The "soil of the human body" and the extrahuman life it supports are an underappreciated player when it comes to developing immunotherapies and other precision medicine approaches, Vince Young, a professor at the University of Michigan Medical School, said in his keynote address at Monday's FDA workshop on the science and regulation of live microbiome-based products to treat disease. Read More
LONDON – Realm Therapeutics plc is pulling the plug on attempts to reshape itself as dermatology specialist after the lead program PR-022 failed in a phase II study in atopic dermatitis. Read More
"We wanted to get this product to patients as quickly as possible," Joshua Cohen, senior director and therapeutic area lead for migraine and headache at Teva Pharmaceutical Industries Ltd., said in explaining the subcutaneous formulation of Ajovy (fremanezumab-vfrm), approved by the FDA late Friday to prevent migraine. Ajovy became the second calcitonin gene-related peptide (CGRP) entry in the U.S. migraine space, joining Aimovig (erenumab) from Amgen Inc., approved in May. Read More
DUBLIN – Shares in Argenx NV hit a 12-month high during early trading Monday on news that its fragment antibody, efgartigimod (ARGX-113), exhibited an efficacy signal in a small-scale, phase II trial in primary immune thrombocytopenia (ITP), which puts it on course for a pivotal phase III trial. Read More
HONG KONG – China has seen a busy month of drug approvals, from Lenvima (lenvatinib, Eisai Co. Ltd. and Merck & Co. Inc.) on Sept. 5 to Elunate (fruquintinib, Hutchison China Meditech Ltd.) and Soliris (eculizumab, Alexion Pharmaceuticals Inc.) on Sept. 6. More notably, the three drugs, all accepted under the priority review pathway, were granted marketing approval in about a year. Read More
Having sold its only candidate to Roivant Sciences Ltd., San Diego's Patara Pharma Inc. is re-launching as Respivant Sciences Inc., becoming the 13th "Vant" launched by the Basel-based conglomerate. Current plans call for a phase IIb dose-ranging study of the drug intended to reduce chronic cough in patients with idiopathic pulmonary fibrosis (IPF), which is set to begin in the first quarter of 2019. The drug, RVT-1601, is a new formulation of the well-known mast cell stabilizer cromolyn sodium, intended for delivery via a nebulizer already used in other approved products. Read More
Nemaura Pharma Ltd., of Loughborough, U.K., said it entered a license agreement with an undisclosed global pharma firm to develop three new transdermal patch products. Financial terms were not disclosed. Read More
Endocyte Inc., of West Lafayette, Ind., said it closed an underwritten registered public offering of 10.87 million shares, which includes the full exercise of the underwriters' option to purchase additional shares of common stock, at $18.50 per share, for net proceeds of approximately $188.7 million, which it intends to use to fund the continued clinical development of its pipeline products and preparation for the commercial launch of 177Lu-PSMA-617, if approved, as well as for working capital and general corporate purposes. Read More
The National Whistleblower Center (NWC), a whistleblower advocacy group, Monday asked the U.S. SEC to extend the public comment period for proposed changes to its whistleblower program. The comment period is scheduled to end Tuesday, but the NWC wants the SEC to produce nearly 16,000 emails and other documents the group requested under the Freedom of Information Act (FOIA) before ending the comment period. Read More
