Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially. Read More
Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019. Read More
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually. Read More
HONG KONG – Chinese biopharmaceutical company Abbisko Therapeutics Co. Ltd., of Shanghai, defied turbulent stock markets amid the COVID-19 pandemic to snag $70 million in its latest round of financing. Read More
Biopharma industry leaders in China who were the first to experience the chaos of the COVID-19 pandemic shared their thoughts during a closing plenary session of the virtual Bio-Europe Spring 2020 meeting. Read More
The five-day Bio-Europe Spring 2020 conference, possibly the first ever life sciences partnering event staged in an all-virtual format, ended on Friday, March 27, with high hopes that the industry would return to face-to-face interactions next year in Barcelona. Read More
HONG KONG – Phase II data of South Korea-based Qurient Co. Ltd.’s novel antibiotic candidate may offer hope that the first universal regimen to treat tuberculosis (TB) regardless of drug resistance status has been found. Read More
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep. Read More
BioWorld looks at translational medicine, including: How the eye cleans itself up; In blood stem cells, selection drives driver mutations early on; Dead cells do tell tales; Selective TGF-beta inhibition helps checkpoint blockade; How lung tumors seed to brain; Butyrate affects regulatory B cells, rheumatoid arthritis; Lamin A/C’s presence in nucleus, absence from membrane both problematic in progeria; Females, males have different metabolic response to intermittent fasting; Ditching PAMs expands CRISPR. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avexis, BMS, Cstone, Cytodyn, Eisai, Genentech, Humanigen, Intelgenx, Lupin, Mylan, Novartis, Pharming, Rockwell, Sanofi, Translate Bio. Read More
