Brandon May

Mallinckrodt has filed for Chapter 11 bankruptcy amid growing lawsuits that allege the company has participated in fueling the opioid epidemic in the United States.
Since 1990, drug companies’ political committees have largely donated to Republican presidential campaigns. But that trend has noticeably reversed come the 2020 election cycle, according to a new report from the Center for Responsive Politics which shows that approximately 51% of total contributions in 2020 from biopharma organizations are being funneled toward Democrats.
The investigational drug, ARO-AAT, is a potential first-in-class treatment that reduces the generation of mutant alpha-1 antitrypsin protein (Z-AAT), the primary contributor to liver disease progression in patients with AATLD.
Eli Lilly is seeking Emergency Use Authorization for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).
Topline results from a 28-week Phase IIb trial show that lenabasum, a novel oral small molecule developed by Corbus Pharmaceuticals, did not reduce the rate of new pulmonary exacerbations compared with placebo in patients with cystic fibrosis.
The transaction between BridgeBio and Eidos is expected to close in the first quarter of 2021.
FDA
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
The expansion is part of the company’s acquisition of a 500,000-square-foot property that Aphena will renovate “into a state-of-the-art pharmaceutical and packaging and distribution facility.”
The Serum Institute of India (SII) has agreed to produce and deliver up to an additional 100 million doses of an approved COVID-19 vaccine for citizens of India and neighboring low- and middle-income countries as part of a collaboration with Gavi and the Bill & Melinda Gates Foundation.
The special purpose acquisition company, which has listed the units and is beginning to trade on the Nasdaq Capital Market, expects the proposed deal to command a market value of close to $500 million.
In addition to cutting staff, findings from the IW-3718-302 Phase III trial has caused the GI-focused healthcare company to discontinue development of IW-3718 and halt enrollment of its second Phase III trial, IW-3718-301.
Barry Bloom, Ph.D., research professor of public health and former dean at the Harvard T.H. Chan School of Public Health, participated in an online forum titled “The Coronavirus Pandemic: Global Race for a Vaccine” held September 15.
FDA
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
Endo International’s subsidiary, Par Sterile Products, LLC, has agreed to provide fill-finish manufacturing services to Novavax for commercial distribution of the vaccine company’s nanoparticle COVID-19 vaccine candidate.