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News Breaks
February 14, 2013
12:15 EDTAZN, MYLAstraZeneca wins appeal to block generic Seroquel XR from Mylan, others
After a New Jersey district court ruled last March that AstraZeneca's (AZN) formulation patent protecting Seroquel XR extended release tablets was valid, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's ruling today. The lower court had also ruled that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals and Mylan Pharmaceuticals (MYL) have infringed the Seroquel XR formulation patent, which expires in 2017. Reference Link
News For AZN;MYL From The Last 14 Days
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December 22, 2014
07:41 EDTMYLMylan launches generic version of Vivelle-DOT
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06:44 EDTAZNPfizer 'unlikely' to make fresh bid for AstraZeneca, Reuters reports
AstraZeneca (AZN) CEO Pascal Soriot told Swedish business daily Dagens Industri that Pfizer (PFE) is "unlikely" to make a fresh bid for the company, Reuters reports. Reference Link
December 19, 2014
15:18 EDTAZNAstraZeneca confirms FDA approval of LYNPARZA
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12:12 EDTAZNMyriad Genetics receives FDA approval of BRACAnalysis CDx
Myriad Genetics (MYGN) announced that it has received approval from the U.S. FDA for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's (AZN) drug Lynparza. Lynparza is the first poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor. BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad's commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.
11:45 EDTAZNFDA approves Lynparza to treat advanced ovarian cancer
The U.S. FDA granted accelerated approval to Lynparza, a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. Reference Link
December 18, 2014
10:41 EDTMYLHigh option volume stocks
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December 16, 2014
09:52 EDTMYLFDA ruling on generic Celebrex reversed by appeals court
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December 15, 2014
07:33 EDTAZNAdvaxis announces FDA acceptance of INDA to commence clinical trials of ADXS-HPV
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December 11, 2014
16:03 EDTAZNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
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
09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZNMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTAZNAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
11:30 EDTMYLLeerink generics pharmaceutical analyst holds analyst/industry conference call
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07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.

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