (IOG.) IOG is currently a licensed and bonded operator that has met the requirements for the State of Texas to operate oil and gas leases for approximately 2 years now.
VentriPoint Diagnostics Ltd (TSX VENTURE:VPT) (OTCQX:VPTDF) announces the Children's Hospital of Colorado, The Children's Hospital of Philadelphia (CHOP), and The Hospital for Sick Children (SickKids) in Toronto have joined the multi-centre clinical trial studying the most common form of congenital heart disease, Tetralogy of Fallot or Blue-Baby Syndrome.