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.
Adynxx Inc. used the same measure to select trial patients as other pain drug developers have used to weed them out – the Pain Catastrophizing Scale (PCS) – and arrived at what the company is calling a phase II success that greases the skids for a non-opioid phase III in a hard-to-treat patient sector.
In February, when Biogen Inc. said it was adding to the phase III effort with aducanumab in Alzheimer's disease (AD), language by the firm's chief medical officer (CMO), Alfred Sandrock, might have raised a red flag, or at least a pink one. "We did see more variability on the primary endpoint than assumed when we did the original sample size estimation, so we decided to increase the sample size" by 510 patients in the two studies, he said during a Leerink Partners health care conference.
