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News Breaks
January 13, 2014
05:52 EDTAZN, BMYFDA approves Farxiga tablets for treatment of type 2 diabetes in adults
AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) announced the FDA approved Farxiga, a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga should not be used for the treatment of patients with type 1 diabetes or diabetic ketoacidosis. Farxiga is part of a newer class of medicines called sodium-glucose cotransporter 2 inhibitors, which remove glucose via the kidneys.
News For AZN;BMY From The Last 14 Days
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July 31, 2014
06:24 EDTAZNAstraZeneca offers 'no comment' on Pfizer, Reuters reports
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06:10 EDTBMYEli Lilly downgraded to Neutral from Buy at Citigroup
Citigroup downgraded Eli Lilly (LLY) to Neutral saying Alimta upside and the company's pipeline is largely priced into shares at current levels. Citi raised its price target for Lilly shares to $66 from $60 and said it prefers Bristol-Myers (BMY) and Pfizer (PFE) in the U.S.
July 30, 2014
06:10 EDTAZNAstraZeneca enters respiratory disease transaction with Almirall
AstraZeneca announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875M on completion, and up to $1.22B in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments. Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialization of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira, LAS40464, LAS100977 or abediterol, and multiple pre-clinical programs. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca. Almirall’s pipeline of respiratory assets and its device capabilities further strengthen AstraZeneca’s respiratory portfolio, which includes Symbicort and Pulmicort, as well as the company’s investigational medicines in development. The addition of aclidinium and the combination of aclidinium with formoterol, both in proprietary Genuair device, will allow AstraZeneca to offer patients a choice between dry powder inhaler and metered dose inhaler devices across a range of molecules and combinations. AstraZeneca and Almirall anticipate that, subject to local consultation and legislation, a significant number of employees dedicated to the respiratory business, including Almirall Sofotec employees, will transfer to AstraZeneca. The transaction is subject to certain competition law clearances as well as other customary terms and conditions. The companies anticipate the transaction will complete by the end of 2014.Reference Link
July 29, 2014
07:09 EDTBMYBristol-Myers, Pfizer granted EU approval for Eliquis for treatment of DVT, PE
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July 28, 2014
05:36 EDTAZNQIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
July 25, 2014
07:27 EDTBMYEMA recommends expanded indication for Baraclude
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06:00 EDTBMYBristol-Myers implied volatility of 17 at lower end of index mean range
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July 24, 2014
11:22 EDTBMYBristol-Myers says considering different sizes of deal opportunities
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10:57 EDTBMYBristol-Myers says M&A would have to be good strategic fit
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10:48 EDTBMYBristol-Myers says guidance assumes R&D credit will be extended
Says Reyataz seeing increased competitive pressure. Says business development a top priority for capital allocation. Comments made on the Q2 earnings conference call.
08:28 EDTBMYBristol-Myers management to meet with JPMorgan
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07:32 EDTBMYBristol-Myers reaffirms 2014 EPS outlook $1.70-$1.80, consensus $1.77
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07:31 EDTBMYBristol-Myers reports Q2 EPS 48c, consensus 44c
Reports Q2 revenue $ $3.89B, consensus $3.85B.
05:26 EDTBMYBristol-Myers, Ono Pharmaceutical announces strategic collaboration in Japan
Bristol-Myers Squibb and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo and Yervoy across a broad range of tumor types. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.
July 23, 2014
15:30 EDTBMYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Ford (F), consensus 36c; General Motors (GM), consensus 58c; Potash (POT), consensus 46c; Caterpillar (CAT), consensus $1.52; 3M (MMM), consensus $1.91; Union Pacific (UNP), consensus $1.43; Bristol-Myers Squibb (BMY), consensus 44c; Eli Lilly (LLY), consensus 65c; Celgene (CELG), consensus 89c; Precision Castparts (PCP), consensus $3.35; Raytheon (RTN), consensus $1.59; Noble Energy (NBL), consensus 79c; Hershey (HSY), consensus 76c; Southwest Airlines (LUV), consensus 61c; Boston Scientific (BSX), consensus 19c; JetBlue (JBLU), consensus 19c.
15:10 EDTBMYBristol-Myers technical comments before earnings
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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 21, 2014
06:43 EDTBMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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