Monday, November 30, 2015
Pfizer and Allergan have entered into a definitive merger agreement in a stock transaction currently valued at $363.63 per Allergan share, for a total enterprise value of about $160 billion, based on the closing price of Pfizer common stock of $32.18 on Nov. 20. The transaction represents more than a 30% premium based on Pfizer’s and Allergan’s unaffected share prices as of Oct. 28. Allergan shareholders will receive 11.3 shares of the combined company for each of their Allergan shares, and Pfizer stockholders will receive one share of the combined company for each of their Pfizer shares.
Merck, of Darmstadt, Germany, and Pfizer have announced that the FDA has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.
Pfizer has announced that PROFILE 1029, a phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet.
Thermo Fisher Scientific has entered into a long-term agreement with Novartis and Pfizer to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test that will serve as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) across multiple drug development programs.
The Pulse on Site Success by Jeffrey Adelglass
Collaboration from industry leaders has led to many steps in the evolution of clinical trials and it is becoming significantly apparent that common goals to streamline many of the processes involved in conducting clinical research studies are critical. Simplifying the experience for investigators to allow more time for clinical activities is an important step toward achieving this goal.
In a recent study, only two-thirds of clinical trials per drug that supported new drug approvals in 2012 were disclosed, falling below legal and ethical standards.
ICON, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has announced two new leadership appointments to its Asia Pacific operations. Mary Pan has been appointed vice president, Asia Pacific, where she will lead ICON’s continued growth and expansion in the region. Hiroshi Ichikawa has been appointed vice president and general manager of ICON’s operations in Japan.