Week of August 20, 2012: FDA Extends Pfizer's Action Date for Tofacitinib NDA; United Drug to Acquire Bilcare GCS; and More - Pharmaceutical Technology

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Week of August 20, 2012: FDA Extends Pfizer's Action Date for Tofacitinib NDA; United Drug to Acquire Bilcare GCS; and More

ePT--the Electronic Newsletter of Pharmaceutical Technology

Astellas Pharma Tech has announced plans to expand its facility at the Takahagi Technology Center (Japan) with a new GMP-compliant building with a total floor area of approximately 4170 m2 (44,885 ft2). The building will be equipped with flexible facilities capable of supporting a multiple lineup of manufacturing items and changes in volumes based on demand of investigational drug substance. The facility is estimated to cost JPY 4.2 billion ($53 million) and is expected to be completed in late July 2013. Read More

FDA has extended the action date by three months for Pfizer’s new drug application for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis. According to Pfizer, FDA determined that additional data analyses recently submitted by the company constitute a major amendment to the application and will require additional time to review. FDA has not asked that Pfizer complete any new studies. The FDA has provided an anticipated Prescription Drug User Fee Act date of Nov. 21, 2012. Read More

The biopharmaceutical company Regulus Therapeutics has entered into an alliance with AstraZeneca to discover, develop, and commercialize microRNA therapeutics for three exclusive targets that are currently in preclinical development. The targets are focused on cardiovascular and metabolic diseases and oncology. Under the agreement, AstraZeneca will make a $28-million payment which includes an equity investment and an upfront payment to Regulus. Read More

Additionally, Regulus has formed a collaboration with Biogen Idec to identify microRNAs as biomarkers for multiple sclerosis (MS). Under the transaction, Biogen Idec will make an investment in Regulus in addition to upfront and milestone payments. The key objective of the collaboration is to identify microRNA biomarkers in the blood of patients with MS. Read More

In other news, Regulus has filed a registration statement on Form S-1 with the US Securities and Exchange Commission relating to a proposed initial public offering of shares of its common stock. All shares of the common stock to be sold in the offering will be offered by Regulus. The number of shares to be offered and the price range for the offering have not yet been determined. Read More

United Drug, a provider of healthcare services, has agreed to acquire the clinical-services company Bilcare Global Clinical Supplies from Bilcare Limited for a total consideration of $61 million. The acquisition is expected to be completed on Aug. 31, 2012, and is subject to customary closing conditions. As part of the agreement, Bilcare Limited will retain its clinical supplies business in Asia. Read More

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More


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