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Stock Market & Financial Investment News

News Breaks
March 21, 2014
13:16 EDTGSK, NVSGlaxo gets injunction against Novartis division over asthma drug, WSJ reports
GlaxoSmithKline (GSK) has obtained a preliminary injunction to prevent Novartis' (NVS) generic-drug division Sandoz from selling its AirFluSal Forspiro inhaler, a rival to Glaxo's Advair inhaler, in Germany due to its purple color, according to the Wall Street Journal. Glaxo is working to hold onto the sales of its $9B Advair treatment, which lost patent protection in most of Europe last year. Reference Link
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July 24, 2014
06:13 EDTGSKGlaxoSmithKline's malaria vaccine candidate accepted for EU regulatory review
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05:41 EDTNVSNovartis 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
09:33 EDTGSKGlaxoSmithKline reports record Promacta/Revolade Q2 revenue of $92M
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09:17 EDTGSKOn The Fly: Pre-market Movers
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07:19 EDTGSKGenmab reports Q2 Arzerra net sales GBP 12.8M
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07:12 EDTGSKGlaxoSmithKline lowers 2014 core EPS outlook to 'similar' to 2013
GSK now expects 2014 core EPS to be "broadly similar" to 2013 versus previous expectations of 4%-8% growth. It added, "Given impact of recent sustained strength of Sterling on free cash flow, share repurchases over balance of 2014 likely to be immaterial."
07:09 EDTGSKGlaxoSmithKline reports Q2 core EPS down 12% to 19.1p
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07:09 EDTGSKMylan wins restraining order against Apotex for generic version of GSK's Paxil
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06:41 EDTNVSArray 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 22, 2014
09:55 EDTGSKLupin, private equity funds weigh bids for GSK's older drugs, Reuters reports
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July 21, 2014
07:38 EDTNVSNovartis 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 EDTGSK, NVSInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, 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.
July 17, 2014
08:34 EDTNVSVanda requests award of $539M in proceedings with Novartis
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07:18 EDTGSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
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06:23 EDTGSKGlaxoSmithKline admits to bribing Chinese officials in 2001, FT reports
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05:32 EDTNVSNovartis 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 EDTNVSNovartis 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 16, 2014
07:14 EDTGSKIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
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