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News Breaks
January 22, 2014
06:25 EDTAZN, BMYAstraZeneca, Bristol-Myers say Xigduo approved in the EU for type 2 diabetes
AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) announced that Xigduo has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union. Xigduo combines dapagliflozin, a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin. Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.
News For AZN;BMY From The Last 14 Days
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February 4, 2016
06:27 EDTAZNAstraZeneca sees FY16 core EPS down low to mid single-digit percentage
Sees FY16 total revenue down low to mid single-digit percentage. The company said the guidance "incorporates the dilutive effects arising from the Acerta Pharma and ZS Pharma transactions announced in 2015." It added, "The guidance also assumes the loss of exclusivity for Crestor in the US from May 2016. Externalisation Revenue is expected to be ahead of that in FY 2015, including an increasing element of recurring income arising from prior agreements. This is in line with the Company's long-term business model." AstraZeneca said core R&D costs are expected to be at a similar level to FY15. The company said it is also committed to materially reducing Core SG&A costs in FY16.
06:26 EDTAZNAstraZeneca reports Q4 core EPS 94c, consensus 94c
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February 3, 2016
14:48 EDTAZNNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include Philip Morris (PM), consensus 81c... AstraZeneca (AZN), consensus 88c... Occidental Petroleum (OXY), consensus (12c)... ConocoPhillips (COP), consensus (65c)... Cigna (CI), consensus $1.80... Intercontinental Exchange (ICE), consensus $3.01... Boston Scientific (BSX), consensus 25c... Charter Communications (CHTR), consensus (12c)... Ralph Lauren (RL), consensus $2.13... Dunkin' Brands (DNKN), consensus 50c... GrubHub (GRUB), consensus 14c... Level 3 (LVLT), consensus 53c... AmerisourceBergen (ABC), consensus $1.25... Cummins (CMI), consensus $2.11.
11:25 EDTAZNAstraZeneca management to meet with Jefferies
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February 2, 2016
13:35 EDTBMYEarnings Watch: Merck down over 5% since last earnings report
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09:46 EDTBMYIntercept rumored to draw interest from many suitors, Daily Mail says
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08:53 EDTBMYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
06:58 EDTBMYPortola Pharma licensed right to andexanet alfa to Bristol-Myers and Pfizer
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06:57 EDTBMYBristol-Myers and Pfizer sign collaboration with Portola Pharmaceuticals
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January 29, 2016
07:49 EDTBMYBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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07:11 EDTAZNAllergan enters into global agreement with AstraZeneca for ATM-AVI
Allergan announced that it has entered into a global agreement with AstraZeneca to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam. Together, the two companies will evaluate the combination to treat serious infections caused by metallo betalactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae, or CRE, for which there are currently very limited treatments, thus presenting a new treatment option for patients with MBL-producing pathogens. Under the terms of the agreement, Allergan will maintain commercialization rights in the U.S. and Canada and AstraZeneca will maintain commercialization rights in all other countries.
January 28, 2016
12:42 EDTBMYBristol-Myers says EU approves Daklinza for treatment of chronic hepatitis C
Bristol-Myers Squibb announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis. The new indications are based on data from the ALLY-1 clinical trial and ALLY-2 clinical trial. The recommended treatment regimens and durations are as follows:
09:27 EDTBMYBristol-Myers reports Q4 US revenue $2.3B
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09:27 EDTBMYBristol-Myers sees FY16 non-GAAP EPS $2.30-$2.40, consensus $2.29
Sees FY16 revenue up in mid-single digit range, consensus $17.4B. Sees FY16 gross margin as percentage of revenue ot be approximately 75%-76%. Sees FY16 marketing, sales and administrative expenses decreasing in mid-single digit range. Sees FY16 R&D expenses increasing in high-single digit range. Sees FY16 effective tax rate between 21%-22%.
09:25 EDTBMYBristol-Myers reports Q4 non-GAAP EPS 38c, consensus 28c
Reports Q4 revenue $4.29B, consensus $4.15B.
07:11 EDTBMYBristol-Myers: DMC concluded that CheckMate Phase 3 study met primary endpoint
07:00 EDTBMYBristol-Myers says CheckMate-141 Opdivo Phase 3 trial stopped early
Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer." CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
January 27, 2016
14:34 EDTBMYNotable companies reporting before tomorrow's open
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14:17 EDTBMYBristol-Myers technical comments before earnings news
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13:55 EDTBMYBristol-Myers volatility elevated into Q4 and outlook
Bristol-Myers Black & Decker January weekly call option implied volatility is at 49, February is at 30; compared to its 52-week range of 18 to 43, suggesting large near term price movement into the expected release of Q4 results on January 28.
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