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May 9, 2014
16:02 EDTAZN, AMGNAmgen, AstraZeneca reports brodalumab study met primary, secondary endpoints
Amgen (AMGN) and AstraZeneca (AZN) announced that the Phase 3 AMAGINE-1 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. Primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index, and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment.
News For AMGN;AZN From The Last 14 Days
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May 21, 2015
14:48 EDTAMGNRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
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.
09:52 EDTAMGNAlliance for Health Reform holds a webcast on biosimilars
"Biosimilars in the U.S.: Current & Emerging Issues" provides essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future. Speakers include Chief Scientific Officer Ramachandra from Hospira, Executive Director Eich from Amgen on the briefing being held on May 20 at 12 pm. Webcast Link
May 19, 2015
15:05 EDTAZNArdelyx scheduled for end Phase 2 meeting with FDA scheduled in June
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08:57 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:51 EDTAMGNFDA PDUFA Date for Amgen's Blinatumomab is May 19, 2015
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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
12:13 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Yum! Brands (YUM), NXP Semiconductors (NXPI), FedEx (FDX), McKesson (MCK), and J M Smucker (SJM). INCREASED STAKES: Actavis (ACT), Roper Technologies (ROP), Delta Air Lines (DAL), and FleetCor Technologies (FLT). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Phillips 66 (PSX), eBay (EBAY), and Anheuser Busch Inbev SA (BUD). LIQUIDATED STAKES: Alibaba Group (BABA), Citigroup (C), EMC Corporation (EMC), Anglo American (AAL), and Williams Companies (WMB).
09:31 EDTAZNAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
05:32 EDTAMGNAmgen presents first Phase 2 data for AMG 334
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May 14, 2015
10:41 EDTAMGNAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTAZNLeerink pharma/biotech analysts hold an analyst/industry conference call
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07:44 EDTAMGNInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
05:52 EDTAZNMizuho expects CAR T stocks to be volatile after ASCO abstract
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May 13, 2015
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.
17:17 EDTAMGNAmgen to present key results in solid tumor, hematologic malignancy treatments
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