BEIJING – Biologics developer Hisun Bioray Bio-pharmaceutical Co. Ltd., a subsidiary of Chinese state-owned drugmaker Zhejiang Hisun Pharmaceutical Co. Ltd., received ¥3.8 billion (US$540 million) from Hong Kong investor PAG for a 58% stake in the company. Read More
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA). Read More
BOSTON – The gut microbiome and its prospects for drug development have been matters of debate for a while, sharpened by the high-profile phase II failure of Seres Therapeutics Inc.'s candidate, SER-109, in the summer of 2016. A panel at Biopharm America surveyed the space in light of developments since the stumble with that candidate, composed of about 50 species of firmicutes spores derived from stool specimens from healthy donors, against recurrent Clostridium difficile infection. Read More
CAR T cells engineered to target fibroblast activating protein (FAP) could reverse cardiac fibrosis and restore cardiac function in mice, researchers have reported in the Sept. 12, 2019, issue of Nature. Read More
With little more than a month to go before a trial begins in a multidistrict litigation (MDL) against several opioid manufacturers, privately owned Purdue Pharma LP is continuing its efforts to settle with all the plaintiffs involved. Read More
It's been a busy September for Ardelyx Inc. so far. Less than two weeks after the Fremont, Calif-based company reported promising pivotal data for tenapanor in chronic kidney disease patients with hyperphosphatemia, the sodium hydrogen exchanger 2 (NHE3) inhibitor won FDA approval for use in irritable bowel syndrome with constipation (IBS-C). Read More
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make that tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized. Read More
Nanoviricides Inc., of Shelton, Conn., plans to initiate a 1-for-20 reverse split of its capital stock, which will be effective after the market closes on Sept. 23, in order to maintain its NYSE American listing. Read More
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., said it has started an underwritten public offering of 8 million shares of its common stock, and underwriters have been granted a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering on the same terms and conditions. Read More
Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents Thursday after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms. Read More
