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News For NVS;MOS;SCCO;ADM;IP From The Last 14 Days
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March 6, 2015
11:43 EDTNVSHospira comments on FDA approval of first biosimilar in the U.S.
Hospira (HSP) said in a statement that it "applauds Sandoz (NVS) and the U.S. FDA on today's FDA approval of the first biosimilar in the United States. This is a watershed moment for improving patient access to safe, effective and more affordable biologic medicines. As a global provider of biosimilars, Hospira has seen first-hand the positive impact of biosimilars in other countries, and we are a proud participant in these early stages of the development of a pathway for these medicines in the United States." "Biosimilars represent a transformational opportunity to improve patient access and provide much-needed financial relief to the U.S. healthcare system," said Sumant Ramachandra, M.D., Ph.D., senior VP, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "This approval is good news for the entire healthcare system and brings us one step closer to making these important medications available for the patients who need them. With two biosimilar applications currently under review by the U.S. FDA, Hospira is committed to bringing more affordable biologic medicines to patients in the United States. We look forward to continuing to partner with the FDA on the approval pathway for our biosimilars, so that more and more patients and healthcare providers have access to the benefits of biosimilars."
09:14 EDTNVSFDA approves first biosimilar Zarxio from Sandoz
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09:11 EDTNVSFDA approves Novartis biosimilar of Amgen's Neupogen
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March 5, 2015
10:49 EDTNVSArrowhead strengthened position in RNAi with Novartis deal, says Piper Jaffray
After Arrowhead Research (ARWR) purchased Novartis’ (NVS) RNAi R&D portfolio and associated assets for $35M in cash and stock, Piper Jaffray said it believes the deal further consolidates and strengthens Arrowhead's position in the RNAi space. The firm maintains its $12 price target and Overweight rating on Arrowhead shares.
09:16 EDTNVSPlasmaTech begins enrollment of breast cancer trial with Novartis' Afinitor
PlasmaTech (PTBI) has begun enrollment in a clinical trial evaluating MuGard in the prevention and treatment of stomatitis in breast cancer patients using everolimus, marketed by Novartis (NVS) Oncology under the tradename Afinitor.
08:01 EDTNVSArrowhead to host conference call
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07:49 EDTNVSOmnicare SCG ACS to provide services for Novartis Farydak
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07:31 EDTNVSArrowhead acquires Novartis' RNAi research and development portfolio
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March 4, 2015
11:09 EDTNVSSanofi, Novartis, Shire may be weighing Genfit acquisition, Bloomberg says
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07:53 EDTNVSDiplomat Pharmacy to dispense Novartis Psoriasis drug Cosentyx
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March 3, 2015
11:46 EDTNVSLeerink biotech analyst holds an analyst/industry conference call
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March 2, 2015
08:07 EDTNVSArray BioPharma announces completion of binimetinib and encorafenib transactions
Array BioPharma (ARRY) announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85M from Novartis (NVS). Effective March 2, 2015, Novartis' global, exclusive license to binimetinib terminated with all rights reverting to Array, and Array received global rights to encorafenib. Array will receive an $85M upfront payment from Novartis and reimbursement for certain transaction-related expenses. Novartis will provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array patent and other intellectual property rights it owns to the extent they relate to binimetinib and encorafenib. Other than a de minimis payment to Novartis from Array, there are no milestone payments or royalties payable between the parties under the encorafenib agreement. As part of the transactions, 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. Array entered into a third party agreement necessary to complete the transactions. Net consideration Array agreed to pay amounts to $25M. This payment is consistent with the earnings guidance provided on the quarterly conference call held on February 3, 2015. Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials for binimetinib (other than COLUMBUS, as described above), Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs required to complete these studies. Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array's designation. Novartis also retains binimetinib and encorafenib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib and 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 and binimetinib.
07:31 EDTNVSIncyte appoints Steven Stein as Chief Medical Officer
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07:25 EDTIPPackaging sector downgraded to Market Weight at Wells Fargo
Wells Fargo downgraded the Packaging sector to Market Weight from Overweight saying current valuation levels reflect known catalysts. Wells made no stock rating changes along with the sector, and continues to view International Paper (IP) and Crown Holdings (CCK) as its top picks. Other Outperform ratings in the space include Berry Plastics (BERY), Greif (GEF), Owens-Illinois (OI) and Packaging Corp. (PKG).
February 27, 2015
12:19 EDTIPInternational Paper files automatic mixed securities shelf
11:33 EDTNVSNovartis says phase II data highlights benefits of Alcon RTH258 in wet AMD
Novartis reports Alcon presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular age-related macular degeneration, or wet AMD. The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity, from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness as measured by spectral domain optical coherence tomography. Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
07:50 EDTNVSNovartis holders approve dividend increase to CHF 2.60
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07:25 EDTNVSNovartis lung cancer drug Zykadia recommended for EU approval
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07:16 EDTNVSZykadia recommended by EMA for approval in advanced NSCLC
The European Medicines Agency has recommended granting a conditional marketing authorization for Zykadia. Zykadia is recommended for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase positive non-small cell lung cancer, or NSCLC, when the disease is advanced and has already been treated with crizotinib. The applicant for Zykadia is Novartis Europharm.
February 26, 2015
09:05 EDTNVSFDA grants Sandoz tentative approval of Fusilev generic
The FDA posted on its website that it granted Novartis's Sandoz tentative approval for levoleucovorin calcium, a generic of Spectrum's (SPPI) colon cancer drug Fusilev. Reference Link
February 25, 2015
14:10 EDTNVSPharmacyclics downgraded to Hold on lack of upside at Deutsche Bank
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12:54 EDTNVSPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTNVSPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
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12:13 EDTNVSGlaxoSmithKline sees Novartis transaction closing next week
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08:07 EDTNVSNovartis' Farydak myeloma drug approved by FDA, to be distributed by Diplomat
Novartis' (NVS) drug Farydak for the treatment of patients with multiple myeloma Diplomat Pharmacy has been approved by the FDA. The drug is now a treatment option for patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Farydak will be distributed by Diplomat Pharmacy (DPLO).
February 24, 2015
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
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10:00 EDTIPOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AMC Networks (AMCX) downgraded to Neutral from Outperform at Macquarie... American Airlines (AAL) downgraded to Market Perform at Cowen... Armstrong World (AWI) downgraded to Hold from Buy at KeyBanc... Basic Energy (BAS) downgraded to Outperform from Strong Buy at Raymond James... CSC (CSC) downgraded at Stifel... Chevron (CVX) downgraded to Perform from Outperform at Oppenheimer... Choice Hotels (CHH) downgraded to Underweight from Equal Weight at Barclays... Eni SpA (E) downgraded to Underperform from Hold at Jefferies... Fifth Street Asset (FSAM) downgraded to Neutral from Outperform at Credit Suisse... HSBC (HSBC) downgraded to Neutral from Buy at UBS... Home Loan Servicing (HLSS) downgraded to Neutral from Overweight at Piper Jaffray... Huntington Ingalls (HII) downgraded to Underperform from Neutral at Credit Suisse... International Paper (IP) downgraded to Hold from Buy at Deutsche Bank... Kayne Anderson (KED) downgraded at Stifel... Landstar System (LSTR) downgraded to Hold from Buy at Deutsche Bank... Multi-Color (LABL) downgraded to Neutral from Long-Term Buy at Hilliard Lyons... Newmont Mining (NEM) downgraded to Neutral from Overweight at HSBC... ONEOK Partners (OKS) downgraded to Underweight from Neutral at JPMorgan... ONEOK (OKE) downgraded to Underweight from Neutral at JPMorgan... Olympic Steel (ZEUS) downgraded to Underperform from Neutral at Credit Suisse... Polypore (PPO) downgraded to Market Perform from Outperform at William Blair... Rosetta Resources (ROSE) downgraded to Equal Weight from Overweight at Stephens... Salix (SLXP) downgraded to Neutral from Buy at UBS... Sprint (S) downgraded to Sell from Neutral at BTIG... St. Jude Medical (STJ) downgraded to Underperform from Outperform at Credit Suisse... Timmins Gold (TGD) downgraded on lack of near-term production catalysts at RBC Capital... Transocean Partners (RIGP) downgraded to Underweight from Equal Weight at Barclays... Vodafone (VOD) downgraded to Underperform from Neutral at BofA/Merrill... Williams Partners (WPZ) downgraded to Neutral from Buy at Citigroup... Williams (WMB) downgraded to Neutral from Buy at Citigroup... Worthington (WOR) downgraded to Neutral from Outperform at Credit Suisse... Zillow Group (Z) downgraded at Macquarie.
07:45 EDTIPInternational Paper downgraded to Hold from Buy at Deutsche Bank
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February 23, 2015
15:00 EDTNVSFDA approves Farydak for treatment of multiple myeloma
The FDA approved Farydak for the treatment of patients with multiple myeloma, a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. Farydak is marketed by Novartis.
13:40 EDTNVSAnalysts clash on Spectrum outlook after patent suit setback
Two research firms had divergent views on Spectrum Pharmaceuticals (SPPI) after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. BACKGROUND: Late Friday, a federal judge ruled that Novartis' (NVS) levoleucovorin, a generic version of Spectrum's Fusilev, does not infringe on Spectrum's intellectual property. Fusilev is indicated after high-dose methotrexate therapy in osteosarcoma, a type of cancer that starts in the bones. It is also used to treat patients with advanced metastatic colorectal cancer. BEARISH TAKE: Roth Capital analyst Joseph Pantginis downgraded Spectrum to Neutral from Buy following the ruling, as he believes the risk to the company's revenue has risen. The company is meaningfully less likely to become profitable again, wrote Pantginis, noting that Fusilev accounted for about 50% of the company's product revenue. According to the analyst, Spectrum is becoming increasingly focused on developing its earlier stage drugs, and he expects those drugs to grow slowly. Pantginis slashed his price target on the shares to $7 from $15. BULLISH TAKE: In a note to investors earlier today, Reni Benjamin, an analyst at research firm H.C. Wainwright, wrote that the stock's plunge after the judge's ruling "creates a table-pounding buying opportunity," noting that Fusilev has been granted exclusivity as a colorectal treatment until 2018. Benjamin does not expect the company's revenue from Fusilev to decline at all until 2018, as a citizen's petition submitted by Spectrum to the FDA, along with an appeal the company is mounting to Friday's ruling, and the difficulty that Novartis will have launching its version of the drug while the appeal is ongoing, will help prevent Spectrum's revenue from dropping. Also likely to protect Spectrum's revenue are the strong relationships that the company has developed with hospitals and community doctors, the analyst stated. He kept a $15 price target and Buy rating on the shares. PRICE ACTION: In mid-afternoon trading, Spectrum tumbled $1.44, or 19.3% to $6.02.
12:21 EDTNVSOn The Fly: Midday Wrap
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11:29 EDTADMEU investigates Cargill's proposed acquisition of ADM's chocolate business
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11:17 EDTNVSFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
07:49 EDTIPFebruary fall in paper prices a modest negative, says Jefferies
Jefferies notes that according to PPW, unbleached kraft paperboard and solid unbleached sulfate prices fell modestly in February due to weak frozen food and beverage demand. The firm views the drop in SBS prices as a modest negative for RockTenn (RKT)/MeadWestvaco (MWV), Graphic Packaging (GPK) and International Paper (IP). It feels the impact should be limited, however, given the lag on the pass throughs in the converting business.
07:40 EDTMOSBMO Capital to hold a conference
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07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
February 20, 2015
07:08 EDTNVSAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
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