Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move. Read More
DUBLIN – Zealand Pharma A/S has up to now generated its pipeline of peptide drugs internally, but it has gone hunting in biotech's bargain bin to find its first externally sourced asset. Read More
Despite Provention Bio Inc.'s phase IIa top-line data showing PRV-6527 in Crohn's disease did not differentiate from placebo, the company's stock was bumped back less than 1% on Tuesday as it continued to ride high after June's massive leap on heartening data about the company's type 1 diabetes trial of teplizumab. Read More
In another marathon session Tuesday, the third U.S. House committee with jurisdiction over prescription drug pricing issues marked up H.R. 3, the Lower Drug Costs Now Act, clearing the way for a House vote on the partisan measure yet this month. Read More
CLEVELAND – What are some of the biggest challenges related to using artificial intelligence (AI) in health care? A panel of experts tackled that question during a session Tuesday during the 2019 Medical Innovations Summit, while also discussing what their organizations have done in that space to advance patient care. Read More
While the general markets are leaning toward positive territory following a quiet summer period, the enthusiasm for biopharma equities remains muted. One of the most closely monitored therapeutic areas is oncology. Earlier this year, public companies developing innovative medicines in that area had enjoyed strong support; however, investors now appear to be more selective in backing companies in that sector. Read More
HONG KONG – South Korea's biopharmaceutical venture Genome & Co. Ltd. recently secured KRW30.2 billion (US$25.2 million) in series C investment with an IPO and global clinical trial plans for next year. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
