Pharmaengine Inc., of Taipei, Taiwan, said the Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion recommending the granting of a marketing authorization of Onivyde (irinotecan liposome injection, nal-IRI) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) to treat metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy. Read More
HONG KONG – Japan's Chugai Pharmaceutical Co. Ltd. has licensed rights to its treatment for skin diseases to the company's Swiss partner, Galderma Pharma SA. The global agreement gives Lausanne-based Galderma rights to antibody nemolizumab, or CIM331. The drug is close to completing a global phase II study in the U.S., Japan and three European countries, for the treatment of atopic dermatitis. Read More
HONG KONG – Looking to continue morphing from a maker of active pharmaceutical ingredients (APIs) to a key biologic drug developer and manufacturer, Zhejiang Hisun Pharmaceutical Co. Ltd. has bought the rights to a targeted therapy for epithelioma in China from U.S. biotech company Nascent Biotech Inc. Read More
HYDERABAD, India – Following feedback from industry, health policy experts and the public, India recently updated its draft guidelines for biosimilars, narrowing down the conditions for waivers of late-stage trials and expanding some testing criteria. Read More
Sciclone Pharmaceuticals Inc. has wound down a strategic review process after having spoken with a number of potential buyers, deciding instead to remain a publicly listed company. The company said the board did not receive a bid that reflected a premium to the company's trading price. Sciclone plans to continue with growth plans for its China-focused commercial business. Read More
HONG KONG – A team of Chinese scientists from Sichuan University's West China Hospital in the city of Chengdu is one step closer to initiating the world's first human CRISPR clinical trial to test gene-editing technology in a lung cancer treatment. Read More
