Welcome to this week's FiercePharmaAsia report, which includes savolitinib combo data in lung cancer, WuXi AppTec's acquisition of a U.S. CRO and the FDA's reinspection at Sun Pharma's Dadra plant.
1. AstraZeneca builds case for adding savolitinib to Iressa, Tagrisso
AstraZeneca and partner Chi-Med posted early phase 1b/2 data on the use of its MET tyrosine kinase inhibitor, savolitinib, in combination with Iressa or Tagrisso, which both target EGFR mutations. The combinatios triggered partial responses in a significant minority of non-small cell lung cancer patients who develop resistance to EGFR-TKIs as a result of MET amplification. It provides early evidence that savolitinib can play a role in NSCLC.
2. WuXi AppTec continues worldwide expansion with ResearchPoint Global buy
WuXi AppTec has acquired the U.S.-based CRO ResearchPoint Global, planning to fold RPG's existing service into WuXi’s existing clinical development service team. The acquisition and China’s recent regulatory move to allow foreign clinical trial data into new drug applications could mean more streamlined services for WuXi’s global customers.
3. India’s Sun Pharma says its Dadra manufacturing plant gets FDA clearance
Sun Pharma said its Dadra manufacturing facility has come back up to snuff in an FDA inspection after a warning letter from the agency. In a previous inspection, the FDA found 11 quality issues that included incomplete laboratory records and improper investigation of drug batches. Meanwhile, the company’s Halol plant continues to remain under FDA scrutiny, putting pressure on its bottom line.
4. Pakistani drugmakers eyeing Azerbaijan for JV manufacturing deals
The Pakistani ambassador in Azerbaijan said several pharmaceutical companies from his country are looking to develop joint ventures in drug production. In addition to drug manufacturing, Azerbaijan could also import surgical goods and medical instruments from Pakistan, he said.
5. Asymchem’s API plant gets passing grade from Australian regulators
Chinese drugmaker Asymchem Laboratories’ API plant in Dunhua successfully passed a four-day reinspection by Australian drug regulators. The manufacturing watchdogs carried out the inspection to see whether a GMP certificate for an Asymchem client’s NDA filing could be extended. The plant also passed an FDA inspection in March.