Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Reflexion, Roche, Transenterix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch Health, Bioreference Laboratories, Cherrycircle Software, Co-Diagnostics, Evisit, Luminex, Medable, MIP Diagnostics, National Kidney Foundation, Opko, Precheck Health Services, Qiagen, Science37, Veravas, Vitalhub.
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
The number of biopharmas and nonprofits pitching in to find a treatment for COVID-19 continues to grow. In the past few weeks, that number has more than doubled and it shows no signing of slowing.
Another volatile day of trading in health care stocks unfolded March 13, after a trebling of broader market carnage the day before and the declaration of a national emergency by U.S. President Donald Trump Friday afternoon. Substantial declines hit shares of Moderna Inc., Vaxart Inc. and Inovio Pharmaceuticals Inc., all of which had recently rallied on optimism over coronavirus-fighting efforts. Biopharma shares saw some recovery, with both the S&P 500 Health Care Sector and Nasdaq biotechnology indices each rising a bit more than 2% each before Friday's close.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Can-Fite, I-Mab, La Jolla, Lattice, Lexicon Pharmaceuticals, Lilly, Neuexcell Therapeutics, Pharmamar, Qiagen, Redx Pharma, Roche, Sengenics, Verastem.
Sientra Inc., of Santa Barbara, Calif., reported gains in both its breast products and Miradry segments during its fourth-quarter earnings call after the close of the market March 11. For his part, CEO Jeff Nugent noted that the company had experienced record total net sales in the fourth quarter of $23.2 million, representing growth of 22% year-on-year. However, the company provided full-year 2020 guidance for 12% to 17% growth, which William Blair’s Margaret Kaczor said was below her organization’s 22% estimate, “though the shortfall is largely a result of negative impacts from COVID-19.”
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