Seattle Genetics Inc. priced an upsized public offering, grossing about $480 million to fund the ongoing growth of Adcetris (brentuximab vedotin) through efforts to expand the antibody-drug conjugate’s label and to advance the company’s pipeline Read More
Taking its turn before a joint meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management advisory committees (adcom), Collegium Pharmaceutical Inc. faced many of the same questions about its tamper-resistant, extended-release (ER) oxycodone candidate, Xtampza (formerly COL-003), that Purdue Pharma LP incurred the previous day about Avridi, its immediate-release oxycodone tablet. Read More
TOKYO – A series of reforms over the past year by Japan’s PMDA have cut down approval times, improved the level of science regulators expected to review drug and medical device applications and helped Japanese authorities strengthen ties with their peers around the world. Those efforts, and others, are aimed at positioning the country as a regulatory leader in Asia. Read More
BRADFORD, UK – Academic researchers have identified a variant of a human gene that determines how severely people are affected by viral infections, including influenza, dengue, yellow fever and Ebola, and have begun to uncover the mechanisms by which the gene product restricts viral entry into host cells. Read More
HONG KONG – Rules imposed by Sharia Law are often a concern for individuals or small companies in underfunded sectors in the Middle East and North Africa (MENA) region, but they are less of an issue for cash-rich industries. The good news is that most biomedical companies in MENA fall under the latter category. Read More
BRADFORD, UK – A technology for manufacturing tablets with integral 3D barcodes that can be read by conventional laser scanners promises to be an important new tool in combating the rising tide of drug counterfeiting, according to researchers at Bradford University who have been involved in its development. Read More
Trevena Inc., of King of Prussia, Pa., priced an underwritten offering of 6.5 million shares of its common stock, offered at $9.75 per share for a gross raise of $63.4 million. Read More
Arrowhead Research Corp., of Pasadena, Calif., said it nominated ARC-HIF2 as its first therapeutic candidate delivered using a new Dynamic Polyconjugate designed to target tissues outside of the liver. Read More
Mirati Therapeutics Inc., of San Digeo, reported that its receptor tyrosine kinase inhibitor, MGCD516, was well tolerated and showed favorable pharmacokinetic characteristics in unselected cancer patients during a phase I/Ib study. Read More
Yervoy (ipilimumab, Bristol Myers-Squibb Co.) was the first approved checkpoint inhibitor, and the first drug to affect the life expectancy of patients with late-stage melanoma. Read More
