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.
Shares of Nextcure Inc. (NASDAQ:NXTC) have alternately been up sharply lately or down dramatically. Following the weekend release of updated positive clinical data from its NC-318 phase I/II study, the share price nosed down 52.9% Monday. Read More
Roche Holding AG and PTC Therapeutics Inc. together with their partner, the SMA Foundation, reported success in part two of the pivotal Sunfish study testing their survival motor neuron-2 splicing modifier risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA). Read More
BEIJING – Chinese clinical-stage cancer drug developer Tot Biopharm International Co. Ltd. went public on Hong Kong's stock exchange under the stock code of 1875 on Friday, raising HK$511.4 million (US$61.3 million) by issuing shares at HK$6.55 apiece. But its debut met with an unexpected setback, with share prices down nearly 7% in mid-morning. Prior to the listing, the company said its shares were oversubscribed by around 11.95 times and it "was well received by the capital market." Read More
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. Read More
MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back. Read More
LONDON – Sanifit Therapeutics SA has delivered positive phase IIb data demonstrating SNF-472 significantly reduces progression of cardiovascular calcification (CVC) in patients with end-stage kidney disease who are on dialysis. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer in National Harbor, Md.. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
