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.
With FDA approval secured for Rigel Pharmaceuticals Inc.'s Tavalisse (fostamatinib), company backers sought details about price and positioning, but heard they must wait for answers.
GW Pharmaceuticals plc CEO Justin Gover said solid science and years of cooperating with not only the FDA but also with the Drug Enforcement Administration (DEA) allowed his firm to reach the brink of an FDA panel meeting on its cannabidiol (CBD) oral solution for types of epilepsy, potentially followed by approval in June.
Kineta Inc.'s immuno-oncology (I-O) efforts have tended to grab the spotlight, but it's the push with alpha9/alpha10 nicotinic acetylcholine receptor (nAChR) antagonists in pain that drew a deal potentially worth more than $359 million with Genentech, a unit of Roche Holding AG.
