Pharma Koreana, Korea pharmaceutical news & reports, was established in 1991 and is now Korean leading pharmaceutical business newsletter. For the past years, Pharma Koreana has consistently provided senior executives in the pharmaceutical industry with the inside knowledge they need to compete and win! Readers are subscribers at the pinnacle of their careers as well as the rising stars of tomorrow. They turn to Pharma Koreana for its unique monthly package of Korean pharmaceutical news, analyses, commentaries and data.

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May  2008   Pharma Koreana
REGULATORY AFFAIRS

· Clinical trial protocol for Sutene approved
 · A total of 44 drugs approved between March 31st and April 11th
 · Clinical trial protocol for GSK Korea's Tykerb approved
 · Indications for Bayer Korea's Nexavar expanded
 · Clinical trial protocol for Korea Green Cross?Hepabig-Gene approved
 · Success in differentiation of stem cells into hepatocytes
 · KFDA begins to support pharmaceutical firms' compliance with process validation
 · Detailed criteria for pre-approval GMP compliance for each product prepared
 · Post-approval changes for 463 licensed drugs ordered
 · Administrative measures taken for 618 cases
 · Ninety four combinations of incompatible drugs in prescriptions additionally announced
 · Guidelines for pharmaceutical labeling upgraded
 · Report forms for equivalence testing to be standardized
 · Patient-oriented, disease-focused healthcare R&D system to be established
 · Criteria for re-evaluation of improved new drugs prepared
 · Drug benefits reduced for dispensation of incompatible or contra-indicated drugs without confirmation
 · License terms changed for ADHD treatments
 · Need for concrete plan for linkage of product licenses with patents suggested
 · Dong-A accelerating development of bio-drugs

MARKET INFORMATION

· Improved new drug version of Nexium approved
 · Price reduction in amlodipine maleate products drive pharmaceutical firms to promote another strategy
 · Mesoporous nanocompartment films for stimuli-free auto-modulated stepwise release of molecules developed
 · RNL Bio developing an oral medication for treatment of AI
 · Lycopene extracted from watermelons
 · Crystal structure of tumor suppression-involved protein complex elucidated
 · Yuyu's Yucrid approved
 · Daewoong launches CLA Plus Chrome
 · Samjin's pyrimidinedione derivatives found to be potent HIV type 1 and type 2 inhibitors
 · Dongkook's Pamiray reaches annual sales of more than ￦10 billion
 · Dongwha signs a $97 million worth licensing deal for DW1350
 · GMP facilities and quality control upgraded
 · R&D costs-to-sales ratios average 6.2%
 · Listed pharmaceutical firms achieve total exports of ￦450.3 billion
 · Pharmaceutical industry's R&D costs-to-sales ratio high in Korea
 · Dong-A and Yuhan show high growth in sales of drugs in pharmacies
 · Stock prices of 29 pharmaceutical firms fall
 · Progress in Pharmaceutical industries

REGULAR FEATURES

· Sewon Cellontech to export UCBSC RM Platform for the first time
 · Clotinab, Korea's first therapeutic antibody, to be exported to India
 · Pfizer and KRIBB to collaboratively develop an anticancer agent
 · Korean companies to advance into Japan with cellular immunotherapies
 · Genexel-Sein directly isolates mesenchymal stem cells
 · Genexel-Sein directly isolates mesenchymal stem cells
 · Chemizon signs a R&D service agreement with Takeda of Japan
 · Daewoong initiates a phase I clinical trial for anticancer gene therapy
 · Sewon Cellontech obtains European conformity certification for SRM Kit
 · VGX International obtains the license for an electroporation device
 · Intron obtains NET certification for its cloning vector technology
 · Success in differentiation of stem cells into hepatocytes
 · Industry keenly awaiting approvals for new bio-drugs in 2008
 · LG Life Sciences initiates a phase II clinical trial for an antidiabetic
 · Dong-A's Stillen first prescribed overseas
 · DHP Korea signs a license agreement for an ophthalmic antibiotic
 · Oscotec signs 'Contract manufacturing' agreement for its investigational drug
 · Yuhan licenses out Revanex to China
 · Yuhan licenses out Revanex to China
 · Kwangdong Pharm licenses in a natural new anticancer drug
 · VGX Consulting signs a consulting agreement with Pacific Pharm
 · Yuhan to introduce an antiemetic transdermal patch
 · Biotoxtech earns AAALAC accreditation
 · Hyundai announces introduction of CCMS

PROFILES

· Summary of Korean pharmaceutical manufacturers

KOREA PATENT INFORMATION

· CrystalGenomics obtains a patent for an anticancer drug candidate
 · Dongkook obtains a patent relating to a treatment of acromegaly
 · List of unexamined patents published between March 11th and April 10th, 2008
 · Abstracts for patents registered between March 11th and April 10th, 2008

WORLDWIDE PATENT INFORMATION

· Worldwide Patent News

REPORT

· Import & Export performance outlined in 2007
 · List of drug standard code for 382 items



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