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News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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May 28, 2015
06:11 EDTMYL, TEVATeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
19:14 EDTACTOn The Fly: After Hours Movers
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17:34 EDTACTActavis receives FDA approval for VIBERZI for treatment of IBS-D
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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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12:10 EDTTEVA, MYLTeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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08:32 EDTNVSNovartis entered into collaboration with Rani Therapeutics, Reuters says
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08:24 EDTTEVAFDA reports paragraph IV patent challenge received for Treanda
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07:33 EDTNVSIncyte says clinical portfolio to be featured in 23 abstract presentations
Incyte Corporation (INCY) announced that 23 abstracts detailing studies from its clinical development pipeline, including those conducted by Incyte, Novartis (NVS) and independent investigators, will be presented at the 2015 American Society of Clinical Oncology and European Hematology Association annual meetings. These conferences will take place from May 29th – June 2nd in Chicago, IL and June 11th – 14th in Vienna, Austria. “The abstracts to be presented at ASCO and EHA showcase the depth and breadth of our development pipeline in oncology, as well as the success of our collaboration with Novartis,” stated Rich Levy, MD, Incyte’s Chief Drug Development Officer. “Incyte is committed to translating R&D excellence into new medicines which can improve patients’ lives, and these data, including novel:novel combinations from within our portfolio, provide further evidence of our ongoing progress.”
05:22 EDTNVSNovartis to present data on 21 medicines, 11 investigational compounds at ASCO
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May 26, 2015
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
09:38 EDTBMYuniQure reports collaboration with Bristol-Myers closed, triggers $50M payment
uniQure (QURE) announced the closing of its strategic collaboration with Bristol-Myers Squibb (BMY) to develop gene therapies for cardiovascular disease. The transaction was previously announced on April 6. Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100M, including an initial upfront payment of $50M upon closing of the transaction, a $15M payment upon selection of three collaboration targets, in addition to S100A1, to be made within three months of closing, and an initial equity investment in uniQure representing 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or approximately $37M in total. The initial equity investment is expected to close on June 12. Bristol-Myers-Squibb will acquire an additional 5.0% ownership before December 31, at a 10% premium, and has been granted two warrants, each to acquire up to an additional 5% equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration. uniQure will also be eligible to receive research, development and regulatory milestone payments, including up to $254M for the lead S1A001 therapeutic and up to $217M for each other gene therapy product potentially developed under the collaboration. Additionally, uniQure is eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.
08:14 EDTJNJ, GSKBoston Biotech Conferences to hold a conference
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07:37 EDTBMYBristol-Myers opportunity in renal cell over $2B, says JPMorgan
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May 25, 2015
13:56 EDTMYLMylan responds to claims of EPS forecasting by Perrigo
Mylan (MYL) announced that it was asked by the Irish Takeover Panel to issue the following clarification and retraction in accordance with the Irish takeover rules, relating to its firm intention to make an offer to acquire Perrigo (PRGO). The clarification and retraction relates to certain forward-looking statements made by Mylan specifically during the "pendency of the offer" period concerning its long-stated target since 2012 of at least $6.00 in adjusted EPS by 2018. Subsequent to Mylan's May 5 earnings release, Perrigo submitted a complaint to the Irish Takeover Panel alleging that the reference to Mylan's $6.00 long-term target should be treated as a forward-looking profit forecast statement. Although Mylan's adjusted EPS goal has been a stated long-term target, and not a forecast of Mylan, at least during the offer period as it pertains to the Perrigo transaction, Mylan will no longer refer to that 2018 target or any other forward looking statements beyond 2015 that could constitute profit forecasts.
May 22, 2015
16:07 EDTACTActavis confirms court ruling requiring continued distribution of NAMENDA IR
Actavis confirmed that a panel of the U.S. Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the company to continue distribution of NAMENDA immediate-release tablets. Actavis noted that the company will continue to manage sales and R&D expenses to ensure that the Appeals court's decision will have minimal to no impact on its 2015 NAMENDA franchise contribution to earnings and longer term company earnings aspirations.
13:19 EDTACTNY AG says ruling on Actavis Alzheimer’s drug a victory for patients
New York Attorney General Eric Schneiderman, following a decision by the U.S. Court of Appeals for the Second Circuit to affirm the federal district court decision granting New York’s motion for a preliminary injunction against defendants Actavis and Forest Laboratories, stated: "Today’s appeals court decision is a sweeping victory for consumers and Alzheimer’s patients. Our lawsuit and the court’s injunction protect competition and prevent Actavis from coercing Alzheimer’s patients into taking drugs they do not want in order to charge them monopoly prices...My office will continue to protect New Yorkers from anticompetitive practices by drug manufacturers.”
11:26 EDTACTCourt rules Actavis can't pull Alzheimer's drug for pricer new one, Reuters says
A three-judge panel of a New York appeals court upheld a prior order requiring Actavis to keep the older version of its Alzheimer's drug, Namenda IR, on the market following the company's launch of a more expensive extended-release version, reported Reuters. Reference Link
11:23 EDTACTCourt rules Actavis can't pull Alzheimer's drug for pricer new one, Reuters says
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10:52 EDTNVS, ACT, BMY, JNJ, PFE, GSKJPMorgan 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.
07:44 EDTACTActavis trades at over 20% discount to Major Pharma, says JPMorgan
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07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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May 21, 2015
17:08 EDTJNJJohnson & Johnson Chief Accounting Officer Stephen Cosgrove to retire in October
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08:39 EDTNVSNovartis initiates Phase 1 PCA062, triggering milestone payment to ImmunoGen
In a regulatory filing, ImmunoGen disclosed Novartis (NVS) Institutes for BioMedical Research notified ImmunoGen (IMGN) that Novartis had initiated Phase I, first-in-human clinical testing of a product candidate, PCA062, utilizing antibody-drug conjugate technology. Pursuant to the license taken under our 2010 Multi-Target Agreement, this start of clinical testing triggers a $5M milestone payment to ImmunoGen.
07:37 EDTGSK, PFE, BMYPfizer replaces AbbVie as top global pharma pick at Jefferies
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05:19 EDTNVSNovartis Afinitor extended PFS in Phase III trial in GI or lung origin NET
Novartis announced that the Phase III study of Afinitor tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors, or NET, of gastrointestinal, or GI, or lung origin met its primary endpoint: significant extension of progression-free survival, or PFS, compared to placebo plus best supportive care. The RADIANT-4 study is part of one of the largest clinical trial programs in NET.
May 20, 2015
16:26 EDTJNJOn The Fly: Top stock stories for Wednesday
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11:36 EDTNVSNovartis says COPD programs met endpoints in Phase III study
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10:26 EDTJNJJanssen 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.
09:07 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.
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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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 EDTGSK, PFEDeutsche 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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07:21 EDTBMYUBS to hold a conference
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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.
09:25 EDTGSKGlaxoSmithKline asthma drug overused, risks underappreciated, ProPublica says
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08:57 EDTNVS, BMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMYGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
06:55 EDTPFE, NVS, GSKGenocea 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 EDTTEVA, MYLPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 18, 2015
12:29 EDTNVSCorium announces publication of data for needle-free transdermal flu vaccine
Corium International announced the publication of "promising" data on the use of its needle-free transdermal system to deliver influenza vaccine in the June 9 issue of Vaccine. The manuscript, entitled "Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," details results of a preclinical study conducted by Novartis Vaccines (NVS) and Corium. The results demonstrate the compatibility of Corium's MicroCor needle-free transdermal system with cell culture-derived influenza vaccines, and establish its potential as a next-generation vaccine delivery system, the company said.
12:07 EDTMYLPerrigo: there is price point where would engage with Mylan, Bloomberg reports
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11:21 EDTACTAckman sold out of Actavis stake after Q1 report, NY Post says
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08:01 EDTACTActavis launches Namzaric to treat moderate to severe Alzheimer's
Actavis announced that NAMZARIC, a once-daily, fixed-dose combination of memantine hydrochloride extended-release, and donepezil hydrochloride, is now available to patients and healthcare professionals across the United States. NAMZARIC was approved by the FDA in December for the treatment of moderate to severe Alzheimer's disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
07:38 EDTNVSNovartis outlook has improved, says Bernstein
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07:22 EDTACT, MYLUBS 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
07:15 EDTACTPhysician feedback on Actavis Eluxadoline positive, says RBC Capital
After conducting a survey, RBC Capital says that physician enthusiasm about Actavis' Eluxadoline is high ahead of its expected early 2016 launch. The firm thinks the drug could be an important P&L driver for the company and keeps a Top Pick rating on the shares.
06:58 EDTACT, PFEActavis 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 15, 2015
17:15 EDTACTPaulson & Co. gives quarterly update on stakes
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17:08 EDTTEVASoros Fund gives quarterly update on stakes
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17:03 EDTACTPershing Square gives quarterly update on stakes
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15:11 EDTGSKGlaxoSmithKline reports 16.12% stake in HTG Molecular
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14:51 EDTACT, MYLMylan ANDA for generic version of Lexapro approved by FDA
The ANDA from Mylan (MYL) for a generic version of Escitalopram Oxalate, which is sold under the trade name Lexapro by Actavis' (ACT) Forest Labs, was approved by the FDA on May 14, according to a post to the regulator's site. Reference Link
12:13 EDTACTThird 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).
09:31 EDTTEVA, PFE, MYL, NVS, GSKAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
09:29 EDTACTActavis: Warner Chilcott has held talks with DOJ over sales tactics, WSJ says
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08:30 EDTACTActavis price target raised to $360 from $325 at Susquehanna
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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.
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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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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11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts 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 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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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.
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