Allergan (AGN) Legal Move 'Extremely Important for Industry' - Evercore ISI Raffat

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Eli Lilly & Co. (LLY) Presents Clinical Evidence for CYRAMZA (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer

September 11, 2017 5:57 AM EDT

At the European Society for Medical Oncology (ESMO) 2017 Congress today, Phase 3 RANGE data from Eli Lilly and Company (NYSE: LLY) were presented in the Presidential Symposium (abstract#: LBA4_PR). These are the first detailed results from the global, randomized, double-blinded, placebo-controlled RANGE study of CYRAMZA® (ramucirumab), in combination with docetaxel, in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The data showed a statistically significant improvement in progression-free survival (PFS) in patients treated with ramucirumab plus docetaxel when compared to those who received placebo plus docetaxel, with a... More

Pfizer (PFE) Reports Positive Pivotal Data for PF-05280014, an Investigational Biosimilar to Herceptin (trastuzumab) at ESMO 2017

September 11, 2017 5:56 AM EDT

Pfizer Inc. (NYSE: PFE) today announced positive findings from REFLECTIONS B327-02 (n=707), a pivotal Phase 3 randomized, double-blind comparative safety and efficacy study of the companys investigational trastuzumab biosimilar (PF-05280014) versus Herceptin®1 (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid. Positive data from a supplemental study, REFLECTIONS B327-04 (n=226), were also presented at the meeting. PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin.

Biosimilars are poised to revolutionize the oncology treatment landscape by expanding patient access to high quality and effective therapies, said Dr. Mark... More

Amgen (AMGN) & Allergen (AGN) Report Phase 3 Data On Biosimilar Trastuzumab Candidate ABP 980

September 11, 2017 5:46 AM EDT

Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin® (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Results from the neoadjuvant efficacy phase of the study, including pathologic complete response assessed both by local investigators and also by independent pathology review, were presented today during a poster discussion at the European Society for Medical Oncology (ESMO) 2017 Congress. Efficacy, safety and... More

Allergen (AGN): 'Innovative and Unexpected Positive Move' - Wells Fargo

September 8, 2017 2:06 PM EDT

Wells Fargo analyst David Maris weighed in on Allergen (NYSE: AGN) after what they view as an "innovative and unexpected positive move" that should eliminate the threat of the inter partes review (IPR) on Restasis.

To wit... "Under an agreement with the Saint... More

Allergan (AGN) Resumes Trading, Shares Edge Higher

September 8, 2017 12:47 PM EDT

Allergan (NYSE: AGN) Resumes Trading, Shares Edge Higher

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Allergan (AGN) and Saint Regis Mohawk Tribe Announce Agreement on RESTASIS Patents

September 8, 2017 12:36 PM EDT

Allergan plc (NYSE: AGN) and the Saint Regis Mohawk Tribe today announced that the Tribe now owns all Orange Book-listed patents for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, and that Allergan has been granted exclusive licenses in the patents related to the product. The Tribe, a recognized sovereign tribal government, is filing a motion to dismiss the ongoing inter partes review (IPR) of the RESTASIS® patents based on their sovereign immunity from IPR challenges. The agreement with the Tribe has no impact on the pending abbreviated new drug application (ANDA) patent litigations... More