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June 3, 2014
11:00 EDTAZNAstraZeneca unit says MEDI4736 studies showed clinical activity
MedImmune, the biologics research and development arm of AstraZeneca, presented results from its novel investigational immunotherapy portfolio, focusing on MEDI4736, at the American Society of Clinical Oncology meeting. "Overall, studies demonstrated durable and tolerability for MEDI4736 across a range of tumor types," the company said. In a Phase I dose-escalation study of MEDI4736 in 27 patients with advanced solid tumors, reduction of tumor burden was seen at multiple dose levels in as early as six weeks. Clinical activity was maintained for at least one year, with 19% of patients achieving a partial response and 39% of patients achieving disease control. "There was a very low frequency of drug-related serious adverse events, and no dose-limiting toxicities were observed," Medimmune added.
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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 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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07:28 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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