|January 13, 2014|
|05:34 EDT||CTIC, NVS||Cell Therapeutics to reacquire rights to Pixuvri, Opaxio from Novartis |
Cell Therapeutics (CTIC) announced that it has reached an agreement with Novartis (NVS) to reacquire rights to two anti-cancer compounds Pixuvri and Opaxio. Under the terms of the previous agreement, CTI has been responsible for development and commercialization activities and expenses for both compounds to date. Upon the effective date of termination, CTI will regain all rights that had been granted to Novartis. In exchange for Novartis' agreement to return such rights to CTI, CTI has agreed to make certain potential payments to Novartis based on sales of Opaxio and PIXUVRI and on any sublicense and certain other amounts payable to CTI.
News For CTIC;NVS From The Last 14 Days
Check below for free stories on CTIC;NVS the last two weeks.
|July 24, 2014|
|05:41 EDT||NVS||Novartis announces FDA acceptance of Sandoz application for filgrastim|
Sandoz, a Novartis Group company, announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
|July 23, 2014|
|06:41 EDT||NVS||Array BioPharma shares attractive at current levels, says Piper Jaffray|
Piper Jaffray says shares of Array BioPharma are attractive at current levels ahead of Phase III data readouts for binimetinib in melanoma, selumetinib in Kras-mutant lung, thyroid and uveal melanoma, and filanesib in multiple myeloma. Piper sees the biggest overhang on Array shares as being the financing requirement and it notes that binimetinib could be returned to the company from current partner Novartis (NVS). Nonetheless, it feels investors should take a "serious look" at Array and keeps an Overweight rating on the stock with a $9 price target.
|July 21, 2014|
|07:38 EDT||NVS||Novartis management to meet with JPMorgan|
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
|07:11 EDT||NVS||International Society of DNA Vaccines to hold a conference|
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|07:03 EDT||NVS||Anacor, 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.
|05:12 EDT||CTIC||CTI BioPharma announces approval of Pixuvri in Israel|
CTI BioPharma announced that it has received approval from the Israeli Ministry of Health, or MOH, for Pixuvri. Pixuvri in Israel is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma who have received not more than three previous courses of treatment. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. In Israel, Pixuvri will be distributed and marketed by the Neopharm Group, Israel's second largest pharmaceuticals and health products marketer, once Pixuvri is included in the Israeli National Health Basket of drugs by the MOH. Separately, the Dutch Healthcare Authority, or NZa, and the healthcare insurance board College voor zorgverzekeringen, or CVZ, of the Netherlands have approved funding for Pixuvri as an add-on drug for patients who need a third- or fourth-line treatment option for aggressive B-cell lymphoma. This follows the inclusion of Pixuvri on the HOVON, or Haemato Oncology Foundation for Adults in the Netherlands, treatment guidelines, effective June 1. The inclusion on the Dutch list of reimbursed drugs makes Pixuvri the first registered and reimbursed medicine for the treatment of patients with multiply relapsed or refractory aggressive B-cell NHL in the Netherlands.
|July 17, 2014|
|08:34 EDT||NVS||Vanda requests award of $539M in proceedings with Novartis|
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|05:32 EDT||NVS||Novartis reconfirms FY14 revenue guidance up at low to mid single digit rate|
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
|05:29 EDT||NVS||Novartis reports Q2 Core EPS $1.34, consensus $1.42|
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
|July 15, 2014|
|05:44 EDT||NVS||Novartis to license Google 'smart lens' technology|
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
|05:35 EDT||NVS||Novartis collaborates with Banner Alzheimer's Institute on study|
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
|July 14, 2014|
|07:23 EDT||NVS||Alzheimer's Association to hold a conference|
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|July 10, 2014|
|15:43 EDT||NVS||Novartis siponimod designated as orphan treatment of dermatomyositis|
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