Provention Bio Inc., of Oldwick, N.J., said it closed its IPO of shares at $4 each for gross proceeds of approximately $63.9 million. The shares will begin trading on Nasdaq under the ticker symbol PRVB Tuesday, July 24. Read More
Scientists from the Georgia Institute of Technology have developed polymeric microparticles that could be loaded with therapeutic bacteriophages, and delivered to the lungs via inhalation. Treatment with the phages protected both regular mice and mouse models of cystic fibrosis from otherwise lethal infections with Pseudomonas aeruginosa. Read More
The EU and Japan are expanding the mutual recognition agreement they signed in 2004 to broaden the range of medicines for which they will recognize each other's manufacturing inspections. The agreement will now extend to sterile drugs, certain biologics including vaccines and immunologicals, and the active pharmaceutical ingredients of any medicine covered in the agreement. Read More
Beigene Ltd., of Beigene, China, said it attended a hearing before the listing committee of the Stock Exchange of Hong Kong Ltd. (HKEX) in connection with its application to list its ordinary shares on the main board of HKEX. Read More
TAIPEI, Taiwan – Precision medicine was a big topic at BioTaiwan, with one very local case study highlighting the promise of both the evolving field, as well as Taiwan's role as a clinical research location – a role the government is seeking to expand. Read More
Researchers from the Japanese Kobe and Kyoto Universities have demonstrated that in mice, innate immune activation via Toll-like receptors (TLRs) was necessary for social defeat stress to translate into depressive behaviors. Read More
LONDON – The U.K. government is to start issuing advice to companies to prepare for a cliff edge Brexit in which there is no agreement on the terms of withdrawal by the end of March next year. Read More
This month's guidance from the FDA regarding gene therapy development put even more oomph behind PTC Therapeutics Inc.'s buyout of Agilis Biotherapeutics Inc., a move that brings aboard four programs, including one due for a BLA next year. Read More
A month ahead of its Aug. 21 PDUFA date, Tibsovo (ivosidenib, formerly AG-120) received full FDA approval Friday to treat adults with relapsed or refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The oral drug, developed by Agios Pharmaceuticals Inc., became the first FDA-approved therapy in the targeted indication and the first in the class green-lighted with an FDA-approved companion diagnostic, the Abbott Realtime IDH1 test. Read More
LONDON – Puretech Health plc sealed a potential $1 billion research and development agreement with Roche Holding AG, to use exosomes derived from milk as an oral delivery vehicle for antisense oligonucleotides. Read More
With the clock ticking on a Nov. 20 PDUFA date, Swedish Orphan Biovitrum AB (Sobi) swooped in to acquire global rights to emapalumab (NI-0501) from developer Novimmune SA in exchange for CHF50 million (US$50.3 million) up front in cash and additional payments totaling CHF400 million (US$402.3 million) over an eight-year period. Read More
