Albireo Pharma Inc., of Boston, said Japan's Ministry of Health, Labor and Welfare approved the new drug application for IBAT inhibitor elobixibat for the treatment of chronic constipation, triggering payments from Eisai Co. Ltd. subsidiary EA Pharma Co. Ltd., of Tokyo, under a license agreement and from Healthcare Royalty Partners under the terms of a royalty monetization agreement disclosed earlier this year, which together total more than $55 million. Read More
Xbiotech Inc., of Austin, Texas, reported results from the open-label extension portion of a phase II trial testing MABp-1 in patients with hidradenitis suppurativa. Read More
Pfizer Canada, a unit of New York-based Pfizer Inc., advised Health Canada that there is a shortage of Epipen auto-injectors in the 0.3-mg format, reported due to a manufacturing disruption currently anticipated to be resolved by March 2. According to Pfizer, the shortage does not impact Epipen Jr (0.15 mg) products, which remain available. Read More
Metastases cause a large majority of cancer deaths, and understanding their mechanisms might offer therapeutic opportunities. A team from Case Western Reserve University investigated a possible role of enhancers, regulatory DNA elements that can influence the transcription of downstream genes. Read More
Motif Bio plc, of New York, said it filed a universal shelf registration statement with the SEC, which will enable the firm to sell, in one or more offerings, up to an aggregate of $80 million of ordinary shares, including American depositary shares, preference shares, warrants, subscription rights, debt securities and a combination of such securities, separately or as units. Read More
PERTH, Australia – Australia's Imugene Ltd. could be the first biotech out of the gate in developing B-cell peptide vaccines in the immune-oncology space. Read More
By looking for a combination of DNA and protein biomarkers, a single experimental blood test could detect eight different cancers, and identify the anatomical location of the majority of tumors it detected. Read More
With the prospect of a U.S. federal government shutdown appearing ever more likely Friday, the potential tolls that action might take on the FDA, NIH and other federal elements crucial to industry's forward momentum became clearer in some respects, but not others. Read More
While Agios Pharmaceuticals Inc. waits to hear from the FDA about its acute myeloid leukemia (AML) therapy's NDA, the company is mulling the prospect of an eventual label "in newly diagnosed patients unfit for any therapy," CEO David Schenkein said, and it's ambitions of that caliber that helped the company raise $475 million in a public offering set to close Tuesday. Read More
Last year, there were 1,015 biopharmaceutical deals recorded by Cortellis Deals Intelligence, with projected values at signing of $80.89 billion. This total represented a slight 3 percent drop on the deal totals calculated in 2016, and a 24 percent decline over 2015, despite the fact that the deal volume was 24 percent and 12 percent higher than the 2016 and 2015 volumes, respectively. Read More