HERTFORDSHIRE, England and PITTSBURGH , Aug. 12, 2015 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) today announced that Egan- Jones , one of the leading U.S. proxy advisory firms, has published a report recommending that Mylan shareholders support Mylan’s proposed acquisition of Perrigo Company plc (NYSE: PRGO; TASE). Glass Lewis, another leading U.S. proxy advisory firm, also published a report today recommending that Mylan shareholders support Mylan’s proposed acquisition of Perrigo .
In its recommendation Egan- Jones highlighted:
- The experience and prior success of Mylan’s management team in integrating large acquisitions into Mylan’s existing businesses,
- The shared culture between Mylan and Perrigo of integrity, respect and responsibility and that their common focus on innovation, reliability and customer service will be key contributors to a successful integration.
Mylan’s Executive Chairman Robert J. Coury commented, “We are pleased with Egan- Jones’ recommendation in favor of the Perrigo transaction as it serves as further affirmation of the sound strategic and financial rationale behind this combination. We are confident that this transaction will create compelling value for both Mylan and Perrigo shareholders and other stakeholders, and that our shareholders will vote in favor of this combination to create a one-of-a-kind global healthcare company.”
Mylan urges its shareholders to vote “FOR” the proposal to approve the Perrigo transaction described further in its definitive proxy statement that has been filed with the SEC . Mylan intends to launch its offer to acquire Perrigo’s ordinary shares after it receives the approval of Mylan shareholders at the upcoming extraordinary general meeting.
U.S. Food and Drug Administration Extends Action Date for Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Untreated Advanced Melanoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for Opdivo for the treatment of patients with previously untreated advanced melanoma. The company has taken the opportunity to submit additional data from the Opdivo clinical trial program to ensure the broadest data set, irrespective of BRAF status, was available for review. This submission constitutes a major amendment that will require additional time for review and the new FDA action date is November 27, 2015. read more
ImmunoCellular Therapeutics Reaches Agreement with FDA on Special Protocol Assessment (SPA) for ICT-107 Phase 3 Registrational Trial in Glioblastoma
LOS ANGELES, Aug. 13, 2015 /PRNewswire/ — ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma. The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of about 400 HLA-A2 positive subjects, which will be conducted at about 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have stated is the appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. Patient enrollment is anticipated to begin in the late third quarter or early fourth quarter of 2015. read more
Integra LifeSciences Completed Acquisition of TEI Biosciences and TEI Medical
Integra LifeSciences Holdings Corporation (NASDAQ:IART) announced that it has completed the acquisition of all of the outstanding shares of TEI Biosciences Inc. and TEI Medical Inc. (“TEI”). The acquisition of TEI complements and expands Integra’s reconstructive surgery and regenerative wound care product offerings. In addition, it will enhance shareholder value through the following strategic benefits: read more