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News Breaks
April 22, 2014
07:46 EDTNVS, GSKGlaxo thinks Novartis agreement could mean future disposals, Reuters says
GlaxoSmithKline (GSK) said the company's agreement with Novartis (NVS) narrowed its focus on the major areas of vaccines, respiratory, consumer and HIV drugs, and might lead to the disposal of its portfolio of older medications, according to Reuters, citing comments from GlaxoSmithKline CEO Andrew Witty. Reference Link
News For GSK;NVS From The Last 14 Days
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January 27, 2015
05:25 EDTNVSNovartis reports Q4 core EPS $1.21, consensus $1.21
Reports Q4 revenue $14.63B, consensus $14.58B. Reports Q4 pharmaceuticals net sales $7.9B.
January 26, 2015
09:19 EDTGSKGlaxoSmithKline announces availability of two new products for asthma
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07:34 EDTNVSArray BioPharma acquisition viewed positively at Leerink
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January 23, 2015
18:37 EDTNVSNovartis confirms FDA approval of Bexsero
Novartis announced that the US FDA has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.
16:21 EDTNVSFDA approves Novartis vaccine Bexsero
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12:33 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street were mixed at midday, with the Nasdaq leading and the Dow lagging. The futures dipped this morning after UPS (UPS) pre-announced that its quarterly earnings would miss Street estimates. The earnings miss dragged other transportation names lower. ECONOMIC EVENTS: In the U.S., Markit's preliminary January manufacturing PMI fell to 53.7 from 53.9 previously, versus expectations for a reading of 54.0. Existing home sales rebounded 2.4% to a 5.04M rate in December, which was below the consensus forecast for a 3% increase. The leading indicators rose 0.5% to 121.1 in December, topping expectations for a rise of 0.4%. COMPANY NEWS: Shares of UPS plunged over 9% after the shipping giant warned that its Q4 adjusted EPS is now expected to be $1.25, below the consensus forecast of $1.47. "UPS invested heavily to ensure we would provide excellent service during peak when deliveries more than double. Though customers enjoyed high quality service, it came at a cost to UPS. Going forward, we will reduce operating costs and implement new pricing strategies during peak season,” said CEO David Abney. Subsequently, its peer, FedEx (FDX), reaffirmed its FY15 EPS forecast of $8.50-$9.00. The outlook compares to a consensus forecast of $8.97. FedEx shares, which were briefly halted for the announcement, are down 2% afterward... Shares of McDonald’s (MCD) slid about 1% near noon after its earnings miss, though the world’s largest restaurant chain's same-store sales declined less than analysts expected. Same-store sales in the company's fiscal fourth quarter declined 0.9%, versus the Consensus Metrix analysts' estimate for a 1.5% drop. Of note, McDonald’s U.S. same-store sales had their first monthly gain in more than a year in December, having risen 0.4%. MAJOR MOVERS: Among the notable gainers was Starbucks (SBUX), which rose 6.5% and had several research firms issue upbeat notes after the company reported in-line results last night. At least three firms responded to the report by raising their price targets on the shares. Also higher was Array BioPharma (ARRY), which jumped 38% after announcing that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. Among the noteworthy losers was Avon Products (AVP), which dropped 11% after Wells Fargo downgraded the stock to Market Perform from Outperform after shares rallied yesterday over 14% following a report that the company has held talks with TPG Capital about a possible deal. Wells says it leveraged buyout math suggests a takeout of the entire company is unlikely. Also lower was DreamWorks Animation (DWA), which fell 9% after announcing a new strategic plan that will see it cut its feature production from three films per year down to two and cut about 500 jobs. INDEXES: Near midday, the Dow was down 42.58, or 0.24%, to 17,771.40, the Nasdaq was up 9.68, or 0.2%, to 4,760.08, and the S&P 500 was down 3.40, or 0.16%, to 2,059.75.
08:52 EDTNVS, GSKArray BioPharma to hold a conference call
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08:10 EDTNVS, GSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
07:36 EDTNVSIncyte earns $25M milestone payment from Novartis for Jakavi
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07:25 EDTNVSNovartis drug Jakavi recommended by CHMP for EU approval
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06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 21, 2015
12:35 EDTNVSNovartis confirms FDA approval for Cosentyx
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12:33 EDTNVSFDA approves Novartis psoriasis drug Cosentyx
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12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:26 EDTNVSHigh option volume stocks
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January 16, 2015
08:31 EDTNVS, GSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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January 14, 2015
11:45 EDTNVSImmunoGen discloses triggering of $5M milestone payment from Novartis
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