Beginning in October, all opioids dispensed from pharmacies or doctor's offices in Canada must bear a bright yellow sticker warning that the drug can cause dependence, addiction and overdose, according to a Health Canada notice published in Wednesday's Canada Gazette. Read More
Inflarx N.V., of Jena, Germany, said it expects to raise gross proceeds of about $51 million through the sale of 1.5 million common shares offered at $34 each. The company intends to use net proceeds of the offering and cash on hand to support a phase IIb trial of its anti-C5a antibody in patients with hidradenitis suppurativa (HS) and a phase II program for the candidate in ANCA-associated vasculitis patients. Read More
The Institute for Clinical and Economic Review (ICER) released a draft evidence report assessing the comparative clinical effectiveness and value of elagolix (Abbvie Inc./Neurocrine Biosciences Inc.) for the management of endometriosis and associated pain. Read More
Tesaro Inc., of Waltham, Mass., reported net product revenue of $50.2 million for the first quarter of 2018, which included Zejula (niraparib), a PARP inhibitor approved for maintenance therapy in ovarian cancer, sales of $48.9 million, compared to $2.1 million for the first quarter of 2017. Read More
PERTH, Australia – Melbourne-based Starpharma Holdings Ltd. has entered a sales and marketing deal with Mundipharma International Ltd., which gives Mundipharma sales and marketing rights to Vivagel BV for bacterial vaginosis (BV) in Asia, the Middle East, Africa and the majority of Latin America. Read More
Any thoughts that the fortunes of public biopharmaceutical companies would change following a sub-par first quarter have been quickly dispelled after the sector chalked up another losing month with the BioWorld Biopharmaceutical index closing down about 2.5 percent that added to its overall 7 percent swoon since the beginning of the year. Read More
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." Read More
Arrevus Inc., a privately-held Raleigh, N.C.-based biotech designing proline-rich antimicrobial peptides for the treatment of infectious disease, has received a $1.5 million fast-track grant from the National Institute of Allergy and Infectious Diseases (NIAID) to expedite research on the effects of its lead candidate, ARV-1502, on bacteremia caused by multi-drug resistant pathogens. The award follows the closing of a $1.3 million series A financing from Tokyo-based MBL Venture Capital Co. Ltd. late last year that has helped the company accelerate its progress. Read More
Hours before its PDUFA date, Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] won accelerated approval from the FDA as the first antidote designed for use with rivaroxaban (Xarelto, Janssen Pharmaceuticals Inc.) and apixaban (Eliquis, Pfizer Inc./Bristol-Myers Squibb Co.) to reverse anticoagulation during life-threatening or uncontrolled bleeding. With its orphan drug and breakthrough therapy designations, Andexxa was approved based on change from baseline in anti-factor Xa activity in healthy volunteers. Read More
Genomewide association studies (GWAS) have so far underperformed in identifying genetic contribution to disease, but they have demonstrated that most genetic contributors to complex diseases consist of small contributions of relatively common variants, rather than large contributions of rare ones. Scientists at the Finnish University of Helsinki have developed a method to calculate a polygenic risk score for such common variants and used it to identify genetic contributions to migraine risk. Read More
