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News Breaks
April 19, 2014
13:25 EDTAZN, AZN, AZN, BMY, BMY, BMY, MRK, MRK, MRK, RHHBY, RHHBY, RHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
Major Pharmaceuticals Analyst Fernandez and Biotech Analyst Liang discuss new developments in bladder cancer including design and registrational potential of Roche/ Genentech Ph II trial in metastatic bladder cancer and rationale for use of immunotherapy and expectations for PD1/ PDL1 agents on an Analyst/Industry conference call to be held on April 22 at 2 pm.
News For AZN;BMY;MRK;RHHBY From The Last 14 Days
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September 17, 2014
11:00 EDTRHHBYRoche CEO rules out megadeals, focused on bolt-on acquisitions, WSJ says
Roche CEO Severin Schwan said the company won't change its acquisition strategy following the recent deals made or abandoned in the pharmaceutical sector, reports the Wall Street Journal. In an interview with WSJ, Shwan said, "We have been very consistent in our approach to M&A." Regarding transformational deal-making, he said, "We have no intention to do that, whatever happens in the industry." Reference Link
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
07:43 EDTAZN, BMY, RHHBYBofA/Merrill to hold a conference
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September 16, 2014
14:33 EDTAZNNektar price target raised to $20 from $18 at Brean Capital
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12:37 EDTAZNNektar reports FDA approval of MOVANTIK for treatment of OIC
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the FDA approved MOVANTIK tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, or OIC, in adult patients with chronic, non-cancer pain. In line with the recommendation from the FDA Anesthetic and Analgesic Drug Products Advisory Committee that took place in June, AstraZeneca has agreed to conduct a post-marketing, observational epidemiologic cardiovascular safety study for MOVANTIK. MOVANTIK is expected to be available to patients in the first half of 2015. MOVANTIK is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the New Drug Application, the FDA evaluated the abuse potential of MOVANTIK and the approved labelling indicates that MOVANTIK has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of MOVANTIK to the U.S. Drug Enforcement Administration, or DEA, in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request.
11:51 EDTAZNOECD looks to close tax loopholes with new proposals
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10:19 EDTAZNFDA approves Movantik with requirement for cardiovascular risk study
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08:00 EDTAZNFDA PDUFA Date for Nektar and AstraZeneca''s Movantik is September 16, 2014
07:31 EDTRHHBY, MRK, AZNEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
07:02 EDTAZNEli Lilly and AstraZeneca to co-develop and commercialize AZD3293
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06:27 EDTAZNAstraZeneca, Eli Lilly to jointly develop, commercialize AZD3293
AstraZeneca (AZN) and Eli Lilly (LLY) announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293 has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50M in the 1H15. The companies will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of AZD3293. The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca's 2014 Core Earnings per Share.
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
07:27 EDTAZNPfizer acquisition could drive shares higher, says JPMorgan
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September 12, 2014
10:32 EDTAZNPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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15:21 EDTAZNAstraZeneca has a conference call hosted by JPMorgan
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13:04 EDTRHHBYRoche unit receives orphan status for lung cancer mutation drug
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