With the FDA approval of Novartis AG’s Isturisa (osilodrostat), an oral treatment for adults with Cushing’s disease, Recordati SpA, of Milan, is planning its U.S. market launch for the second or third quarter of this year. Recordati, which acquired Isturisa’s worldwide rights from Novartis in October for $390 million, expects sales to peak at $100 million annually. Read More
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts. Read More
The financial markets were delivered a one-two punch March 9 – a plunge in oil prices along with fears that the coronavirus is continuing to spread unabated. As a result, the Dow Jones Industrial Average cratered 1,500 points in early trading after a brief halt with market circuit breakers kicking in. Biopharma equities did not escape the carnage, with the BioWorld Biopharmaceutical index trading down about 4% by market close, with the Dow closing down 7.8%. Read More
Kala Pharmaceuticals Inc. plans to use its positive phase III data in dry eye disease (DED) with KPI-121 (loteprednol etabonate ophthalmic suspension 0.25%) as the basis for the resubmission of its NDA in the second quarter of 2020. Read More
With Friday’s last-minute decision to move to an all-virtual format, the opening session of the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) was certainly an unusual one. “We are in uncharted waters,” conference co-chair Sharon Hillier, Richard Sweet Professor of Reproductive Infectious Disease at the University of Pittsburgh School of Medicine, told the audience via livestream. Read More
HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic. Read More
DUBLIN – Hansa Biopharma AB is nearing a key milestone in its evolution, as a regulatory decision on its first marketing authorization application (MAA) looms. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to deliver an opinion during the second quarter on its application for imlifidase in supporting kidney transplants in sensitized patients. Read More
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, BMS, Compugen, Cytodyn, Dare, Faron, FSD, Gemoab, Kala, Retrophin, Revolution, Terns, Viiv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Athenex, Avrobio, Boehringer Ingelheim, F2G, Immutep, Mylan, Nicox, Novartis, Pharming, Valneva. Read More
