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August 22, 2014
10:07 EDTEXAS, ORPH, AZNOptions with increasing implied volatility: ORPH EXAS AZN
News For ORPH;EXAS;AZN From The Last 14 Days
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December 19, 2014
15:48 EDTEXASExact Sciences CMS lobbying may take several months, says Maxim
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15:33 EDTEXASExact Sciences says working with CMS to clarify Cologuard reimbursement
Exact Sciences said the reimbursement amount published today for Cologuard in the 2015 Clinical Diagnostic Laboratory Fee Schedule is inconsistent with what the Centers for Medicare and Medicaid Services, or CMS, publicly communicated on November 25 when CMS issued a final payment decision for Cologuard using the crosswalk methodology to CPT codes 81315, 81275, and 82274. Utilizing the crosswalk methodology based on the updated 2015 fee schedule the total for these codes is $500.76. Exact Sciences is working with CMS to clarify and will communicate more information once it becomes available. CMS has a process to establish payment rates for clinical laboratory tests and Exact Sciences followed that process. On July 11, Exact Sciences proposed a crosswalk methodology for Cologuard to CPT codes, 82274, 81275 and 81315. CMS agreed with that crosswalk methodology when they published their preliminary payment recommendation on October 11. CMS received public comments on that recommendation and on November 25 published their final recommendation which affirmed the crosswalk methodology, the company noted.
15:18 EDTAZNAstraZeneca confirms FDA approval of LYNPARZA
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15:06 EDTEXASExact Sciences CMS confusion seen as clerical error, says Canaccord
Canaccord said management of Exact Sciences are attributing confusion around the code used for reimbursement of its Cologuard test to a clerical error at CMS and that the company has reached out to resolve the issue. A national diagnostics expert also said the CMS update is likely a clerical error, the firm noted. Canaccord has a Buy rating and $30 price target on Exact Sciences.
12:58 EDTEXASExact Sciences slips amid questions on Cologuard reimbursement
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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 16, 2014
09:16 EDTEXASOn The Fly: Pre-market Movers
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09:05 EDTEXASExact Sciences 4M share Spot Secondary priced at $25.75
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December 15, 2014
16:15 EDTEXASExact Sciences files automatic mixed securities shelf
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16:09 EDTEXASExact Sciences files to sell 4M shares of common stock
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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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14:43 EDTEXASExact Sciences 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.
December 5, 2014
09:49 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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