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News Breaks
February 5, 2014
06:44 EDTMRK, AMGN, INCY, PFEMerck signs three clinical collaboration agreements to evaluate MK-3475
Merck (MRK) announced it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen (AMGN), Incyte (INCY) and Pfizer (PFE) to evaluate novel combination regimens with MK-3475, Merck's investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed.
News For MRK;AMGN;INCY;PFE From The Last 14 Days
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October 21, 2014
14:25 EDTAMGNAmgen urged by Third Point to split up
In its Q3 investor letter, Dan Loeb's Third Point said it is now one of Amgen's (AMGN) largest shareholders. Amgen's first steps to target its "inflated cost structure" should be applauded, but Third Point believes "much more can and should be done," the firm wrote. Immediate action Amgen can take to create shareholder value include focusing its R&D efforts, providing long-term margin guidance demonstrating a commitment to reducing costs and creating clarity on additional shareholder returns, Third Point also said. Additionally, Third Point said it believes that Amgen could benefit from a separation and should seriously consider breaking up into a "MatureCo" and a "GrowthCo." Shares of Amgen are up 4% to $143.12 in afternoon trading following the circulation of Third Point's Q3 investor letter.
14:09 EDTAMGNThird Point discloses new positions in eBay, Alibaba, exit from Sony
In its Q3 investor letter, Third Point says it established a "significant" position in eBay (EBAY). Dan Loeb's hedge fund also revealed it has established a significant direct investment in Alibaba (BABA) shares now that the company is public. Third Point also said it is now one of Amgen's (AMGN) largest shareholders. During the quarter, Third Point exited its position in Sony (SNE) and reduced or exited other positions, including AIG (AIG), Hertz (HTZ) and Softbank (SFTBF), the firm stated in its letter. PRICE ACTION: Following the disclosures in the Third Point letter, Amgen is up 4%, eBay is up 2.3% and Alibaba is up 3.8%, while Sony shares trading in New York are down nearly 1%.
13:56 EDTAMGNDan Loeb discloses position in Amgen at Robin Hood Conference, CNBC reports
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07:54 EDTINCYLeerink a buyer of Alkermes, ImmunoGen, Incyte
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07:15 EDTPFE, AMGNFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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October 20, 2014
08:06 EDTMRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:19 EDTMRK, AMGNIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTMRK, PFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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09:06 EDTAMGNAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
08:01 EDTINCYIncyte names Gryska CFO to succeed Hastings
Incyte announced the appointment of David Gryska as Executive Vice President and CFO, effective October 31. Gryska will succeed David Hastings, who has served as Incyte’s Executive Vice President and CFO since October 2003. Hastings, who is leaving the company to pursue other opportunities, will remain with Incyte through the end of November and will work closely with Gryska to ensure a seamless transition.
07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
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