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Stock Market & Financial Investment News

News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
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May 27, 2015
12:10 EDTTEVATeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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08:24 EDTTEVAFDA reports paragraph IV patent challenge received for Treanda
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07:12 EDTACORAcorda Therapeutics provides update on status of PLUMIAZ nasal spray program
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May 26, 2015
20:50 EDTCELGBernstein to hold a conference
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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 EDTAZNOn 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%.
07:39 EDTCELGCelgene management to meet with SunTrust
Group dinner to be held in New York on May 27 hosted by SunTrust.
May 22, 2015
16:24 EDTAZNAmgen 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 EDTAZN, PFEJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
12:40 EDTAZNHayman's Bass requests review of POZEN patents
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10:58 EDTAZNDeutsche Bank biotech analyst holds an analyst/industry conference call
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09:58 EDTALKSOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Alibaba (BABA) initiated with an Outperform at Bernstein... Alkermes (ALKS) initiated with an Overweight at Barclays... Burlington Stores (BURL) initiated with an Outperform at FBR Capital... Crocs (CROX) initiated with a Neutral at B. Riley... Darling (DAR) initiated with a Buy at Roth Capital... Dynegy (DYN) initiated with an Outperform at RBC Capital... Esperion (ESPR) initiated with an Overweight at Barclays... Five Below (FIVE) initiated with a Market Perform at FBR Capital... Intercept (ICPT) initiated with an Overweight, $450 target at Barclays... Johnson Matthey (JMPLY) initiated with a Buy at Jefferies... Nike (NKE) initiated with a Buy at Jefferies... RTI Surgical (RTIX) initiated with a Buy at Sidoti... TeleNav (TNAV) initiated with an Outperform at Northland... Trevena (TRVN) initiated with an Equal Weight at Barclays... Vectrus (VEC) initiated with a Hold at Stifel.
08:08 EDTCELGAgios Pharmaceuticals to present data at 20th Congress of EHA
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07:37 EDTAZN, PFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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05:37 EDTALKSAlkermes initiated with an Overweight at Barclays
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May 20, 2015
11:51 EDTAZNExpress Scripts' Medco to pay $7.9M to resolve kickback allegations
Medco Health Solutions, a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company (ESRX), of Missouri, has agreed to pay the government $7.9M to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced. Medco provides pharmacy benefit management services to clients who receive subsidies under the Medicare Retiree Drug Subsidy program. The settlement resolves allegations that Medco solicited remuneration from AstraZeneca, a pharmaceutical manufacturer, in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on certain of Medco’s prescription drug lists known as formularies. The United States alleged that Medco received some or all of the remuneration from AstraZeneca in the form of reduced prices on the following AstraZeneca drugs: Prilosec, Toprol XL and Plendil. The United States contended that this kickback arrangement between Medco and AstraZeneca (AZN) violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program. In January 2015, the United States and AstraZeneca reached a $7.9M settlement to resolve kickback allegations arising out of the same conduct. This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, whose share of the settlement has not been determined. The settlement with Medco was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office of the District of Delaware and HHS-OIG.
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.
May 19, 2015
15:05 EDTAZNArdelyx scheduled for end Phase 2 meeting with FDA scheduled in June
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08:17 EDTCELGCelgene says patients experienced clinical remission in Phase II GED-0301 trial
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06:55 EDTPFEGenocea 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.
06:08 EDTTEVAPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 18, 2015
08:44 EDTCELGCelgene data positive, says SunTrust
SunTrust believes that data presented for Celgene's GED-0301 in Crohn's indicated that the drug is effective irrespective of baseline disease severity and CRP levels.Consequently, the firm thinks the data addressed questions raised in an NEJM editorial about the drug. It keeps a $141 price target and Buy rating on the shares.
07:31 EDTCELGCelgene, Acceleron granted fast track designations for luspatercept
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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
06:13 EDTAZNAstraZeneca to invest $285M in new biologics manufacturing facility in Sweden
AstraZeneca announced that it plans to invest approximately $285M in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019. Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organisation. By locating the new manufacturing plant in Södertälje, the company will combine its expertise in biologics with the well-established culture of operational excellence that exists within the Sweden Operations unit. The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, Maryland, announced in November.
May 17, 2015
15:49 EDTAZNAstraZeneca reports Movantik shows 'similar' adverse event rate vs. placebo
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May 15, 2015
17:08 EDTTEVASoros Fund gives quarterly update on stakes
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09:31 EDTTEVA, AZN, PFEAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
08:12 EDTTEVATeva migraine treatment data positive, says Bernstein
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08:04 EDTTEVATeva to present new respiratory data at 2015 ATS conference
Teva Pharmaceutical Industries announced that three company-sponsored abstracts will be presented at the 2015 American Thoracic Society International Conference in Denver, Colorado on May 15-19.Data to be presented include a Phase III study examining the functionality, reliability, accuracy and overall patient satisfaction of ProAir RespiClick inhalation powder, which gained approval from the U.S. FDA in March 2015. ProAir RespiClick is now available by prescription and is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. Additional Phase III data to be presented include a late-breaking abstract highlighting an interim analysis of the long-term safety and efficacy of Teva’s investigational anti-IL-5 therapy, reslizumab, in patients with asthma and elevated blood eosinophils. A third abstract to be presented includes data from a dose-ranging study of fluticasone propionate multi-dose, dry-powder inhaler in adolescent and adult patients with asthma.
May 14, 2015
12:29 EDTPFEPfizer receives 'second request' from FTC regarding potential Hospira merger
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11:11 EDTCELGAnalysts divided on significance of Celgene blood cancer drug data
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09:22 EDTAZNLeerink 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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08:35 EDTTEVATeva says data present case for TEV-48125 progression to Phase III
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08:08 EDTPFEPfizer director Marc Tessier-Lavigne to step down from board
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07:44 EDTTEVAInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
19:17 EDTPFEHospira and FDA detect security vulnerabilities in infusion pumps
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17:42 EDTCELGCelgene announces over 55 blood, solid tumor cancer study presentations at ASCO
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17:24 EDTAZNAstraZeneca to update progress with immuno-oncology pipeline at ASCO
AstraZeneca and MedImmune, the company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology, or ASCO, Annual Meeting, May 29-June 2. 61 scientific abstracts will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.
17:19 EDTPFEPfizer, Merck KGaA to present data at ASCO for avelumab
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13:43 EDTPFEHospira shareholders approve merger with Pfizer
Hospira (HSP) announced that Hospira shareholders voted in favor of the proposal to adopt the merger agreement with Pfizer (PFE) at a special meeting of stockholders held May 13 in Denver, Colorado. On February 5, Hospira and Pfizer announced they had entered into a merger agreement under which Pfizer will acquire Hospira for $90 per share in cash for a total enterprise value of approximately $17B. The merger is subject to customary closing conditions, one of which was approval of the merger by Hospira's shareholders. Additional closing conditions to be met include obtaining regulatory approvals in several jurisdictions. Hospira and Pfizer continue to expect the merger to close in the second half of 2015.
08:02 EDTTEVAANI Pharmaceuticals acquires rights to testosterone gel 1%
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07:31 EDTPFEHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
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