The FDA's Endocrinologic and Metabolic Drugs Advisory Committee gave its blessing to semaglutide, voting 16-0 with one abstention to recommend that the candidate from Novo Nordisk S/A be approved for type 2 diabetes. Read More
Curevac AG's efforts in upgrading its mRNA vaccine platform over the past decade helped lead to its largest collaboration to date, a pact with Eli Lilly and Co. that comes with a $50 million up-front payment, an equity investment of €45 million (US$53 million) and up to $1.7 billion in potential milestones if all five cancer vaccine candidates are developed, plus tiered royalties on any products that make it to market. Read More
LONDON – The EMA is poised to go live with a new pharmacovigilance system which will see it take over responsibility for certain aspects of adverse event monitoring and analysis from national drug regulators. Read More
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) and Astrazeneca plc released positive preliminary safety and anti-tumor activity data of co-developed potential first-in-class inhibitor savolitinib in combination with other immunotherapy agents from two phase Ib/II experiments. Read More
SAN FRANCISCO – Following uncertainty, suspense and surprise in the heady political dramas around health care – outside of drug pricing controversies – predicting what else would unfold has been a perilous business. Nonetheless, policy mavens looking ahead to 2018 at the BIO Investor Forum gave it a go on Wednesday. Read More
A new Japanese study has shown that most mutations in induced pluripotent stem (iPS) cells arising during their generation occur in non-transcriptional areas of the genome. The authors argue this means such mutations are unlikely to cause malignancy. Read More
Optinose Inc., of Yardley, Pa., closed its IPO of 8.625 million shares at a price of $16 per share, which includes 1.125 million shares sold through the underwriters exercising their option to purchase additional shares, grossing the company about $138 million. Read More
Arbutus Biopharma Corp., of Vancouver, British Columbia, and Gritstone Oncology Inc., of San Francisco, entered a collaboration and licensing agreement in which Arbutus will deploy its lipid nanoparticle (LNP) technology to deliver Gritstone's RNA-based neoantigen immunotherapy products. Read More
Xbiotech Inc., of Austin, Texas, enrolled the first patient into a phase I single arm study evaluating the maximum tolerated dose of Onivyde (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. Read More
A lawsuit seeking damages from several drug and med-tech companies under the federal Anti-Terrorism Act was filed Tuesday in the U.S. District Court for the District of Columbia on behalf of 40 U.S. veterans and civilians, or their families, who were killed or wounded while serving in Iraq between 2005 and 2009. Read More
