Glenmark Pharmaceuticals Ltd., of Mumbai, India, reported preclinical findings suggesting that GBR 1302 is efficient at eliminating tumor cells and has potential for a large therapeutic window. Unlike current HER2-targeting therapies, GBR 1302 is designed to target both human CD3-epsilon and HER2 and is designed to effectively recruit cytotoxic T lymphocytes against HER2-positive cancer cells, bringing them in close proximity to the tumor cells. Data were presented at the European Society of Medical Oncology Symposium on Immuno-Oncology in Lausanne, Switzerland. Read More

NEW DELHI – With pharmaceutical sector regulations in urgent need of reforms, India has taken the first step, tightening rules for fixed-dose combination (FDC) drugs. Two key drug regulatory agencies, the Drugs Controller General of India and the Central Drugs Standards Control Organisation, have issued notices to several companies, guiding phase IV postmarketing surveillance trials and for manufacturing and selling FDCs in the country without approval from the Drugs Controller General of India. The letters to 283 companies are part of the country’s efforts to examine the safety and efficacy of FDCs licensed for manufacture or sale in the country. Read More

HONG KONG — The bacterial metabolite prodigiosin and its analogue, obatoclax, have been shown to have therapeutic activity in advanced breast cancer, providing the rationale for clinical trials, Chinese researchers reported in the Oct. 31, 2016, online edition of Proceedings of the National Academy of Sciences. Read More

MELBOURNE, Australia – With the global regenerative medicine market growing at 23 percent annually, Australia is well-positioned to play a significant role in that market, experts said during the AusBiotech conference. Read More

MELBOURNE, Australia – Some big deals in the biopharma space in Australia over the last year have gotten the attention of big pharma, and the sector is keyed up over the courtship possibilities. Read More

SHANGHAI – At the Clinical Trials 9 event last week, it was clear the biopharma industry’s optimism has not been dented by the recent CFDA rejection of 1,200 applications – about 70 percent of its workload – for poor quality or fraudulent data. While one would think so many questionable drug applications would cast a pall on the industry, especially among clinical trial experts, that is not exactly the case. Read More

HONG KONG – With the approval of blockbuster vaccine Prevenar 13, Pfizer Inc. is making a comeback into China’s vaccine market after being forced to shut down operations last year. Read More

SHANGHAI – During the ChinaTrials meeting in Shanghai last week it was clear that many China biopharmas view entering the U.S. market as necessary for long-term success. When looking ahead, they lack confidence the China market will sufficiently reward investments in new drugs. Even after sweeping regulatory reforms have been made in biopharma’s favor, reimbursement remains an issue. Read More