SHANGHAI – Although China still has a way to go to approve any CAR T therapy, clinical development is robust with various targets being studied, and the regulatory environment is improving, cell therapy experts said at the Chinatrials 12 Summit.
SHANGHAI As Chinese biotech companies talk more about innovation, one question is whether they are ready to move into first-in-class drugs from me-too and fast follow-up drugs. Biotech executives said China still lacks the comprehensive ecosystem to support such time-consuming and high-risk R&D, but it is time to do so and they must go ahead.
SHANGHAI With abundant venture capital and favorable policies, Chinese biotech companies are actively turning themselves from generic makers into innovation-driven players, but the market is getting crowded by too many companies focusing on the same area and even the same targets, a reality that is leading to a lack of differentiation in biotech innovation.
SHANGHAI Now is the time for foreign pharmaceutical companies to include China in their strategies, as the country's recent regulatory reform, vast patient pool and lower costs represent opportunities to score approvals faster, said experts at the Chinatrials12 Summit.
HAMBURG, Germany Like any other sector, biotechnology has to engage with the wider political and economic environment it inhabits, as well as deal with the issues that are specific to it. A BIO-Europe panel discussion on transformative deals in 2019 concluded with a slightly nervous look ahead to what is increasingly looking like an uncertain macroeconomic situation.
BOSTON In a late-breaking oral presentation on the last day of The Liver Meeting 2019, Durect Corp. reported results from its phase IIa trial of DUR-928 for the treatment of alcoholic hepatitis. All 19 patients enrolled in the study survived for 28 days after treatment with DUR-928 , and all but two responded to the drug as measured by Lille scores, which is used for predicting risk of death.
HAMBURG, Germany Despite the biotech industry's recent record-breaking run in terms of fundraising and new drug approvals, the ongoing drug pricing controversy is acting as a drag on biotechnology investment. Since the debate started to heat up about four years ago, the Nasdaq Biotechnology Index is down 14%, while the S&P 500 Index is up by 46% during the same period, David Thomas, vice president, industry research at the Biotechnology Innovation Organization (BIO), told delegates attending the opening plenary session at BIO-Europe. "Something is clearly holding back investors in our space," he said.
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld. "I'm not going to call it the gold standard." Some of the reasons for denying biopsies a gold sticker are obvious. Biopsies are invasive, which makes them risky, expensive and loathed by patients and doctors alike. "In the real world, doctors don't always do biopsies – many say they very rarely do biopsies unless other data points in several directions and they need that for clarity," Gail Cawkwell told BioWorld.