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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 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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July 17, 2014
08:08 EDTBMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTAZNTreasury calls on Congress to halt inversion deals
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08:01 EDTAZNAlexion names former AstraZeneca CEO David Brennan to board
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07:59 EDTAZNTreasury Secretary urges Congress to take action on tax inversions
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06:26 EDTBMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTBMYPerrigo retreats after analyst sees limited potential buyers
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07:35 EDTBMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
July 8, 2014
07:20 EDTBMYBristol-Myers price target lowered to $55 from $62 at Leerink
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07:17 EDTBMY, AZNLeerink raises immuno-oncology market forecast to $36B
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