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News Breaks
April 7, 2014
05:48 EDTAZN, MYGNMyriad Genetics submits premarket approval to FDA for BRACAnalysis
Myriad Genetics (MYGN) announced that it has submitted the first module of a premarket approval, or PMA, application to the FDA for the use of BRACAnalysis testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase, or PARP, inhibitor being developed by AstraZeneca (AZN).
News For MYGN;AZN From The Last 14 Days
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May 22, 2015
16:24 EDTAZNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
10:52 EDTAZNJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
12:40 EDTAZNHayman's Bass requests review of POZEN patents
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10:58 EDTAZNDeutsche Bank biotech analyst holds an analyst/industry conference call
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07:37 EDTAZNPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
11:51 EDTAZNExpress Scripts' Medco to pay $7.9M to resolve kickback allegations
Medco Health Solutions, a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company (ESRX), of Missouri, has agreed to pay the government $7.9M to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced. Medco provides pharmacy benefit management services to clients who receive subsidies under the Medicare Retiree Drug Subsidy program. The settlement resolves allegations that Medco solicited remuneration from AstraZeneca, a pharmaceutical manufacturer, in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on certain of Medco’s prescription drug lists known as formularies. The United States alleged that Medco received some or all of the remuneration from AstraZeneca in the form of reduced prices on the following AstraZeneca drugs: Prilosec, Toprol XL and Plendil. The United States contended that this kickback arrangement between Medco and AstraZeneca (AZN) violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program. In January 2015, the United States and AstraZeneca reached a $7.9M settlement to resolve kickback allegations arising out of the same conduct. This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, whose share of the settlement has not been determined. The settlement with Medco was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office of the District of Delaware and HHS-OIG.
May 19, 2015
15:05 EDTAZNArdelyx scheduled for end Phase 2 meeting with FDA scheduled in June
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May 18, 2015
06:13 EDTAZNAstraZeneca to invest $285M in new biologics manufacturing facility in Sweden
AstraZeneca announced that it plans to invest approximately $285M in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019. Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organisation. By locating the new manufacturing plant in Södertälje, the company will combine its expertise in biologics with the well-established culture of operational excellence that exists within the Sweden Operations unit. The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, Maryland, announced in November.
May 17, 2015
15:49 EDTAZNAstraZeneca reports Movantik shows 'similar' adverse event rate vs. placebo
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May 15, 2015
10:28 EDTMYGNMAC updates positive for NanoString, Myriad, Invitae, QIAGEN, says Leerink
Leerink said that coverage updates posted yesterday by Medicare Administrative Contractors were favorable for NanoString (NSTG), Myriad Genetics (MYGN), Invitae (NVTA) and QIAGEN (QGEN). The firm has Outperform ratings on NanoString and Invitae and Market Perform rating on the other two stocks listed.
09:31 EDTAZNAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
07:09 EDTMYGNMyriad Genetics presents clinical data for Prolaris test
Myriad Genetics presented clinical data for its Prolaris test at the 2015 American Urological Association, or AUA, Annual Meeting being held May 15-19 in New Orleans, La. The results highlighted and underscored the significant ability of the Prolaris test to help physicians improve care for men diagnosed with prostate cancer. In this pioneering study, Myriad presented important new clinical validation data that establishes an active surveillance, or AS, threshold for men with localized prostate cancer. Specifically, the AS threshold is a composite of the Prolaris test score and clinicopathologic features. In the validation data featured at AUA, the pre-defined AS threshold was evaluated in 765 conservatively managed men, and the clinical endpoint was 10-year risk of prostate cancer mortality. The results showed that at the AS threshold, the predicted 10-year survival rate of prostate cancer patients was 97%. Conversely, there was a three percent risk of 10-year, prostate-specific mortality. Importantly, however, there were no observed prostate cancer-specific deaths over 10 years among men whose scores fell below the AS threshold. Additionally, a separate analysis of 4,218 patients was performed to determine what percentage of patients who were clinically tested with Prolaris would be candidates for active surveillance based on the validated AS threshold. Of this commercial cohort, 36% qualified for active surveillance based on their clinical features alone. However, when the Prolaris test was added to the clinical risk assessment, 60% of these patients fell below the AS threshold, representing a significant increase in the total number of candidates who may be eligible for active surveillance.
May 14, 2015
09:22 EDTAZNLeerink pharma/biotech analysts hold an analyst/industry conference call
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05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
18:47 EDTMYGNMyriad Genetics to present data from 19 studies at 2015 ASCO meeting
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17:24 EDTAZNAstraZeneca to update progress with immuno-oncology pipeline at ASCO
AstraZeneca and MedImmune, the company’s global biologics research and development arm, will demonstrate rapid progress with their combination-focused oncology pipeline at the American Society of Clinical Oncology, or ASCO, Annual Meeting, May 29-June 2. 61 scientific abstracts will be presented at the meeting, reinforcing the significant progress in immuno-oncology through combination therapies and innovative companion diagnostics.
May 11, 2015
18:29 EDTMYGNAffordable Care Act guidance says insurers must cover BRCA1, BRCA2 testing
The United States Department of Labor issued updated Affordable Care Act guidance, which mandates that health insurers must cover testing for breast and ovarian cancer through analysis of the BRCA1 and BRCA2 genes. Myriad (MYGN), Foundation Medicine (FMI), and Genomic Health (GHDX) compete in the genetic testing space. Reference Link

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