LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX. Read More
Following a priority review of Orgovyx (relugolix), an oral hormone therapy developed by Myovant Sciences GmbH, the FDA has approved the medicine for the treatment of adults with advanced prostate cancer. The first success among three indications for which Myovant has developed the gonadotropin-releasing hormone (GnRH) receptor agonist, the green light marks Myovant’s transformation into a commercial-stage company, SVB Leerink analyst Ami Fadia noted. Company shares (NYSE:MYOV) fell 4.5% to $23.61 following the Dec. 18 approval. Read More
An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD). Read More
In what could end up being a deal that tops $1 billion, Merck & Co. Inc. cut a collaboration and license agreement with Janux Therapeutics to find, develop and commercialize T cell engager immunotherapies for cancer patients. Read More
Although FDA approvals in 2020 are falling just shy of records, the amount of regulatory news this year is more than twice the amount seen only four years ago and a 41% increase over that reported in 2019. The COVID-19 pandemic accounts for roughly 14% of the total, but regardless, by all accounts, 2020 has been an excessively busy year for both the biopharma industry and regulatory agencies. Read More
In the second half of November, Black Diamond Therapeutics Inc. gained attention from Wall Street by nominating BDTX-1535 as the firm’s development candidate for glioblastoma multiforme (GBM) and kicked off IND-enabling studies. Read More
HONG KONG – Peptidream Inc. inked a research collaboration with Amolyt Pharma SAS to test and optimize Peptidream’s growth hormone receptor antagonist (GHRA) peptides, with the aim of selecting a candidate to develop as a potential treatment for acromegaly. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Bavarian Nordic, Boehringer Ingelheim, Brainstorm Cell, Brii, Eusa, Glaxosmithkline, Medincell, Ology Bioservices, Prilenia, Recardio, Regeneron,Taiwan Liposome, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Antegene, Astrazeneca, Canbridge, Karyopharm, Novaremed, Novo Nordisk, Oyster Point, Polaryx, Synairgen. Read More
