CEO Andrew McDonald told BioWorld that Attune Pharmaceuticals Inc. made 1,200 compounds – "a tour de force, from a medicinal chemistry perspective" – in order to find two that worked the way the company wanted as oral plasma kallikrein inhibitors in the prophylactic treatment of hereditary angioedema (HAE).
Company watchers remained upbeat as analysts during a conference call Friday pressed Immunomedics Inc. for details about the complete response letter (CRL) regarding the BLA related to antibody-drug conjugate (ADC) sacituzumab govitecan for metastatic triple-negative breast cancer (TNBC).
Investors awaiting word from Immunogen Inc. in the first half of this year regarding the phase III trial called Forward-1 in platinum-resistant ovarian cancer continue to debate the odds of success with antibody-drug conjugate (ADC) mirvetuximab soravtansine. Previously known as IMGN-853, mirvetuximab soravtansine targets folate receptor alpha (FRa).
When he took the position about a year ago, CEO Joe Turgeon of Spectrum Pharmaceuticals Inc. saw "right off the bat, when I met with my senior staff" that the company needed to change, he told BioWorld. "We had these important products, but they were small niche products, and we were classified as a specialty pharma company."
What Oppenheimer analyst Leland Gershell a few months ago called "the shift toward non-opioid/locally delivered treatment strategies [in pain], driven by increasing regulatory/payer/institutional hurdles" has brought a handful of players to the fore.
Norwood, Mass.-based Corbus Pharmaceuticals Inc.'s deal earlier this month with Kaken Pharmaceutical Co. Ltd., of Tokyo, to develop and commercialize lenabasum for systemic sclerosis (SS) and dermatomyositis (DM) in Japan shone more light on drug developers' prospects in the former indication, but interest already ran high in some quarters.
Trouble surfaced early in the joint meeting of the FDA's Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee for Takeda Pharmaceuticals Co. Ltd. with the supplemental NDA for xanthine oxidase inhibitor (XOI) Uloric (febuxostat).
What Oppenheimer analyst Leland Gershell a few months ago called "the shift toward non-opioid/locally delivered treatment strategies [in pain], driven by increasing regulatory/payer/institutional hurdles" has brought a handful of players to the fore.
With a new CEO imported from Novartis AG, Urogen Pharma Ltd. popped the cork on eagerly awaited top-line data from the ongoing pivotal phase III trial called Olympus with UGN-101 (mitomycin gel) for instillation, a nonsurgical treatment of low-grade upper tract urothelial cancer. "It's a very creative solution to a nagging problem, which is how to take care of these patients, most of whom end up losing their kidneys because we don't have a lot of alternatives," New York-based Urogen's chief medical officer, Mark Schoenberg, told BioWorld.
