Reacting to the FDA's extension by three months of the PDUFA date for Tegsedi (inotersen), Akcea Therapeutics Inc. CEO Paula Soteropoulos said the company does "not see the potential that this brings an advisory committee into the picture at all," and the shift by regulators was "purely [due to] the volume of data they have to go through."
The recent deal between OSE Immunotherapeutics SA and Boehringer Ingelheim GmbH may have brought renewed interest in CD47, a controversial target in immuno-oncology (I-O), but plenty of biotech outfits started before word of the tie-up. Nantes, France-based OSE licensed the preclinical SIRP-alpha antibody OSE-172, to Boehringer, of Ingelheim, Germany, for €15 million (US$18.5 million) up front, with the potential for another €15 million when the phase I study starts. Down the road, OSE could collect more than €1.1 billion if undisclosed development, commercialization and sales milestones are met, plus royalties on worldwide net sales.
Despite Wall Street's harsh reaction to Esperion Inc.'s second, successful phase III trial with bempedoic acid (BA) in dropping low-density lipoprotein cholesterol (LDL-C), analysts found the data salutary in the big picture and supportive of approval. "All in all, there are some positives here and it's good enough to cross the bar in our view, but also [there are] some issues [that] the bears will try to harp on vs. 'expectations,' which is what is impacting the stock," wrote Jefferies' Michael Yee in a report.
The latest chapter in Siga Technologies Inc.'s arduous history with Tpoxx (tecovirimat) closed happily with the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voting 17-0 to recommend approval of the smallpox vaccine caused by variola virus in adult and pediatric patients.
Although exact terms were not disclosed, 4D Molecular Therapeutics Inc. (4DMT) CEO David Kirn told BioWorld that Roche Holding AG has "significantly increased" its funding commitment, broadening the research from "a small handful of rare retinal disease indications" in 2016 to take in ophthalmology bids that include large-market prospects as well.
TG Therapeutics Inc. CEO Michael Weiss said he expects the firm's anti-CD20 therapy for multiple sclerosis (MS) will become available "at the right time with the right message, with convenience and price" at the forefront of patients' minds. "They're angry about the pricing. Drugs that cost them, less than 10 years ago, $10,000 to $15,000 a year are now $80,000 a year. And they just can't understand why."
Astrazeneca plc spinout Corvidia Therapeutics Inc.'s $60 million in series B money should let the company "expand into earlier stages of chronic kidney disease [CKD] and apply our scientific approach further into areas of heart failure," CEO Marc de Garidel told BioWorld, adding that the company is "investing to further build our pipeline assets and accelerate some of these therapies into clinical trials."
Clovis Oncology Inc.'s win earlier this month that broadened the label for Rubraca (rucaparib) tablets in ovarian cancer put the poly (ADP-ribose) polymerase (PARP) inhibitor on more level ground with competitors Tesaro Inc. and Astrazeneca plc, setting pundits abuzz about the competitive odds and how the market might further slice the PARP pie.
With a phase III candidate that CEO Matthew Pauls said could be positioned as "the first-line, first-choice medicinal therapy for Cushing's syndrome [CS]," Strongbridge Pharma plc kicked off a second late-stage trial to test Recorlev (levoketoconazole), an oral cortisol synthesis inhibitor.
Advances made during the last five to seven years in cannabis-based therapies equal about 50 years' worth of the same in the pharmaceutical industry overall, George Scorsis, CEO of Liberty Health Sciences Inc., told BioWorld. Federal legislation to enable more experiments with marijuana will keep the pace brisk, along with work by the likes of GW Pharmaceuticals plc.
