New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
<< 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | all recent news | >>
October 20, 2014
18:51 EDTSHPGOn The Fly: After Hours Movers
Subscribe for More Information
18:27 EDTSNYActavis among bidders for Omega Pharma, reports Bloomberg
Subscribe for More Information
17:26 EDTSHPGShire down 1% following termination of merger with AbbVie
Subscribe for More Information
17:17 EDTSHPGAbbVie to pay Shire $1.64B break fee
Subscribe for More Information
17:16 EDTSHPGAbbVie, Shire announce termination of proposed merger
Subscribe for More Information
17:14 EDTSHPGAbbVie, Shire announce termination of proposed merger
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.
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
Subscribe for More Information
12:36 EDTJNJOptions with decreasing implied volatility
Subscribe for More Information
12:23 EDTSHPGAllergan holder Paulson encourages deal with Shire, Reuters says
Subscribe for More Information
12:21 EDTSHPGCooperman says bought Shire as 'small position'
Subscribe for More Information
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the product’s U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
09:22 EDTSHPGOn The Fly: Pre-market Movers
Subscribe for More Information
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).
08:06 EDTSNY, MRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
Subscribe for More Information
07:47 EDTPFE, SHPGPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
Subscribe for More Information
07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:33 EDTSHPGShire upgraded to Buy from Neutral at SunTrust
Subscribe for More Information
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
Subscribe for More Information
07:19 EDTMRK, GSK, SHPG, BMY, SNYIBC Life Sciences to hold a conference
Subscribe for More Information
07:16 EDTSHPGAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:15 EDTSHPG, PFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
Subscribe for More Information
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
Subscribe for More Information
07:11 EDTMRK, PFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFE, SHPG, SNYAmerican Society of Human Genetics to hold annual meeting
Subscribe for More Information
07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
06:56 EDTSHPGShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
Subscribe for More Information
05:29 EDTSHPGShire Interim CFO James Bowling to step down
Shire plc announces that James Bowling, Interim CFO, has notified the board of his decision to step down from his current role to pursue a new career opportunity as CFO of Severn Trent plc. James will leave Shire at the end of 1Q15 and the company will commence a search for a new CFO immediately.
October 17, 2014
16:55 EDTSHPG, JNJStocks end volatile week lower amid oil price plunge
Subscribe for More Information
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
Subscribe for More Information
14:50 EDTNVS, GSKBARDA asks labs to ramp up Zmapp production, Reuters says
Subscribe for More Information
13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
Subscribe for More Information
11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
Subscribe for More Information
10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
Subscribe for More Information
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
Subscribe for More Information
08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
Subscribe for More Information
08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
Subscribe for More Information
07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
07:07 EDTSHPGShire may be buyer instead of target if AbbVie deal breaks, WSJ says
Assuming AbbVie's (ABBV) deal to buy Shire (SHPG) gets cancelled, which appears likely at this point, many analysts and investors believe Shire will become a buyer and Leerink Partners estimates the company could have $10B to use for a takeover deal, reported The Wall Street Journal. AbbVie will also be likely to look for other deals and could be forced to pay up for them, as its top seller, Humira, moves closer to losing patent exclusivity, the Journal said, citing analysts. Reference Link
October 16, 2014
16:29 EDTSHPGShire price target lowered to $198 from $278 at Leerink
Subscribe for More Information
15:10 EDTCELGAmerican 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
Subscribe for More Information
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
08:52 EDTSHPGAbbVie price target lowered to $59 from $71 at BMO Capital
Subscribe for More Information
08:42 EDTBMYBristol-Myers upgraded at BMO Capital
Subscribe for More Information
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
Subscribe for More Information
08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
Subscribe for More Information
07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
Subscribe for More Information
06:17 EDTSHPGJefferies says Medtronic 'needs to do' Covidien takeover
Jefferies says it "can't see how Medtronic walks" from the Covidien (COV) takeover given how compelling the merger is. The firm confirmed with Medtronic (MDT) that nothing has changed in the company's commitment to the deal since new financing terms were announced on October 3. In Jefferies view, "Medtronic needs to do this deal." It notes the spread on the acquisition widened significantly on the news that Abbvie (ABBV) is reconsidering its acquisition of Shire (SHPG).
06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
05:50 EDTSHPGStocks with implied volatility movement; SHPG SIRI
Subscribe for More Information
05:37 EDTSHPGShire releases statement regarding AbbVie withdrawal of recommendation
Subscribe for More Information
05:21 EDTSHPGAbbVie recommends holders vote against Shire transaction
Following Shire's (SHPG) waiver of the three-day notice period, AbbVie (ABBV) announces its board withdraws its recommendation made on July 18 regarding the proposed Shire transaction and recommends that stockholders vote against the transaction. AbbVie and its board made this determination following a detailed consideration of the impact of the U.S. Department of Treasury's unilateral changes to the tax rules, as issued on September 22. The breadth and scope of the changes, including the unexpected nature of the exercise of administrative authority to impact longstanding tax principles, and to target specifically a subset of companies that would be treated differently than either other inverted companies or foreign domiciled entities, introduced an unacceptable level of uncertainty to the transaction. Additionally, the changes eliminated certain of the financial benefits of the transaction, most notably the ability to access current and future global cash flows in a tax efficient manner as originally contemplated in the transaction. This fundamentally changed the implied value of Shire to AbbVie in a significant manner. Under the conditions of AbbVie's offer and the terms of the Co-operation Agreement, the withdrawal of the recommendation alone will not cause a lapse of AbbVie's offer or terminate the Co-operation Agreement between AbbVie and Shire. Unless Shire and the U.K. Takeover Panel agree otherwise, AbbVie must convene an AbbVie stockholder meeting to consider the adoption of the U.S. merger agreement. AbbVie's offer will lapse if the company's stockholders do not adopt the agreement. Assuming Shire provides the requisite cooperation and consents, a pre-effective amendment to the registration statement filed by AbbVie Private Limited in connection with the combination is expected to be filed with the SEC as soon as practicable. Under the terms of the Co-operation Agreement, following the withdrawal of the AbbVie Board of Directors' recommendation, a break fee of approximately $1.64B will be payable to Shire if either: AbbVie stockholders do not approve the adoption of the U.S. merger agreement at an AbbVie stockholder meeting; or such a meeting does not occur by December 14.
October 15, 2014
17:17 EDTSHPGAbbVie, Shire both look like buys no matter what, Barron's says
AbbVie (ABBV) and Shire (SHPG) both offer great value and are buys even without a merger, Barron's argues in its 'Barron's Take' column. Reference Link
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%.
16:37 EDTSHPGOn The Fly: Closing Wrap
The market opened sharply lower amid sliding oil prices, worse than expected economic data, and the potential for a major M&A deal to fall apart due to tax inversion rule changes. The Dow fell more than 350 points within the first 30 minutes of trading, but then bounced back to move above its opening level. The volatility did not end there, however, as the market swung several more times during the session. The S&P 500's drop wiped out its gains for the year at one point, but a late day rally significantly cut the losses for the major averages. ECONOMIC EVENTS: In the U.S., retail sales, which were expected to be down 0.1% in September, actually fell 0.3% in the month and slipped 0.2% excluding autos. The Producer Price Index for final demand decreased a seasonally adjusted 0.1% in September from the prior month, marking the first decline in the measure in over a year. The core PPI reading, which excludes food and energy, was unchanged, versus expectations for a 0.1% rise. New York's Empire State manufacturing index fell 21.4 points to 6.2 in October, severely missing the expectation for a narrower pullback to a reading of 20. Business inventories rose 0.2% in August, versus expectations for an increase of 0.4%. In China, the consumer price index climbed 1.6% in September from a year earlier, which was below the consensus projection for 1.7% inflation and down from 2% inflation in August. China's PPI plunged 1.8% year-over-year in September, which was more than the 1.6% slide expected and an acceleration of the 1.2% year-on-year decline in August. COMPANY NEWS: Shares of Shire (SHPG) plunged $74.08, or 30.29%, to $170.49 after AbbVie's (ABBV) board last night stated that it was reconsidering its recommendation that the company's shareholders back a takeover of Irish drugmaker in light of the potential impact of tax rule changes on the deal. During the day, Bloomberg reported that people familiar with the matter say AbbVie is close to abandoning its $51B takeover bid, while Shire announced that it has agreed to waive the requirement for three business days' notice for AbbVie's board to meet to consider its offer. In contrast, AbbVie ended the session up 50c, or 0.92%, at $54.63... Wal-Mart (WMT) held its annual meeting, during which it lowered its fiscal year 2015 net sales growth forecast to 2%-3%, citing a tougher sales environment than it anticipated a year ago. The company indicated in February that it expected net sales growth to be at the low end of its guidance provided last October of 3%-5%. The world's largest retailer also cut its planned retail square foot growth expectations, due to a moderation of large format store growth and accelerated e-commerce investments. Following the outlook revisions, Wal-Mart closed down $2.78, or 3.57%, to $75.20. MAJOR MOVERS: Among the notable gainers was Penford Corporation (PENX), which jumped $7.60, or 69.15%, to $18.59 after the company agreed to be acquired by Ingredion (INGR) for $340M, or $19.00 in cash per share. Also higher was Southwestern Energy (SWN), which rose $2.59, or 7.82%, to $35.69 after it was among a number of oil and gas exploration and production names upgraded by analysts at Bank of America Merrill Lynch. Among the noteworthy losers was Nu Skin (NUS), which dropped $4.47, or 9.13%, to $44.50 after the company disclosed new debt arrangements that come with certain restrictions, including restrictions on the payment of dividends. Also lower were shares of Covidien (COV), which fell $6.50, or 7.04%, to $85.86 in the wake of the news for Shire and AbbVie, which investors may have read as jeopardizing Covidien's deal to be bought by Medtronic (MDT). Note that on October 3 Medtronic announced that it intends to use approximately $16B in external financing to complete the acquisition of Covidien and said the strategic benefits of the transaction "remain compelling" despite the additional expense of the new financing. INDEXES: The Dow dropped 173.45, or 1.06%, to 16,141.74, the Nasdaq slipped 11.85, or 0.28%, to 4,215.32, and the S&P 500 fell 15.21, or 0.81%, to 1,862.49.
15:00 EDTSHPG, PFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
Subscribe for More Information
13:45 EDTSHPGShire waives notice requirement for AbbVie board meeting
Shire (SHPG) announces that, in order to "allow the period of uncertainty for its shareholders, employees and other stakeholders to be reduced," it has agreed to waive the requirement for three business days' notice for AbbVie's (ABBV) board to meet to consider its recommendation of the offer for Shire.
13:19 EDTSHPGAbbVie close to dropping takeover bid for Shire, Bloomberg reports
Subscribe for More Information
12:59 EDTSHPGShire at lows down 33% after Bloomberg says AbbVie close to dropping bid
Subscribe for More Information
12:58 EDTSHPGAbbVie close to dropping takeover bid for Shire, Bloomberg reports
12:42 EDTMRKNY AG announces $31M Medicaid settlement with Organon
Subscribe for More Information
12:36 EDTSHPGOn The Fly: Midday Wrap
Subscribe for More Information
10:48 EDTSHPG, ABTShire tanks with AbbVie calling board meeting over merger
Subscribe for More Information
10:02 EDTSNY, SHPGOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
09:57 EDTBMY, JNJ, MRKLeerink biotech analysts hold an analyst/industry conference call
Subscribe for More Information
09:38 EDTJNJActive equity options trading on open
Subscribe for More Information
09:20 EDTSHPGOn The Fly: Pre-market Movers
Subscribe for More Information
09:15 EDTJNJJ&J comments positive for Anika Therapeutics, says Summer Street
Subscribe for More Information
09:11 EDTSHPGShire upgraded to Buy from Fair Value at CRT Capital
Subscribe for More Information
07:37 EDTJNJJohnson & Johnson pullback a buying opportunity, says Leerink
Subscribe for More Information
07:34 EDTJNJJohnson & Johnson reported strong Q3 results, says Argus
Subscribe for More Information
07:30 EDTSHPGAbbVie review of Shire deal an 'unwelcome surprise,' says Jefferies
Subscribe for More Information
07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
Subscribe for More Information
07:14 EDTJNJJohnson & Johnson price target lowered to $110-$111 from $119-$120 at Wells Fargo
Subscribe for More Information
06:58 EDTSHPGAbbVie volatility elevated into reconsidering Shire merger
Subscribe for More Information
06:55 EDTSHPGShire volatility elevated into AbbVie reconsidering merger recommendation
Subscribe for More Information
05:34 EDTSHPGShire says AbbVie should proceed with recommended offer
Subscribe for More Information
05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
19:50 EDTSHPGShire down nearly 6% following AbbVie reconsidering merger recommendation
Subscribe for More Information
19:48 EDTSHPGAbbVie board reconsidering recommendation to holders to accept Shire merger
Subscribe for More Information
19:46 EDTSHPGAbbVie board reconsidering recommendation to holders to accept Shire merger
Subscribe for More Information
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
Subscribe for More Information
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
Subscribe for More Information
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 EDTGSK, JNJ, MRK, SNY, BMY, PFE, NVSBIND Therapeutics and The Conference Forum hold a conference
Subscribe for More Information
11:19 EDTGSKNIH says several potential Ebola treatments under development
Subscribe for More Information
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
Subscribe for More Information
10:41 EDTJNJGilead weakness a buying opportunity, says RBC Capital
Subscribe for More Information
10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
Subscribe for More Information
10:05 EDTJNJAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
Subscribe for More Information
09:14 EDTJNJJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
Subscribe for More Information
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.
09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
Subscribe for More Information
08:58 EDTJNJJ&J sees FY14 operating sales on constant currency basis up 5.5%-6.5%
Subscribe for More Information
08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
07:50 EDTJNJJohnson & Johnson: Alios BioPharma transaction expected to close in Q4 of 2014
Subscribe for More Information
07:50 EDTJNJJohnson & Johnson reports Q3 Worldwide Consumer sales down 0.6% to $3.6B
Subscribe for More Information
07:49 EDTJNJJohnson & Johnson raises FY14 EPS to $5.92-$5.97 from $5.85-$5.92
Subscribe for More Information
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 EDTJNJJohnson & Johnson reports Q3 adjusted EPS $1.50, consensus $1.44
Subscribe for More Information
October 13, 2014
15:24 EDTJNJNotable companies reporting before tomorrow's open
Subscribe for More Information
14:24 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
Subscribe for More Information
14:15 EDTJNJEarnings Preview: Johnson & Johnson looks to new drugs to boost Q3 sales
Subscribe for More Information
14:08 EDTJNJJohnson & Johnson technical notes before earnings
Subscribe for More Information
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 EDTBMY, JNJBristol-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
Subscribe for More Information
07:37 EDTMRKAmerican Society of Anesthesiologists to hold annual meeting
Subscribe for More Information
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
Subscribe for More Information
07:13 EDTBMY, JNJBioFlorida to hold a conference
Subscribe for More Information
07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
Subscribe for More Information
October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
Subscribe for More Information
10:01 EDTJNJOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
08:41 EDTCELGCelgene reports apremilast significantly improved preexisting psoriasis in study
Subscribe for More Information
08:39 EDTCELGCelgene says data show Apremilast treatment resulted in improved quality of life
Subscribe for More Information
08:19 EDTJNJ, BMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
Subscribe for More Information
08:15 EDTJNJJohnson & Johnson reports additional data from ATTAIN study
Subscribe for More Information
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
Subscribe for More Information
07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
Subscribe for More Information
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
08:32 EDTMRKMerck HCV solutions becoming more credible, says Bernstein
Subscribe for More Information
07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
Subscribe for More Information
05:22 EDTSHPGShire provides regulatory update on SHP 465
Subscribe for More Information
October 8, 2014
11:14 EDTMRKMerck presents new MK-5172/MK-8742 clinical study data
Merck announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir, or MK-5172/MK-8742, are scheduled to be presented at the 65th American Association for the Study of Liver Diseases Annual Meeting, also known as The Liver Meeting. The meeting is scheduled to take place from November 7-11. New data will also be presented for MK-3682, formerly IDX21437, as part of its purchase of Idenix Pharmaceuticals.
11:08 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses IMPROVE-IT's regulatory and commercial implications for novel LDL-lowering therapies on an Analyst/Industry conference call to be held on October 9 at 2 pm.
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 EDTPFE, MRKLeerink 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.
08:09 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.
08:03 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 EDTPFE, NVSCBI to hold a conference
Subscribe for More Information
07:18 EDTSNY, MRK, PFE, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
07:11 EDTCELGEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
06:11 EDTNVS, GSKNovartis 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
12:57 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
Subscribe for More Information
08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
Subscribe for More Information
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
Subscribe for More Information
07:54 EDTSNYSanofi says alerted U.S. authorities about allegations of impropriety, WSJ says
Subscribe for More Information
07:48 EDTPFEU.S. Chamber of Commerce to hold a discussion
Subscribe for More Information
07:31 EDTCELGCelgene to present long-term efficacy and safety data on oral Otezla
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the latest research findings on OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology Congress in Amsterdam, October 8 – 12. In total, 11 abstracts will be presented at the meeting. OTEZLA data to be presented include long-term results from Celgene’s pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus, difficult-to-treat areas such as nail and scalp, and palmoplantar psoriasis, work productivity and improvements in health-related quality of life. An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis.
07:24 EDTCELG, JNJAlliance for Regenerative Medicine
Subscribe for More Information
06:08 EDTJNJJohnson & Johnson Remicade competition could come in 2016, says Wells Fargo
Subscribe for More Information
October 6, 2014
09:25 EDTSNYOn The Fly: Pre-market Movers
HIGHER: HP (HPQ), up 5% after confirming plans to separate into two companies... CareFusion (CFN), up 24% after Becton Dickinson (BDX) agreed to acquire the company for $58 per share in $12.2B deal. Becton Dickinson shares are up 7% following the news... Chimerix (CMRX), up 7% after announcing announced that brincidofovir has been provided for potential use in patients with Ebola Virus Disease... Conn's (CONN), up 6.5% after announcing that it is exploring strategic alternatives... TASER (TASR), up 5% after announces multiple orders of TASER Smart Weapons... Tableau (DATA), up 3.5% after upgraded at Morgan Stanley... Splunk (SPLK), up 3.9% after upgraded at Morgan Stanley... Unilife (UNIS), up 52% after signing a 15-year commercial supply agreement with Sanofi (SNY). LOWER: RadioShack (RSH), down 5% after confirming definitive agreements to restructure debt... Alcobra (ADHD), down 43% after announcing results from Phase III study of MDX in adult ADHD... Sunesis (SNSS), down 71% after announcing Phase 3 VALOR trial did not meet primary endpoint... H&R Block Bank (HRB), down 5% after deal with BofI (BOFI) not expected to get regulatory approval this year. Tekmira (TKMR), down 8% after downgraded at Leerink.
08:04 EDTNVS, BMYBristol-Myers announces Opdivo clinical trial with Novartis therapies
Subscribe for More Information
08:02 EDTSNYUnilife signs 15-year commercial supply agreement with Sanofi
Subscribe for More Information
08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
Subscribe for More Information
07:34 EDTCELGAlliqua expands exclusive licensing agreement with Celgene
Alliqua Biomedical (ALQA) announced that the company has amended its exclusive licensing agreement with Celgene Cellular Therapeutics, or CCT, a subsidiary of Celgene (CELG). Under the terms of the amended agreement, Alliqua has received the right to market the advanced wound care product, Biovance, for podiatric and orthopedic applications. Biovance is a, decellularized, and dehydrated, human amniotic membrane allograft, which was commercially launched by Alliqua on April 23. The product is currently indicated for the management of non-infected partial- and full-thickness wounds, including chronic and acute wounds such as diabetic ulcers, pressure ulcers, venous ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds, trauma wounds, and draining wounds, The field of use for Biovance has been expanded to include podiatric and orthopedic applications including sports medicine-related conditions pertaining to use during the repair of tendon, nerve and bone in the foot and ankle, as well as other surgical procedures in these specialty areas.
07:19 EDTSNYLeerink healthcare analysts hold an analyst/industry conference call
Healthcare Analysts discuss PCSK9 antibodies and evaluate the commercial potential and unmet need on an Analyst/Industry conference call. Relevant companies Amgen, Sanofi and Regeneron may be discussed on the Analyst/Industry conference call being held on October 6 at 11 am.
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.
<< 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use