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February 22, 2013
07:25 EDTACT, NVSEMA gives positive recommendation for Actavis' generic imatinib
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imatinib Actavis, 50 mg and 100 mg hard capsule and 100 mg 400 mg Film-coated tablet intended for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia for whom bone marrow transplantation is not considered as the first line of treatment, pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis, or adult patients with Ph+ CML in blast crisis. The applicant for this medicinal product is Actavis Group (ACT). Imatinib Actavis is a generic of Novartis' (NVS) Glivec.
News For ACT;NVS From The Last 14 Days
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June 19, 2013
08:04 EDTACTActavis and Kissei file patent infringement lawsuits against Sandoz and Hetero
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07:51 EDTACTEC fines Ranbaxy, others for blocking cheaper drugs, Economic Times reports
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June 18, 2013
07:22 EDTNVSCitigroup to host a conference
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June 17, 2013
13:20 EDTACTSupreme Court rules generic drug makers can be sued over 'pay to delay'
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11:54 EDTACTSupreme Court ruling a modest negative for generics, says Leerink
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11:49 EDTACTU.S. Supreme Court reverses U.S. Court of Appeals decision in FTC vs. Actavis
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07:28 EDTNVSCambridge Healthtech Institute to host a conference
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07:25 EDTNVS, ACTLeerink to host a conference
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June 16, 2013
14:09 EDTNVSJakafi improved overall survival in Phase III trial of patients with myelofibros
Incyte (INCY) announced results from two ongoing clinical trials of Jakafi, ruxolitinib, an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis, MF, that were presented at the 18th Congress of the European Hematology Associationm EHA, in Stockholm, Sweden. In a three-year follow-up analysis of the Phase III COMFORT-II study, treatment with Jakafi, which is marketed as Jakavi by Novartis (NVS) outside the United States, was associated with improved overall survival and sustained reductions in spleen size compared to best available therapy. In a separate exploratory analysis of bone marrow fibrosis data from an ongoing Phase I/II single-arm, open-label clinical trial, by 48 months of treatment, Jakafi stabilized or reversed fibrosis of the bone marrow in 56 percent and 22 percent, respectively, of patients with MF, a magnitude of an effect not seen historically with best available therapy.
June 12, 2013
07:08 EDTACTDrugstores ready access changes to Plan B pill, WSJ reports
Drugstores (CVS, RAD, WAG) are preparing to change how they stock and sell a widely used emergency contraceptive after the Obama administration agreed to allow the pill to be sold over the counter to customers of all ages. Sold primarily under the brand name Plan B (TEVA, ACT, PRGO), the pill is currently stocked behind pharmacy counters, reports the Wall Street Journal.Reference Link
06:53 EDTACTColumbia Laboratories announces class action lawsuit against company dismissed
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06:05 EDTACTOn the Fly: Periodicals Wrap-Up
WALL STREET JOURNAL: The tectonic plates of the world economy are shifting, moving the yield on the 10-year Treasury to the highest level in more than a year and shaking financial markets. Now, some constants are being questioned in markets, triggering paroxysms in stocks, bonds, commodities and the currencies of emerging markets, the Wall Street Journal reports...Drugstores (CVS, RAD, WAG) are preparing to change how they stock and sell a widely used emergency contraceptive after the Obama administration agreed to allow the pill to be sold over the counter to customers of all ages. Sold primarily under the brand name Plan B (TEVA, ACT, PRGO), the pill is currently stocked behind pharmacy counters, the Wall Street Journal reports...REUTERS: If currency turbulence in emerging markets becomes a full-scale investor flight, the Fed may have a new headache in deciding when to slow its dollar printing policy. The link between U.S. monetary policy and currency runs on the other side of the world could be tighter than many assume, Reuters reports...Toyota Motor (TM) said it’s unlikely to recapture its peak market share it held four years ago in the U.S. (GM, F), its biggest market, the latest sign the carmaker is shifting to improving quality from aggressively expanding sales, Reuters reports...BLOOMBERG: Exchange executives (NYX, NDAQ), long shielded from legal scrutiny in the U.S., have been put on notice that may be changing after federal regulators fined CBOE Holdings (CBOE) $6M for unprecedented lapses in supervision, Bloomberg reports...Borealis Infrastructure Management and its Kuwaiti-British partners abandoned their $8.3B bid for the U.K. water utility Severn Trent (SVTRY) as the offer deadline expired, Bloomberg reports.
June 11, 2013
17:59 EDTACTActavis, Medicines360 announce partnership
Medicines360, a non-profit pharmaceutical company, and Actavis, announced a partnership to support Medicines360’s mission to reduce cost as a barrier to accessing women’s birth control. The Medicines360 and Actavis partnership will make the IUD available in the U.S. commercially and at a very low price in U.S. public sector clinics. As part of this agreement, Actavis has licensed the U.S. commercial rights for the Medicines360 LNG20 Intrauterine Device, or IUD. Medicines360 retains rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women. LNG20, originally developed by Uteron Pharma S.P.R.L. in Belgium, is designed to initially deliver 20 mcg of levonorgestrel per day for the indication of long term contraception, and is currently in Phase III clinical trials in the United States. Pending FDA approval, the LNG20 IUD could be launched in the U.S. as early as 2014.
16:21 EDTNVSOn The Fly: Closing Wrap
Stocks on Wall Street were lower after the Bank of Japan's decision to hold off on any further stimulus measures raised investor concern. The averages recovered much of their early losses in the morning, sitting just below the flat line near noon, but the selling intensified during the second half of the session, with the market trending lower into the close. ECONOMIC EVENTS: In the U.S., NFIB's small business optimism index rose to 94.4 in May from a prior 92.1 reading. Wholesale inventories rose 0.2% in April, matching expectations, and wholesale trade rose 0.5% from the prior month, versus expectations for a 0.1% slide. The Job Openings & Labor Turnover report for April showed openings fell 3% to a seasonally adjusted 3.75M, while hiring jumped nearly 5% to 4.4M. In Asia, the Bank of Japan refrained from changing its policies following recent volatility in its stock and bond markets. The dollar weakened considerably against the Yen, losing more than 2% to trade near the Y96 level. COMPANY NEWS: Sprint (S) shares jumped 17c, or 2.37%, to $7.35 after Japan's Softbank (SFTBF) increased its offer to acquire the telecom company in the face of a potential rival bid from DISH Network (DISH). MAJOR MOVERS: Among notable gainers was Questcor (QCOR), up $5.47, or 14.9%, to $42.18 after the company acquired the right to develop Synacthen from Novartis (NVS). Also higher was Catamaran (CTRX), up $5.33, or 10.95%, to $53.99 after the company struck a ten-year strategic pharmacy benefits agreement with Cigna (CI) and its stock received upgrades from at least three firms. Among noteworthy losers was lululemon (LULU), down $14.43, or 17.54%, to $67.85 after its CEO announced plans to step down and the stock was downgraded at Sterne Agee and UBS. Also lower was GenMark Diagnostics (GNMK) which lost $1.96, or 12.95%, to $13.17, after Natural Molecular Testing launched a cardiac testing panel using technology from GenMark's competitor Luminex (LMNX). INDICES: The Dow was down 116.57, or 0.76%, to 15,122.02; the Nasdaq was down 36.82, or 1.06%, to 3,436.95; and the S&P 500 was down 16.68, or 1.02%, to 1,626.13.
16:07 EDTNVSPDL BioPharma sees Q2 royalty revenue $143M
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12:32 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday but well off their lows after the Bank of Japan held off from implementing any additional stimulus measures. The U.S. market followed Japan's benchmark stock index lower at the open, though the averages climbed back fairly steadily during the morning and stood near session highs just a bit below the flat line near noon. ECONOMIC EVENTS: In the U.S., NFIB's small business optimism index rose to 94.4 in May from a prior 92.1 reading. Wholesale inventories rose 0.2% in April, matching expectations, and wholesale trade rose 0.5% from the prior month, versus expectations for a 0.1% slide. The Job Openings & Labor Turnover report for April showed openings fell 3% to a seasonally adjusted 3.75M, while hiring jumped nearly 5% to 4.4M. In Asia, the Bank of Japan refrained from changing its policies following recent volatility in its stock and bond markets. The benchmark Nikkei fell about 1.5% as the decision disappointed investors who may have expected some action. COMPANY NEWS: Sprint (S) shares rose over 2% after Japan's Softbank (SFTBF) increased its offer to acquire the telecom company in the face of a potential rival bid from DISH Network (DISH). MAJOR MOVERS: Among the notable gainers was Catamaran (CTRX), which was upgraded by at least three Street firms and rose 11% after announcing a ten-year strategic pharmacy benefits deal with Cigna (CI). Also higher were shares of Questcor (QCOR), which jumped 19% after buying the rights to develop Synacthen from Novartis (NVS). Among the noteworthy losers was GenMark Diagnostics (GNMK), which fell 24% after Natural Molecular Testing launched a cardiac testing panel using technology from GenMark's competitor Luminex (LMNX). Also lower were shares of yoga apparel maker lululemon (LULU), which fell 17% after its CEO announced plans to step down and the stock was downgraded at Sterne Agee and UBS. INDICES: Near noon, the Dow was down 6.68, or 0.04%, to 15,231.91; the Nasdaq was down 11.21, or 0.32%, to 3,462.56; and the S&P 500 was down 4.89, or 0.30%, to 1,637.92.
10:14 EDTACTActavis acquires U.S. commercial rights for LNG20 IUD
Medicines360, a non-profit pharmaceutical company, and Actavis announced a partnership to support Medicines360’s mission to reduce cost as a barrier to accessing women’s birth control. The Medicines360 and Actavis partnership will make the IUD available in the U.S. commercially and at a very low price in U.S. public sector clinics. As part of this agreement, Actavis has licensed the U.S. commercial rights for the Medicines360 LNG20 Intrauterine Device. Medicines360 retains rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women. LNG20 is currently in Phase III clinical trials in the United States. Pending U.S. Food and Drug Administration approval, the LNG20 IUD could be launched in the U.S. as early as 2014, the companies said.
09:16 EDTNVSOn The Fly: Pre-market Movers
HIGHER: Dole Food (DOLE), up 21.9% after CEO offers buyout at $12 per share... Questcor (QCOR), up 32% after buying rights to develop Synacthen and Synacthen Depot in the U.S. from Novartis (NVS), upgrade to Buy at CRT Capital... CardioNet (BEAT), up 44% after announcing a three-year national provider agreement with UnitedHealthcare Insurance (UNH)... Catamaran (CTRX), up 13.2% after announcing a ten-year strategic pharmacy benefits deal with Cigna (CI)... Sprint (S), up 2% after Softbank (SFTBF) increases buyout offer terms. Clearwire (CLWR) up 1.2%. LOWER: lululemon (LULU), down 14.9% after reporting earnings, CEO announces plans to step down, stock downgraded at Sterne Agee and UBS... Texas Instruments (TXN), down 2% after narrowing second quarter revenue, earnings forecast ranges... Corinthian Colleges (COCO), down 15.4% after disclosing the receipt of a subpoena from the SEC. Corinthian peer Career Education (CECO) 5.5%... Kinross Gold (KGC), down 5.5% after canceling development project in Ecuador, taking $720M charge, stock downgraded at Canaccord. DOWN AFTER EARNINGS: LDK Solar (LDK), down 8.5%.
07:30 EDTACTActavis added to Analyst Focus List at JPMorgan
JPMorgan added Actavis to its Analyst Focus List citing earnings growth potential following the acquisition of Warner Chilcott. The firm has an Overweight rating on the stock with a $150 price target.
07:02 EDTNVSQuestcor acquires rights to develop Synacthen from Novartis
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