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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.
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July 22, 2014
05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
July 16, 2014
10:36 EDTAZNTreasury calls on Congress to halt inversion deals
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08:01 EDTAZNAlexion names former AstraZeneca CEO David Brennan to board
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07:59 EDTAZNTreasury Secretary urges Congress to take action on tax inversions
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July 8, 2014
07:17 EDTAZNLeerink raises immuno-oncology market forecast to $36B
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