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Stock Market & Financial Investment News

News Breaks
March 7, 2014
12:25 EDTBIIB, BIIB, BAX, BAX, ALNY, ALNY, NKTR, NKTR, SGMO, SGMO, SHPG, SHPG, CSL, CSL, PFE, PFE, NVO, NVOPiper Jaffray's healthcare analysts hold an analyst/industry conference call
Analysts, along with Dr. Powell, Director of the Hemophilia Treatment Center at UC Davis Health System, review the current treatment paradigm for Hemophilia A and Hemophilia B on an Analyst/Industry conference call to be held on March 7 at 1 pm.
News For BIIB;BAX;ALNY;NKTR;SGMO;SHPG;CSL;PFE;NVO From The Last 14 Days
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April 9, 2015
09:51 EDTPFEPerrigo did not expect Mylan takeover letter, CNBC's Faber reports
Perrigo (PRGO) did not expect the takeover letter it received from Mylan (MYL), CNBC's David Faber reports, citing sources. Perrigo will take its time in deciding what its next steps are, Faber added. Shares of Mylan are up 3% in early trading, which is being attributed, at least in part, to speculation the company could be a takeover target itself. Analysts this morning mentioned Teva (TEVA) as a potential acquirer of Mylan. Chatter this morning has Pfizer (PFE) also potentially interested in the EpiPen maker
09:25 EDTPFE, BIIBPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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07:27 EDTBIIBBiogen PML death case previously reported, says Deutsche Bank
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07:23 EDTBIIBDoctors report case of fatal PML in patient treated with Tecfidera to NEJM
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05:27 EDTSHPGShire reports results from three placebo-controlled Phase 2 studies of SHP625
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April 8, 2015
07:24 EDTBIIBNeurotechnology Industry Organization to hold a conference
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06:57 EDTALNYAlnylam added to short-term buy list at Deutsche Bank
April 7, 2015
15:44 EDTNVONovo Nordisk announces FDA accepts Tresiba, Ryzodeg resubmissions for review
Novo Nordisk announced that the U.S. FDA has accepted for review the Class II Resubmissions for Tresiba and Ryzodeg. To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review, on matters related to the interim analysis. As previously communicated, the result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate derived from the interim analysis is thus only an indication of the final trial results. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.
11:10 EDTNKTRNektar management to meet with Jefferies
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10:10 EDTSHPGJazz patent on Xyrem latest to be challenged by Kyle Bass
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08:10 EDTSHPGShire shares pricing in worst case scenario for patents, says Citigroup
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08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizerís anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:31 EDTBIIBBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTBIIB, PFEEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:13 EDTSHPGShire patent challenges only modest threat, says Jefferies
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07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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05:23 EDTSHPGShire reaches agreement with FDA on clear regulatory path for SHP465
Shire announces that it has reached an agreement with the FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder, or ADHD, in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by 2Q17 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.
April 6, 2015
10:37 EDTPFETargacept says Pfizer terminates research & license agreement with Catalyst
In a regulatory filing from earlier, Targacept (TRGT) said: "As previously reported, on March 5, Targacept, Talos Merger Sub, a Delaware corporation and a wholly owned subsidiary of Targacept and Catalyst Biosciences, entered into an Agreement and Plan of Merger, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Catalyst, with Catalyst becoming a wholly owned subsidiary of Targacept and the surviving corporation of the merger. On April 1, Catalyst notified Targacept that Pfizer (PFE) would be exercising its right to terminate in its entirety the June 29, 2009, research and license agreement between Catalyst and Wyeth, which governs the development and commercialization of Catalystís leading human Factor VIIa product candidate for the treatment of hemophilia and surgical bleeding indications. On April 2, Pfizer provided Catalyst with its formal written notice of termination of the research and license agreement. Upon the June 1, effective date of the termination, the license and certain rights under the research and license agreement will terminate and revert to Catalyst. Catalyst has informed Targacept that Pfizer is committed to an orderly transfer of data, regulatory documentation and related technology under the agreement to Catalyst to enable Catalyst to continue the clinical development of this product candidate. Targacept is currently reviewing the implications of this event on the proposed Merger. In morning trading shares of Targacept are down almost 12% to $2.51.
09:09 EDTSHPGShire says will defend patents 'vigorously' after Hayman petitions
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