Scientists from the German Leibniz Institute for Experimental Virology and the Bernhard Nocht Institute for Tropical Medicine have discovered that T-cell dysregulation is an important facet of the immune system response to Ebola virus disease. Read More
Intarcia Therapeutics Inc., of Boston, said top-line results from its 4,000-plus-patient FREEDOM-CVO cardiovascular safety study showed it met all clinical endpoints. Read More
Recyte Therapeutics Inc., a subsidiary of Biotime Inc., both of Alameda, Calif., said a paper reporting the isolation of pericyte-like cells from human embryonic stem cells was published online in Scientific Reports. Recyte researchers said the pericyte-like cells represent a type of cell that is specialized to support and strengthen blood vessels. The pericytes may serve as a source of cells to promote new blood flow in patients suffering from ischemic vascular disease, according to the company. Read More
Intellia Therapeutics Inc., of Cambridge, Mass., said it priced its IPO of 6 million shares of common stock at $18 per share for gross proceeds of $108 million. Read More
PTC Therapeutics Inc., of South Plainfield, N.J., reported net sales of Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) totaling $18.9 million for the first quarter. Read More
Wall Street must wait for later this week to find out more from Kempharm Inc. about FDA talks ahead and further steps with Apadaz (KP201/APAP) for pain, but meanwhile an advisory panel's vote against the compound's abuse-deterrent properties sent shares (NASDAQ:KMPH) into a tailspin Friday to close at $6.91, down $8.76, or 55.9 percent. Read More
Anticipating an FDA complete response letter (CRL) for rociletinib, Clovis Oncology Inc. quit enrolling ongoing studies of the drug, withdrew its European marketing authorization application (MAA) filing and expects to trim its headcount by 35 percent from its 2015 level by year-end. In wake of the reckoning, Clovis is turning its full attention to potential approval and commercialization of its PARP 1-3 inhibitor, rucaparib. Read More
LONDON – Ergomed plc is branching out from its core business as a contract research organization (CRO) to acquire Haemostatix Ltd., a specialist in synthetic coagulants for use in surgery. Read More
HONG KONG – A study by Taiwanese researchers has demonstrated that two glycoproteins are highly expressed in glioblastoma multiforme (GBM) cancer stem cells, and they play a key role in the tumorigenicity of the brain cancer. Both represent promising new potential therapeutic targets against the largely incurable disease. Read More
NEW DELHI – India's revised draft guidelines for biosimilars have drawn mixed reactions. The country's pharma industry has, in broad strokes, welcomed the increased clarity and more rigorous conditions in the revised guidelines, but the Organisation of Pharmaceutical Producers of India, comprising largely foreign pharma firms, said the new rules could compromise patient safety. Read More
BOGOTA, Colombia – Less than two months after Peru issued technical standards to register and re-register biosimilars, the new regulations are generating buzz in the country's biopharma space. Read More
