Clinical trial protocols have grown ever more complex, and that craving to capture larger and more diverse data points has begun to affect the efficiency of therapeutic development, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD). Read More
HONG KONG – Shenzhen-listed Harbin Gloria Pharmaceuticals Co. Ltd. plans to acquire a major stake in insulin maker Hefei Tianmai Biotechnology Development Co. Ltd. (HTBT) for ¥4 billion (US$600 million). Gloria is after HTBT's lead product, an oral insulin being co-developed with Israeli company Oramed Pharmaceuticals Inc. Read More
LONDON – Following a 20-month consultation and review, an independent U.K. bioethics body has concluded that heritable genome editing of humans could be allowed, as long as certain conditions are met. Read More
Hotspot Therapeutics Inc.'s $45 million in series A money will last three years and "gives us the dry powder to bring the company to the point where we'll start clinical studies" with two lead candidates, co-founder and CEO Jonathan Montagu told BioWorld. Read More
More than half of the $3.6 trillion spent on health care in the U.S. this year may be wasted, the Senate Health, Education, Labor and Pensions (HELP) Committee was told Tuesday in its second hearing on reducing health care costs. Read More
SHANGHAI – China's biotechs are benefiting from an unprecedented blood transfusion. Experienced executives from global pharma companies, and increasingly even big banks, are taking the leap to startups, leaving stable jobs behind. The incentive? Pay packages with stock options that can be worth tens of millions of dollars. Read More
Evolus Inc., of Irvine, Calif., filed a registration statement for an underwritten public offering of 5 million shares of its common stock. The offering is expected to consist of 2.5 million shares to be offered by Evolus and 2.5 million by a selling stockholder. Read More
Genmab A/S, of Copenhagen, Denmark, said worldwide net sales of Darzalex (daratumumab) as reported by New Brunswick, N.J.-based Johnson & Johnson were $511 million in the second quarter of 2018. Read More
Sonnet Biotherapeutics Inc., of Princeton, said it completed the discovery phase for its immunotherapy platform and commenced CMC development. Its platform leverages a scaffold based on the firm's albumin binding single chain antibody fragment for delivery of recombinant human-cytokines and other validated targets. Read More
More than a week after EU regulators began recalling drugs containing valsartan supplied by Zhejiang Huahai, of Linhai, China, the FDA announced that some valsartan products are being voluntarily recalled in the U.S. due to the possibility of impurities in the API. Read More
If anyone thought the controversy over the primary mode of action (PMOA) in combination products was resolved, the response to the FDA draft product jurisdiction rule shattered that belief. Two stakeholders, including the Advanced Medical Technology Association, said the draft fails to incorporate legislative requirements that the agency not use any chemical action as an excuse to determine the product is a drug, and thus revives the risk that a combo product will be misclassified. Read More
