The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. The approval comes as several competitors, including Axsome Therapeutics Inc and Abbvie Inc., have NDAs submitted or approved for new therapies to treat migraine.
After seeing elevated alanine transaminase (ALT) levels consistent with drug-induced hepatotoxicity in its phase II study of ABI-H2158, Assembly Biosciences Inc. decided to discontinue development of the chronic hepatitis B virus (HBV) infection therapy.
Hebecell Corp. closed on a $53 million series A funding to continue advancing its off-the-shelf pluripotent stem cell CAR-natural killer cell (PSC-CAR-NK) therapy program into the clinic. Allen Feng, Hebecell’s chief scientific officer, has worked in stem cell development for more than 16 years. He’s seen a lot of technological change, especially in the past two years. Everyone is using the same technology, he said, but added that Hebecell’s technology is different from anyone else’s. It’s much simpler technology and has “very good potential” to move into large-scale industrial production.
Higher antibody titer levels were found in participants receiving two doses of Moderna Inc.’s COVID-19 vaccine compared to those receiving the Pfizer Inc.-Biontech SE vaccine, according to a research letter published in JAMA.
New data from Nrx Pharmaceuticals Inc.’s phase IIb/III trial for treating acute respiratory failure due to critical COVID-19 showed that Zyesami (aviptadil) improved the lung’s ability to transmit oxygen within a day of administration. The respiratory distress ratio’s average difference between those participants receiving aviptadil and placebo was clinically meaningful and statistically significant. The benefit was found across participants, all baseline severities and hospitals of all types.
Xalud Therapeutics Inc. raised an oversubscribed $30 million series C financing to continue advancing its lead candidate, XT-150, for regulating interleukin-10 in order to treat pathologic inflammation. The injectable, plasmid DNA gene therapy expresses IL-10v, a modified version of the cytokine IL-10, and is in a phase IIb study for treating moderate to severe pain caused by osteoarthritis (OA) of the knee.
Following new positive top-line results from its pivotal phase III study of IPX-203, Amneal Pharmaceuticals Inc. said an NDA submission for the Parkinson’s disease therapy (PD) is now planned for the middle of 2022.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
In one of the biggest collaboration deals of the year, Shape Therapeutics Inc. entered a collaboration and license agreement with Roche Holding AG to develop gene therapies for targets in areas that include Alzheimer’s disease, Parkinson’s disease and rare diseases. Seattle-based Shape is eligible to receive an initial payment, development, regulatory and sales milestone payments that could exceed $3 billion in aggregate value.
The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
