Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell. Read More
Durect Corp. (NASDAQ: DRXX) got a solid bump after announcing it granted Gilead Sciences Inc. exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product created with Durect's platform, Saber, in a deal that could generate more than $300 million for Durect. Read More
Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021. Read More
MEXICO CITY – The 2019 International AIDS Society (IAS) Conference on HIV Science kicked off over the weekend with the usual pre-conference workshops, including a workshop by the IAS Towards an HIV Cure initiative. Read More
HONG KONG – Sinomab Bioscience Ltd., a Hong Kong clinical-stage antibody firm, said its application for a Hong Kong IPO was accepted by the stock exchange, making it the 16th biopharma to submit an application under the new rules of the Hong Kong Exchange (HKEX). Read More
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success. Read More
The U.K.'s National Institute of Health and Care Excellence (NICE) said Monday it will be reviewing the methods it uses to develop guidance on drugs, medical devices and diagnostics so it can optimize its evaluation methods to ensure high quality and good value. Read More
Retrotope Inc., of Los Altos, Calif., closed a $20 million series C financing that was co-led by new investor Mehta Family Partners and current shareholder Timur Artemev. Read More
Contravir Pharmaceuticals Inc., of Edison, N.J., said its board approved the name change to Hepion Pharmaceuticals Inc., and the stock symbol to HEPA. Read More
