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News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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May 27, 2015
17:49 EDTOREXZosano Pharma elects Orexigen's Joseph Hagan to board of directors
Zosano Pharma (ZSAN) announced earlier the election of Joseph Hagan to its board of directors, effective May 22. Hagan is EVP, Chief Business & Financial Officer of Orexigen Therapeutics (OREX). Bruce Steel, chairman of Zosano, remarked that Hagan is "a seasoned business and financial executive with a significant track record in complex partnerships and transactions who will add additional breadth of perspective to our board as Zosano advances its clinical development programs in osteoporosis, hypoglycemia and migraine."
13:28 EDTJNJFBI investigating Johnson & Johnson over discontinued surgical tool, WSJ says
The FBI is investigating Johnson & Johnson over whether it knew about the potential hazards of a surgical device known as a laparoscopic power morcellator before the device was pulled from the market in 2014, reports The Wall Street Journal, citing three people with knowledge of the matter. The Journal notes that the U.S. FDA recommended a "black box" warning for the device in November, stating that it should not be used on the "vast majority" of women because morcellators can spread malignant cancer and worsen patient outcomes. Reference Link
13:10 EDTJNJJ&J being probed by FBI over discontinued surgical device, DJ reports
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12:36 EDTSNYOn The Fly: Top stock stories at midday
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08:01 EDTSNYRetrophin agrees to sell Pediatric PRV to Sanofi
Retrophin (RTRX) announced an agreement to sell its Rare Pediatric Disease Priority Review Voucher to Sanofi (SNY). Retrophin received the Pediatric PRV when Cholbam was approved by the U.S. FDA for the treatment of pediatric and adult patients suffering from bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. Upon closing of the transaction, Retrophin will receive a payment of $150M, followed by two equal installments of $47.5M in 2016 and 2017. The company will receive a total consideration of $245M in cash from Sanofi in exchange for the Pediatric PRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
05:49 EDTMRKStocks with implied volatility movement; MRK EFA
Stocks with implied volatility movement; Merck (MRK) 19, iShares MSCI EAFE Index Fund (EFA) 16 according to iVolatility.
May 26, 2015
16:18 EDTAMGNAmgen announces publication of previous OPTiM data, says met primary endpoint
Amgen announced the publication of primary results from the phase 3 OPTiM study in the Journal of Clinical Oncology. The data published in JCO, which were previously presented at the annual meetings of the American Society of Clinical Oncology in 2013 and 2014, demonstrated a significantly higher durable response rate in patients with unresected stage IIIB, IIIC or IV metastatic melanoma receiving the investigational oncolytic immunotherapy talimogene laherparepvec compared to those who received granulocyte-macrophage colony-stimulating factor. Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival was not met, although there was a strong trend in favor of talimogene laherparepvec. A DRR measures the number of patients who had a complete response or partial response within the first 12 months of treatment and maintained the response continuously for at least 6 months. The most frequent adverse events observed in this study were chills, pyrexia, injection-site pain, nausea, flu-like symptoms and fatigue. The most common serious AEs included disease progression, cellulitis and pyrexia. No treatment-related deaths were observed. The OPTiM data serve as the basis of a BLA which has been accepted for review by the U.S. FDA and a Marketing Authorization Application in the EU for talimogene laherparepvec for the treatment of adults with regionally or distantly metastatic melanoma. The FDA has set a review goal date of October 27.
16:01 EDTMRKOptions Update; May 26, 2015
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14:07 EDTPFEFDA approves request for updated package insert for Prevnar 13
The FDA approved a request from Pfizer's Wyeth Pharmaceuticals to supplement the biologics license application for Pneumococcal 13-valent Conjugate Vaccine, or Prevnar 13, to update the package insert to include data from the CAPiTA confirmatory efficacy study in adults. Reference Link
09:23 EDTAMGNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up marginally after reporting third quarter results. ALSO HIGHER: Geeknet (GKNT), up 119.7% after being acquired by Hot Topic for $17.50 per share... IntelliPharmaCeutics (IPCI), up 16.8% after being granted fast track designation for Rexista Oxycodone by FDA... McDermott (MDR), up 9.2% after favorable mention in Barron's and after being awarded a project for 12 jackets offshore Saudi Arabia... Time Warner Cable (TWC), up 5.2% following announcement of merger with Charter (CHTR)... Charter is up fractionally. DOWN AFTER EARNINGS: Sky-mobi (MOBI), down 7.9%. ALSO LOWER: Etsy (ETSY), down 5.7% following a Wall Street Journal report that Amazon.com (AMZN) is targeting Etsy with an artisan goods marketplace... First Solar (FSLR), down 4.1% after being downgraded to Underperform from Sector Perform at RBC Capital... AstraZeneca (AZN), down 1.9% after Amgen (AMGN) ends participation in co-development and commercialization of brodalumab... Amgen is down 1.5%.
08:14 EDTSHPG, JNJ, SNYBoston Biotech Conferences to hold a conference
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08:03 EDTINFIInfinity Pharmaceuticals reports preclinical data for duvelisib
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08:01 EDTSNYSanofi's Genzyme to present Aubagio, Lemtrada data at CMSC
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07:59 EDTINFIInfinity Pharmaceuticals participates in a conference call with JPMorgan
Conference call with CEO Perkins will be held on May 26 at 10 am hosted by JPMorgan.
06:36 EDTMRKMerck announces Simponi received CHMP positive opinion
MSD, known as Merck & Co., in the U.S. and Canada, announced that SIMPONI has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein, or CRP, and/or magnetic resonance imaging evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI.
May 22, 2015
16:24 EDTAMGNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
10:52 EDTJNJ, MRK, PFE, SNYJPMorgan says Actavis shares cheap compared to peers
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08:17 EDTJNJJohnson & Johnson reports STELARA receives CHMP positive opinion
Janssen-Cilag announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending approval for the use of STELARA for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
07:32 EDTAMGNAmgen receives positive CHMP opinion for use of Repatha
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
07:22 EDTMRKMerck receives positive CHMP opinion for Pembrolizumab in advanced melanoma
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07:15 EDTMRKMerck receives positive CHMP opinion for KEYTRUDA in advanced melanoma
Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.
May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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14:48 EDTAMGN, SNYRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
10:12 EDTOREXOptions with decreasing implied volatility
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07:37 EDTPFE, SHPGPfizer replaces AbbVie as top global pharma pick at Jefferies
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06:38 EDTNVONovo Nordisk rejects claims made by Baxter, Reuters says
Novo Nordisk (NVO) rejects claims made by Baxter (BAX) that the company used substances made by Baxter in its Novoeight haemophilia treatment, following Monday's ITC investigation announcement, reports Reuters, citing an email from Novo Nordisk. Reference Link
05:15 EDTSNYRegeneron, Sanofi announce positive topline results from sarilumab Phase 3 study
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May 20, 2015
16:26 EDTJNJOn The Fly: Top stock stories for Wednesday
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10:26 EDTNVO, JNJJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
09:52 EDTAMGNAlliance for Health Reform holds a webcast on biosimilars
"Biosimilars in the U.S.: Current & Emerging Issues" provides essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future. Speakers include Chief Scientific Officer Ramachandra from Hospira, Executive Director Eich from Amgen on the briefing being held on May 20 at 12 pm. Webcast Link
09:07 EDTJNJJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
08:49 EDTJNJJohnson & Johnson: Priorities for free cash flow include dividends, repurchases
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08:30 EDTJNJAchillion price target lowered to $16 from $25 at Leerink
Leerink says Achillion's deal with Johnson & Johnson (JNJ) increases the probability that it will be a competitive commercial-stage player in hepatitis C. The firm believes the collaboration limits share downside as well as upside by making the "home-run scenario of great combo data leading to an acquisition less likely." It lowered its price target for Achillion shares to $16 and keeps an Outperform rating on the name.
08:15 EDTJNJJohnson & Johnson CEO Alex Gorsky says won't pursue pure-play strategy
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08:02 EDTJNJJohnson & Johnson to hold a meeting
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07:51 EDTJNJAchillion shares remain undervalued after HCV pact with J&J, says Cowen
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07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
07:33 EDTJNJJ&J to file more than 10 new '$1B potenital' products by 2019
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07:30 EDTJNJAchillion downgraded on valuation at JMP Securities
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06:17 EDTJNJAchillion downgraded to Neutral from Buy at UBS
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May 19, 2015
16:10 EDTJNJAchillion enters into collaboration for HCV with Janssen
Achillion (ACHN) announced that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus, or HCV, assets which include ACH-3102, ACH-3422, and sovaprevir. Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets. A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation – JJDC, Inc. will invest $225M in Achillion and, in return, receive approximately 18.4M newly issued, unregistered shares of Achillion at a price of $12.25 per share. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.
08:57 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:51 EDTAMGNFDA PDUFA Date for Amgen's Blinatumomab is May 19, 2015
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07:28 EDTMRKUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
06:55 EDTSNY, PFE, MRKGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
12:34 EDTSNYRegeneron, Sanofi announce positive pivotal Phase 2b dupilumab data in asthma
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07:22 EDTINFIUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link
May 17, 2015
14:59 EDTSNYL'Oreal CEO 'ready' to sell Sanofi stake if needed, Barron's says
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May 15, 2015
12:13 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Yum! Brands (YUM), NXP Semiconductors (NXPI), FedEx (FDX), McKesson (MCK), and J M Smucker (SJM). INCREASED STAKES: Actavis (ACT), Roper Technologies (ROP), Delta Air Lines (DAL), and FleetCor Technologies (FLT). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Phillips 66 (PSX), eBay (EBAY), and Anheuser Busch Inbev SA (BUD). LIQUIDATED STAKES: Alibaba Group (BABA), Citigroup (C), EMC Corporation (EMC), Anglo American (AAL), and Williams Companies (WMB).
11:08 EDTSHPGOmega Advisors gives quarterly update on stakes
NEW STAKES: Targa Resources (TRGP), Targa Resources Partners (NGLS), Humana (HUM), Dow Chemical (DOW), and Twenty-First Century Fox (FOXA). INCREASED STAKES: Kinder Morgan (KMI), Chimera Investment Corporation (CIM), AerCap Holdings (AER), Shire (SHPG), and KKR & Co. (KKR). DECREASED STAKES: eBay (EBAY), Altisource Portfolio Solutions (ASPS), Caesars Entertainment (CZR), Navient (NAVI), and TerraForm Power (TERP). LIQUIDATED STAKES: HCA Holdings (HCA), Gilead (GILD), Cabot Oil & Gas (COG), and Apple (AAPL).
10:29 EDTAGN, SNYAmerican Urological Association to hold an annual meeting
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09:31 EDTPFEAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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05:32 EDTAMGNAmgen presents first Phase 2 data for AMG 334
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May 14, 2015
14:54 EDTJNJJohnson & Johnson unit reports results of VENTURE-AF trial
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12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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10:41 EDTAMGNAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:41 EDTJNJLeerink medical devices analyst holds a cardiology luncheon meeting
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09:22 EDTMRKLeerink pharma/biotech analysts hold an analyst/industry conference call
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08:39 EDTPFETargacept, Catalyst Biosciences amend definitive merger agreement
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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07:44 EDTAMGNInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
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