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July 21, 2014
07:03 EDTNVS, ANACAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
News For ANAC;NVS From The Last 14 Days
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November 25, 2015
11:29 EDTNVSStudy says Valeant, others exploding dermatology drug prices, WSJ reports
The JAMA Dermatology journal published a new study that found that retail prices of 19 dermatologic prescription drugs increased fivefold on average between 2009 and 2015, reported The Wall Street Journal. Targretin, marketed by Valeant (VRX), jumped to $30,320 this year from $15,708 last year and $1,687 in 2009, the study found, but "It's not just Valeant," said lead author Miranda Rosenberg. Prices for drugs made by GlaxoSmithKline (GSK) and Novartis (NVS) at least doubled or tripled over the same time frame, the report noted. Reference Link
November 24, 2015
17:51 EDTNVSFDA approves first seasonal influenza vaccine containing an adjuvant
The U.S. FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. Fluad and Agriflu are manufactured by Novartis Vaccines and Diagnostics Limited, an affiliate of Novartis Vaccines and Diagnostics, based in Cambridge, Massachusetts. Reference Link
10:06 EDTNVSHigh option volume stocks
High option volume stocks: BDBD UNXL NVS SEDG BLOX GPRE SIG BPL TIF DY
05:25 EDTNVSNovartis receives EU approval for Entresto
Novartis announced that the European Commission has approved Entresto for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
November 23, 2015
05:37 EDTNVSNovartis receives two EU approvals for Cosentyx
Novartis announced today that the European Commission has approved Cosentyx for the treatment of people living with ankylosing spondylitis, or AS, and psoriatic arthritis, or PsA. For AS, this is the first new treatment advance in 16 years since the development of the current standard of care, anti-tumor necrosis factor, or anti-TNF, therapy. Cosentyx is the first in a new class of medicines called interleukin-17A, or IL-17A, inhibitors to be made available in Europe for AS and PsA. These approvals follow on from the earlier EC approval of Cosentyx for the first-line treatment of patients with moderate-to-severe plaque psoriasis. AS and PsA are common inflammatory joint conditions affecting approximately five million people in Europe, yet they remain significantly under-diagnosed and under-treated. If not treated effectively, they can lead to irreversible damage to the spine and joints, causing life-long pain and disability. New treatments are urgently needed for both conditions as many patients do not respond well to existing treatments, with up to 40% not responding sufficiently to anti-TNFs.
November 20, 2015
17:16 EDTNVSNovartis announces FDA approval of Tafinlar + Mekinist
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14:41 EDTNVSNY AG leads team of states in $390M settlement with Novartis over kickbacks
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14:00 EDTNVSNY AG leads team of states in $390M settlement with Novartis over kickbacks
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10:52 EDTNVSFDA approves new oral medication to treat multiple myeloma
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November 18, 2015
08:11 EDTNVSIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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07:43 EDTNVSJefferies to hold a conference
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November 17, 2015
16:38 EDTNVSAduro Biotech to delay filing 10-Q
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07:34 EDTNVSOphthotech to hold a conference call
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06:08 EDTNVSRoche subsidiary to participate in Ophthotech and Novartis agreement
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05:24 EDTNVSNovartis announces Phase III FLAME head-to-head trial met primary endpoint
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