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Stock Market & Financial Investment News

News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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October 20, 2014
18:51 EDTACTOn The Fly: After Hours Movers
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18:27 EDTACTActavis among bidders for Omega Pharma, reports Bloomberg
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15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
12:36 EDTJNJOptions with decreasing implied volatility
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09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
08:14 EDTJNJPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
07:19 EDTGSK, BMYIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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06:28 EDTTEVA, ACTAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
16:55 EDTJNJStocks end volatile week lower amid oil price plunge
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16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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14:50 EDTGSK, NVSBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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09:47 EDTACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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October 16, 2014
17:27 EDTACTNoven files patent infringement suit against Actavis
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15:10 EDTACTAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFE, ACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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09:57 EDTBMY, JNJLeerink biotech analysts hold an analyst/industry conference call
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09:38 EDTJNJActive equity options trading on open
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09:15 EDTJNJJ&J comments positive for Anika Therapeutics, says Summer Street
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07:37 EDTJNJJohnson & Johnson pullback a buying opportunity, says Leerink
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07:34 EDTJNJJohnson & Johnson reported strong Q3 results, says Argus
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07:14 EDTJNJJohnson & Johnson price target lowered to $110-$111 from $119-$120 at Wells Fargo
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October 14, 2014
16:22 EDTJNJOn The Fly: Closing Wrap
The Wall Street averages were mixed after three of the U.S.'s largest banks reported on their quarterly results and Germany slashed its economic forecasts for this year and next. Following the mostly solid earnings reports from the banks and Dow member Johnson & Johnson (JNJ) investors appeared to breathe a sigh of relief and sent the averages higher in early trading. With oil prices falling almost 5% and settling at a recent low, the averages pared their gains and struggled in positive ground. Another late day slide ended with the averages mixed, as the Nasdaq led and the Dow lagged. ECONOMIC EVENTS: In the U.S., the International Energy Agency said in its monthly oil market report that world oil demand growth would be weaker than previously expected. Afterward, WTI crude oil futures fell 4.6% at $81.84, marking their biggest percentage drop since late 2012 and the lowest settlement for the benchmark in over two years. The National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. In Europe, Germany's government cut its forecasts for gross domestic product growth to 1.2% in 2014 and 1.3% next year from its prior view of 1.8% growth this year and 2% in 2015. COMPANY NEWS: The first of America's big banks issued their quarterly reports, with JPMorgan's (JPM) headline earnings per share coming in below analysts’ consensus estimate, Wells Fargo (WFC) reporting in-line earnings and improved credit quality and Citigroup (C) posting better than expected adjusted third quarter profit. Citi, which also announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit after an investigation uncovered illegal conduct, saw its stock fare the best among the three, rising $1.57, or 3.15%, to $51.47... Another Dow member, Johnson & Johnson, reported better than expected profits and revenues and raised its FY14 EPS outlook, but its stock slid $2.11, or 2.13%, to $97.01. MAJOR MOVERS: Among the notable gainers was Domino's Pizza (DPZ), which rose $8.58, or 11.33%, to $84.30 after the pizza chain owner and franchisor reported better than expected third quarter earnings per share and revenue. Also higher was Skyworks (SWKS), which advanced $3.59, or 7.92%, to $48.91 after the supplier of chips to Apple (AAPL) raised its fourth quarter earnings per share outlook and revenue guidance. Among the noteworthy losers was Exactech (EXAC), which dropped $4.09, or 16.63%, to $20.50 after the company warned its Q3 income and revenue will likely miss its prior guidance. Also lower were shares of Gilead (GILD), which fell $4.26, or 4.2%, to $97.18 amid a number of developments. Competitor Johnson & Johnson said it would seek to make its own hepatitis C treatment accessible and "competitive," which some may have read as an indication of a potential price cut, and Ireland said it plans to close its "Irish Double" tax loophole, which currently benefits Gilead. INDEXES: The Dow slipped 5.88, or 0.04%, to 16,315.19, the Nasdaq rose 13.52, or 0.32%, to 4,227.17, and the S&P 500 added 2.96, or 0.16%, to 1,877.70.
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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12:41 EDTJNJGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
12:33 EDTJNJZimmer, Stryker have postive read-through from J&J, says Wells Fargo
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12:20 EDTJNJOn The Fly: Midday Wrap
Stocks on Wall Street were higher at midday after three of the nation's largest banks reported on their results in the most recent quarter of the year. The market began the session in positive territory but the move seemed tenuous and the averages were almost back in negative ground within a half hour of the opening bell. As the morning progressed and the bears were unable to gain control, the buyers emerged and pushed the Dow to a triple digit gain and the Nasdaq to an increase of nearly 1.5%. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. COMPANY NEWS: JPMorgan (JPM) swung to a third quarter profit, but its headline earnings per share fell below analysts’ consensus estimate. Of note, the company's press release on its results came out earlier than planned on Nasdaq's (NDAQ) Shareholder.com website, which the exchange operator attributed to an internal "human error." Wells Fargo (WFC) reported in-line earnings and stronger credit quality, but its stock slid 1.4% following the report. Citigroup (C) generated the most headlines, however, as it reported better than expected adjusted third quarter profit, announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit that provided personal security services after an investigation uncovered illegal conduct. Shares of Citi bucked the trend set by its two peers, rising 3% near noon... In addition to JPMorgan, Dow member Johnson & Johnson (JNJ) reported on its third quarter earnings. The drug and medical device giant reported better than expected profits and revenues and raised its FY14 EPS outlook, but the stock was fractionally lower near midday. MAJOR MOVERS: Among the notable gainers was Energy Transfer Equity (ETE), which gained 8.5% after the stock was among the energy industry names upgraded this morning at RW Baird. Also higher was Skyworks (SWKS), which rose 11% after the company preannounced stronger than expected results that its CEO attributed to the "broad-based strength" of its business. Among the noteworthy losers was EnerNOC (ENOC), which dropped 11% after JPMorgan downgraded the stock to Neutral citing risk to the company's Demand Response revenue at PJM given the challenge to FERC Rule 745. Also lower was Tyco (TYC), which fell nearly 4% after Barclays downgraded the stock citing valuation and coupled the ratings change with an upgrade of Eaton (ETN). INDEXES: Near midday, the Dow was up 133.38, or 0.82%, to 16,454.45, the Nasdaq was up 60.63, or 1.44%, to 4,274.29, and the S&P 500 was up 21.51, or 1.15%, to 1,896.25.
11:23 EDTBMY, PFE, NVS, JNJ, TEVA, GSKBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
11:11 EDTJNJJohnson & Johnson Ortho strength positive for Zimmer, says Piper Jaffray
Piper Jaffray said Johnson & Johnson's (JNJ) sequential Q3 strength in orthopedics, which included acceleration in both hips and knees, was surprising and a positive for Zimmer (ZMH). However, Piper expect sentiments on ortho names to remain muted until further into reporting season, noting that Stryker (SYK) is scheduled to report Thursday after the close. The firm has Neutral rating on Johnson & Johnson and Stryker and an Overweight rating on Zimmer.
10:51 EDTJNJGilead weakness a buying opportunity, says RBC Capital
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10:41 EDTJNJGilead weakness a buying opportunity, says RBC Capital
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10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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10:05 EDTJNJAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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09:14 EDTJNJJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
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09:13 EDTJNJOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Johnson & Johnson (JNJ), up 1%... Dominos Pizza (DPZ), up 2.7%. ALSO HIGHER: Citigroup (C), up 2.5% following earnings report, announcement of plans to exit consumer businesses in 11 markets... MagneGas (MNGA), up 14% after signing Letter of Intent with Pioneer Recycling... Skyworks (SWKS), up 6% after raising its outlook for Q4. Shares of peers Avago (AVGO), NXP Semiconductors (NXPI) and RF Micro Devices (RFMD) are also moving higher in pre-market trading after Skyworks pointed to "broad-based strength" of its business in raising its outlook... Halcon Resources (HK), up 6% after upgraded at KLR Group... Quantum (QTM), up 8.8% after issuing Q2 earnings guidance. LOWER: Wells Fargo (WFC), down 1.4% after reporting in-line Q3 earnings... JPMorgan (JPM), down 1.8% after Q3 headline earnings miss... Las Vegas Sands (LVS), down 1% following downgrade at BofA Merrill Lynch.
08:58 EDTJNJJ&J sees FY14 operating sales on constant currency basis up 5.5%-6.5%
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07:50 EDTJNJJohnson & Johnson: Alios BioPharma transaction expected to close in Q4 of 2014
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07:50 EDTJNJJohnson & Johnson reports Q3 Worldwide Consumer sales down 0.6% to $3.6B
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07:49 EDTJNJJohnson & Johnson raises FY14 EPS to $5.92-$5.97 from $5.85-$5.92
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07:48 EDTJNJJohnson & Johnson reports Q3 domestic sales up 11.6% to $8.84B
Reports Q3 international sales down 0.3% to $9.63B. Worldwide, domestic and international operational sales growth, excluding the impact of this divestiture, was 8.4%; 14.8% and 3.1% respectively.
07:46 EDTACTActavis should be able to mitigate Irish tax downside, says Leerink
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07:46 EDTJNJJohnson & Johnson reports Q3 adjusted EPS $1.50, consensus $1.44
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06:03 EDTACTMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
October 13, 2014
15:24 EDTJNJNotable companies reporting before tomorrow's open
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15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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14:24 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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14:15 EDTJNJEarnings Preview: Johnson & Johnson looks to new drugs to boost Q3 sales
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14:08 EDTJNJJohnson & Johnson technical notes before earnings
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08:40 EDTJNJAlios BioPharma reports positive results for AL-8176 in Phase 2 study
Alios BioPharma presented results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176 this past weekend at the IDWeek 2014 Conference in Philadelphia, PA. The study was conducted in healthy adult volunteers who were infected intranasally with respiratory syncytial virus, or RSV. AL-8176 achieved its primary and secondary endpoints of reduction in viral load and improvement in symptom scores as compared to placebo. AL-8176 was well tolerated with no discontinuations of study drug and no clinically significant laboratory abnormalities. In successfully infected subjects, a rapid and marked reduction in RSV viral load was observed following treatment in all three AL-8176 treated dose groups as compared to placebo. In contrast, successfully infected placebo subjects exhibited a logarithmic increase in RSV RNA with a peak viral load at Day 3.5 following start of dosing with placebo. The mean time to non-detectability of RSV RNA was 1.3-2.3 days for the AL-8176 treatment groups compared to 7.2 days in the placebo group. At discharge, all subjects treated with AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable upon follow-up on Days 16 and 28. The viral load reduction in infected subjects across all AL-8176 dosing regimens was associated with concomitant improvements in RSV symptom scores and reductions in mucus weight. On September 30, Johnson & Johnson announced a definitive agreement to acquire Alios.
08:05 EDTJNJ, BMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:25 EDTJNJEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
07:15 EDTJNJNational Association of Corporate Directors to hold a conference
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07:13 EDTJNJ, BMYBioFlorida to hold a conference
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07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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October 10, 2014
10:20 EDTACTFidelity supports potential merger between Actavis and Allergan, Reuters reports
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10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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10:01 EDTJNJOn The Fly: Analyst Upgrade Summary
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08:19 EDTJNJ, BMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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08:15 EDTJNJJohnson & Johnson reports additional data from ATTAIN study
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08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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07:37 EDTACTActavis more likely partner than Valeant if Allergan merges, says UBS
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07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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06:27 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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12:28 EDTACTAllergan price target raised to $230 from $210 at BTIG
BTIG said it expected Allergan to beat the consensus forecast for Q3 EPS, but not by as much as it did, and the firm did not expect the company to raise its future EPS outlook yet again. BTIG feels the stock's move higher indicates Valeant (VRX) or Actavis (ACT) would need to bid above $200 if they hope to buy the company. BTIG maintains its Buy rating on Allergan and raised its price target on the stock to $230 from $210.
11:14 EDTACTAllergan raises outlook again as Valeant pursuit continues
Drug maker Allergan (AGN) this morning preannounced stronger than expected results and again raised its fiscal year profit guidance. The beat and raise results come after The Wall Street Journal reported on Tuesday that drug maker Valeant (VRX) and hedge fund Pershing Square intend to raise their previous bid for Allergan by $15 per share to about $191. Meanwhile, also on Tuesday, Reuters said that drug maker Actavis (ACT) plans to make a new merger offer to Allergan, and sources indicated to the news service that Allergan may be willing to consider an offer from Actavis if the bid is for more than $200 per share. WHAT'S NEW: Allergan estimated that its third quarter earnings per share would come in at $1.76-$1.78, versus analysts' consensus estimate of $1.48. The drug maker had previously provided Q3 EPS guidance of $1.44-$1.47. Allergan raised its fiscal 2014 EPS guidance to $6.20-$6.25 from $5.74-$5.80. Analysts' consensus estimate was $5.81. This is the fourth time that Allergan has raised its guidance this year. Allergan said that its markets have been strong around the world, while it is gaining market share in most categories. ANALYST REACTION: In a note to investors today, Wells Fargo analyst Larry Biegelsen wrote that, in the wake of Allergan's guidance increase, the company's price to earnings multiple could expand to 22x its estimated 2016 earnings, up from its current multiple of 19x. In addition to the raised guidance, a potential accretive acquisition by Allergan and the possibility that it will be acquired make such an increase in the multiple "quite possible," Biegelsen contended. He kept an Outperform rating on the stock. WHAT'S NOTABLE: Allergan has reportedly held advanced talks about acquiring another company in the sector, Salix (SLXP), although CNBC's David Faber on October 2 reported that the talks between the two companies about a merger had "cooled considerably." PRICE ACTION: In late morning trading, Allergan rose fractionally to $191.06 while Valeant slid 1.5% to $124.08.
08:50 EDTACTAllergan shares have further upside, says Wells Fargo
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07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
10:55 EDTPFELeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:42 EDTACTSalix shares should be bought on weakness, says Sterne Agee
After Reuters yesterday afternoon reported that Actavis (ACT) plans to make a new merger approach to Allergan (AGN), Sterne Agee believes that Salix's standalone value is $162. The firm expects the shares to reach that level following approval of its Xifaxan IBS-D drug after the February 2015 PDUFA date.
08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:19 EDTNVS, PFECBI to hold a conference
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07:18 EDTPFE, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
06:47 EDTACT, MYL, TEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:23 EDTACTActavis more inclined to pursue Allergan over Salix, says Citigroup
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06:11 EDTGSK, NVSNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
15:21 EDTACTAllergan warms to sale as Actavis plans new approach, Reuters says
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15:01 EDTACTAllergan up 1.5% following report on Actavis planned approach on merger
14:59 EDTACTActavis plans new approach to Allergan, Reuters reports
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12:57 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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10:56 EDTMYLOptions with increasing implied volatility
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08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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08:34 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. Bristol-Myers says "The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world. We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases, we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible."
08:33 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
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07:48 EDTACTSalix reinstated with a Buy at Jefferies
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07:48 EDTPFEU.S. Chamber of Commerce to hold a discussion
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07:24 EDTJNJAlliance for Regenerative Medicine
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06:08 EDTJNJJohnson & Johnson Remicade competition could come in 2016, says Wells Fargo
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October 6, 2014
16:20 EDTACTOn The Fly: Closing Wrap
Stocks on Wall Street opened in positive territory and appeared ready to ride the wave of optimism from Friday’s jobs report into the new week. However, with little on the economic calendar to sustain the momentum, each of the major equity indexes had given up their gains by noon. The Dow and S&P 500 made it back to flat late in the session, but weakened into the close to end the day slightly lower. The tech-heavy Nasdaq was the laggard throughout and ended the day with the most significant decline. ECONOMIC EVENTS: In the U.S., no major economic data was reported. COMPANY NEWS: Hewlett-Packard (HPQ) climbed $1.67, or 4.74%, to $36.87 after it confirmed plans to split itself into two publicly traded companies by the end of its fiscal 2015. One company will include HP's technology infrastructure, software and services businesses, to be known as "Hewlett-Packard Enterprise," while the other will include the company's PC and printing businesses and be called "HP Inc." After the announcement, HP shares were upgraded to Outperform from Neutral at Credit Suisse, while analysts at Cantor called the split "a bold and smart move" that will give HP the financial flexibility needed to sell off one or both of the PC and printing businesses if an attractive offer emerges for either or both. MAJOR MOVERS: Among the notable gainers was Durata Therapeutics (DRTX), which surged $10.36, or 74.64%, to $24.24 after the company agreed to be acquired by larger drugmaker Actavis (ACT) for $23.00 per share in cash, or approximately $675M, and contingent value rights for additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product are achieved. Also higher was CareFusion (CFN), which jumped $10.58, or 22.92%, to $56.75 after agreeing to be acquired by Becton Dickinson (BDX) for $49 in cash and 0.0777 of a share of BD for each share of CareFusion, or about $12.2B. Becton Dickinson rose $9.14, or 7.89%, to $124.98 after its deal, while Actavis slipped $2.12, or 0.86%, to $243.95, after its own, much smaller purchase. GT Advanced Technologies (GTAT) plunged $10.22, or 92.46%, to 83c after the company announced that it and some of its units had commenced voluntary cases under chapter 11 of the bankruptcy code, which Raymond James believes implies a "fundamental, severe breakdown" of the company's relationship with Apple (AAPL). Also lower were shares of Sunesis (SNSS), which dropped $5.18, or 78.01%, to $1.46 and was downgraded at RBC Capital and Wells Fargo after a trial of a combination therapy for patients with first relapsed or refractory acute myeloid leukemia did not meet its primary endpoint. INDEXES: The Dow slid 17.78, or 0.1%, to 16,991.91, the Nasdaq fell 20.82, or 0.47%, to 4,454.80, and the S&P 500 slipped 3.08, or 0.16%, to 1,964.82.
12:41 EDTACTOn The Fly: Midday Wrap
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11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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11:15 EDTACTDurata surges after Actavis takeover
Shares of Durata Therapeutics (DRTX) are surging after the drugmaker agreed to be acquired by its larger industry peer, Actavis (ACT). WHAT'S NEW: Actavis announced it will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 per share in cash, or approximately $675M in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product Dalvance are achieved. If Dalvance is approved in Europe for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, holders of the CVR will receive $1.00 per share. If Dalvance is approved for single dose administration by the FDA, holders of the CVR will receive $1.00 per share. If a net global Dalvance revenue threshold is met over a designated time period, holders of the CVR will receive $3.00 per share. Actavis expects the acquisition to be accretive by the end of the first year, it stated. WHAT'S NOTABLE: The acquisition comes after Durata Therapeutics was granted a Special Protocol Agreement by the FDA for its Phase 3 study of Dalvance on October 3. The study was designed to study Dalvance for the treatment of patients with community-acquired pneumonia and pediatric osteomyelitis. ANALYST REACTION: BMO Capital views the acquisition as a "good deal" for Actavis that is in line with CEO Brent Saunders' goal of making investments that complement its existing business. BMO believes the acquisition does not extend Actavis' balance sheet too far, and therefore does not prevent the company from doing additional deals. The firm expects there could be more deal-related news ahead for Actavis. The Fly notes Bloomberg reported on October 2 that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis after failing to reach a deal with Allergan (AGN). PRICE ACTION: During morning trading, Durata Therapeutics gained $9.93, or 71.5%, to $23.81, Actavis slipped $1.95, or 0.8% to $244.12, and Salix fell $4.02, or 2.6%, to $148.85.
11:09 EDTMYLOptions with increasing implied volatility
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09:49 EDTACTActavis purchase of Durata leaves room for future deals, says BMO Capital
BMO Capital views Actavis' (ACT) deal to buy Durata Therapeutics (DRTX) as in line with its strategy of making investments that complement its existing business and as small enough that it does not prevent the company from doing additional deals. BMO expects there could be more deal-related news ahead for Actavis and keeps its Outperform rating on the stock. The Fly notes that that Bloomberg reported last week that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis.
08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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08:07 EDTACTSalix slips in pre-market trade after Actavis strikes deal for Durata
Note that Bloomberg reported on October 2, citing people with knowledge of the matter, that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis (ACT) after failing to reach a deal with Allergan (AGN). Actavis announced this morning that it has reached a deal to acquire Durata Therapeutics (DRTX) for $675M, or $23.00 per share. In pre-market trading, shares of Salix are down nearly 2% to $150 per share.
08:05 EDTACTActavis to acquire Durata Therapeutics for $23.00 per share or $675M
Actavis (ACT) and Durata Therapeutics (DRTX) announced that they have entered into a definitive merger agreement under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 per share in cash, or approximately $675M in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product DALVANCETM are achieved. Actavis expects the acquisition to be accretive by the end of the first year. DALVANCETM was approved by the FDA on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product. A Marketing Authorization Application for dalbavancin is under review with the European Medicines Agency, with a decision anticipated in the first half of 2015. A single-dose regimen of DALVANCETM is also in late-stage development for ABSSSI, with a supplemental New Drug Application filing expected by mid-2015. Durata also has plans to continue the development of DALVANCETM for additional indications, such as hospitalized community-acquired pneumonia and pediatric osteomyelitis. Under the terms of the definitive merger agreement, it is anticipated that Actavis will promptly commence the cash tender offer to purchase all of the outstanding shares of Durata common stock for $23.00 per share in cash, plus CVRs of up to an additional $5.00 per share in the event certain developmental or commercial milestones are met. If DALVANCETM is approved in Europe for ABSSSI, holders of the CVR will receive $1.00 per share. If DALVANCETM is approved for single dose administration by the FDA, holders of the CVR will receive $1.00 per share. If a net global DALVANCETM revenue threshold is met over a designated time period, holders of the CVR will receive $3.00 per share.
08:04 EDTBMY, NVSBristol-Myers announces Opdivo clinical trial with Novartis therapies
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08:04 EDTACTActavis to acquire Durata Therapeutics for $23.00 per share or $675M
08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
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07:30 EDTMYLMylan launches generic Combivir
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05:14 EDTBMY, NVSNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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