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News Breaks
April 4, 2014
06:49 EDTCELG, MYLMylan sues Celgene for blocking Thalomid, Revlimid generics, Reuters says
Mylan (MYL) sued Celgene (CELG) to stop the latter's effort to keep generic versions of Revlimid and Thalomid off the market, according to Reuters, citing comments from Mylan. Combined, both drugs generate $4.5B of annual sales. Reference Link
News For MYL;CELG From The Last 14 Days
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December 10, 2014
07:38 EDTMYLMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
14:10 EDTCELGCelgene ISTODAX combination demonstrates complete response in 51% of patients
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08:34 EDTCELGCelgene price target raised to $130 from $102 at Argus
Argus hiked its price target on Celgene as the firm thinks the company posted solid Q3 results, while it is continuing to make progress in its pipeline. Argus keeps a Buy rating on the shares.
08:28 EDTCELGCelgene price target raised to $130 from $112 at UBS
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07:44 EDTCELGAmerican Association for Cancer Research to hold a symposium
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05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
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05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
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December 8, 2014
14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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11:30 EDTMYLLeerink generics pharmaceutical analyst holds analyst/industry conference call
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07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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December 7, 2014
16:40 EDTCELGAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:10 EDTCELGAmerican Society of Hematology to hold a meeting
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13:16 EDTCELGCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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December 6, 2014
09:28 EDTCELGCelgene to hold an analyst and investor event
Analyst and Investor Event being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 7 at 11 pm. Webcast Link
December 5, 2014
10:05 EDTMYLBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
December 4, 2014
10:03 EDTMYLMylan receives tentative FDA approval for abacavir/lamivudine NDAs
Mylan announced that its subsidiary Mylan Laboratories has received tentative approval from the FDA for its New Drug Applications for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored, Mylan said. The FDA's tentative approval through the President's Emergency Plan for AIDS Relief program means the formulations meet all of the agency's quality, safety and efficacy standards, it stated. The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan's products are expected to be eligible for purchase in early 2015.
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