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News Breaks
June 1, 2013
14:59 EDTMYGN, AZNAstraZeneca advances PARP inhibitor into Phase 3 trial with BRACAnalysis
Myriad Genetics (MYGN) announced that AstraZeneca (AZN) will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption, IDE, with the FDA for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States. While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic -- following review by FDA -- to help select patients who are likely to respond to poly ADP ribose polymerase, PARP, inhibitors, a novel, targeted class of promising cancer therapeutics. Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
News For MYGN;AZN From The Last 14 Days
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December 19, 2014
15:18 EDTAZNAstraZeneca confirms FDA approval of LYNPARZA
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12:12 EDTMYGN, AZNMyriad 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
10:17 EDTMYGNOn The Fly: Analyst Initiation Summary
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07:15 EDTMYGNMyriad Genetics initiated with a Market Perform at Wells Fargo
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December 17, 2014
10:21 EDTMYGNMyriad denied appeal to block competing breast cancer tests, Bloombeg reports
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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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12:54 EDTMYGNMyriad Genetics management to meet with William Blair
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
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
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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