PharmAsia News

Astellas Advances Antibody R&D Agenda With Agensys Purchase Worth Up To $537 Million

Astellas has agreed to buy Agensys, a privately held U.S. biotech with a portfolio of novel cancer targets and monoclonal antibodies to match, in a deal worth up to $537 million, the firms announced Nov. 27.

Insider Analysis: Can Outsourced Clinical Trials Also Be The Best?

The Potential To Harmonize Best Practices in China, India and Globally (Part 2 of 2)

By: Leslie A. Platt, Jason Schwartz, Reza Zarghamee, and Vladimir Chechik, Pillsbury Winthrop Shaw Pittman LLP, Washington, D.C.

The first part of this two-part column explored the remarkable potential for outsourcing clinical trials to China, India and other developing nations, as well as the challenges that worldwide governments face when establishing and enforcing best practices for such outsourced clinical research. This second part focuses on potential methods for benchmarking outsourced clinical research to internationally-recognized performance standards.

Benda Anticipates 2008 Approval In India For Gene Therapy Product

SHANGHAI - China-Based Benda Pharmaceuticals anticipates 2008 approval from India’s Central Drugs Control Organization for its gene therapy product Gendicine for treatment of head and neck cancer. The company filed its application for the recombinant human Ad-p53 injection in November.

Pharmarama To Source Drugs For Chinese Clinical Trials

SHANGHAI - Pharmarama will begin sourcing pharmaceutical products for comparator clinical trials in China, the company announced Nov. 14 at BIO-Europe 2007 in Hamburg, Germany.

FDA Says Lack of Resources and Staff Hinder Its Foreign Inspections

Lack of resources and staff are two of the main reasons why FDA does not conduct more overseas pre-approval and post-market inspections, Deborah Autor, director of FDA’s Center for Drug Evaluation’s Office of Compliance, told generic drug makers meeting in Bethesda, Md.

Weekly Roundup: November 26, 2007

• Thailand's Low-Cost Generic Drugs Scheme a Boon for Poor (Thailand)
• Astellas to Spend Another Y40bn on Buybacks This Fiscal Year (Japan)
• Small Cap: Bionics to Test Anti-Cancer Drug on Humans (Australia)
• Chugai Pharmaceutical to Run 3 Domestic Plants Instead of 2 (Japan)
• Big Risks From Quick Drug Trials (Australia)
• China Pharma Q3 Revenue Hits $8.3 Million (China)
• Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials (China)
• MIT and India to Create Health Science and Technology Institute (India)
• U.S. Big 3 Look for New Indian Drug Suppliers (India)
• Manipal Group Sets Up Stem Cell Arm in Malaysia (Malaysia)
• Healthcare Sector Woos Investors (China)
• Pharma Firms Seek to List R&D Arms, but Funding Risks Remain (India)
  

India First Strategy Could Speed Up Data For FDA-EU Approvals - Mumbai Conference

MUMBAI – Pharmaceutical companies may be able to take advantage of the relative speed to market in India to commercialize products earlier and obtain postmarketing data that could bolster drug approval applications filed later in the U.S. and Europe, according to Biocon Founder and Chairman Kiran Mazumdar-Shaw.

Nicholas Piramal India Inks R&D Deal With Merck

Mumbai-based Nicholas Piramal India Limited inked a research and development deal with Delhi-based Merck subsidiary MSD Pharmaceuticals, NPIL announced Nov. 19.

Lilly Asian Ventures Looking For Chinese Companies To Invest In

SHANGHAI - Lilly Asian Ventures will focus on directly investing into individual companies under its second phase of investment in China, the firm announced Nov.7 in Shanghai.

China Implements Credit Ratings System for Drug Advertising

SHANGHAI – China’s State Food and Drug Administration announced Nov. 8 that it will implement new credit management measures to clamp down on illegal advertising of drugs, medical devices and health supplements.