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News Breaks
June 4, 2014
10:14 EDTRHHBY, AZNRoche, AstraZeneca units collaborate on PD-L1 assay for immunotherapy trials
Ventana Medical Systems, a member of the Roche Group (RHHBY), and MedImmune, the biologics research and development arm of AstraZeneca (AZN), announced they are jointly developing a PD-L1 immunohistochemistry assay to enroll patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that will enroll only patients who express PD-L1 as determined by the VENTANA assay.
News For RHHBY;AZN From The Last 14 Days
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May 27, 2015
08:33 EDTRHHBYHalozyme and Ventana enter into global agreement to develop companion diagnostic
Halozyme (HALO) and Ventana Medical Systems, a member of the Roche (RHHBY), announced a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20. The Ventana assay will be used to identify high levels of hyaluronan. HA is a glycosaminoglycan that can accumulate around cancer cells. Halozyme has announced plans for rollout of a global phase 3 clinical study in 2016 targeting metastatic pancreatic cancer patients with high HA levels using its PEGPH20 in combination with ABRAXANE and gemcitabine. Under the agreement, Ventana will develop an in vitro diagnostic, under design control, using Halozyme's proprietary HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries. The financial terms of the agreement were not disclosed.
May 26, 2015
09:23 EDTAZNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up marginally after reporting third quarter results. ALSO HIGHER: Geeknet (GKNT), up 119.7% after being acquired by Hot Topic for $17.50 per share... IntelliPharmaCeutics (IPCI), up 16.8% after being granted fast track designation for Rexista Oxycodone by FDA... McDermott (MDR), up 9.2% after favorable mention in Barron's and after being awarded a project for 12 jackets offshore Saudi Arabia... Time Warner Cable (TWC), up 5.2% following announcement of merger with Charter (CHTR)... Charter is up fractionally. DOWN AFTER EARNINGS: Sky-mobi (MOBI), down 7.9%. ALSO LOWER: Etsy (ETSY), down 5.7% following a Wall Street Journal report that Amazon.com (AMZN) is targeting Etsy with an artisan goods marketplace... First Solar (FSLR), down 4.1% after being downgraded to Underperform from Sector Perform at RBC Capital... AstraZeneca (AZN), down 1.9% after Amgen (AMGN) ends participation in co-development and commercialization of brodalumab... Amgen is down 1.5%.
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 EDTRHHBY, AZNJPMorgan 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 EDTRHHBY, AZNPfizer 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
16:07 EDTRHHBYIllumina files new patent infringement suit against Roche unit
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10:01 EDTRHHBYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: A10 Networks (ATEN) upgraded to Overweight from Sector Weight at Pacific Crest... Cal-Maine Foods (CALM) upgraded to Overweight from Equal Weight at Stephens... ChemoCentryx (CCXI) upgraded to Overweight from Neutral at JPMorgan... Cheniere Energy Partners LP (CQP) upgraded to Buy from Neutral at Goldman... Chicago Bridge & Iron (CBI) upgraded to Neutral from Sell at Goldman... Continental Resources (CLR) upgraded to Buy from Neutral at Goldman... Ctrip.com (CTRP) upgraded to Overweight from Neutral at JPMorgan... Emerge Energy (EMES) upgraded to Buy from Neutral at Goldman... FEMSA (FMX) upgraded to Overweight from Equal Weight at Morgan Stanley... GoPro (GPRO) upgraded to Perform from Underperform at Oppenheimer... Holly Energy (HEP) upgraded to Buy from Neutral at Goldman... JP Energy (JPEP) upgraded on better visibility on volumes at RBC Capital... Laredo Petroleum (LPI) upgraded to Neutral from Sell at Goldman... Malvern Bancorp (MLVF) upgraded to Outperform from Market Perform at Keefe Bruyette... Newfield Exploration (NFX) upgraded to Buy from Neutral at Goldman... Norsk Hydro (NHYDY) upgraded to Overweight from Neutral at JPMorgan... Owens-Illinois (OI) upgraded to Neutral from Underperform at BofA/Merrill... Penn National (PENN) upgraded to Buy from Neutral at Goldman... Roche (RHHBY) upgraded to Buy from Neutral at UBS... Schnitzer Steel (SCHN) upgraded on stabilizing headwinds at KeyBanc... Seventy Seven Energy (SSE) upgraded to Buy from Hold at Jefferies... Toll Brothers (TOL) upgraded to Neutral from Underperform at Sterne Agee CRT... United Therapeutics (UTHR) upgraded to Buy from Neutral at BTIG... Volvo (VOLVY) upgraded to Neutral from Underweight at JPMorgan... Zayo Group (ZAYO) upgraded to Buy from Neutral at Goldman.
09:23 EDTRHHBYRoche upgraded to Buy from Neutral at UBS
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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
09:31 EDTAZNAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 14, 2015
09:22 EDTRHHBY, AZNLeerink 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
18:12 EDTRHHBYGenentech alectinib shrank tumors in about half of ALK-positive NSCLC patients
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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.
17:04 EDTRHHBYGenentech announces interim results from POPLAR study
Genentech, a member of the Roche Group announced interim results from a global, randomized Phase II study, POPLAR, in people with previously treated non-small cell lung cancer, NSCLC. The study showed the investigational cancer immunotherapy MPDL3280A doubled the likelihood of survival; hazard ratio [HR]=0.47) in people whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in people who had medium and high or any level of PD-L1 expression, as characterized by a test being developed by Roche. MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for MPDL3280A in NSCLC. Updated results will be presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology. “In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines.”

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