SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi.
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline.
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
For Jeff Galvin, the CEO and founder of newly launched Addimmune Inc., HIV is not a condition that’s in the rearview mirror. It needs a functional cure to save lives, make people healthier and save money that need not have been spent. People wonder why it’s worth bothering to cure HIV, Galvin told BioWorld, when they are taking their medications every day and they are feeling pretty close to normal. But it’s not close for Galvin, who noted that there are side effects from taking the pills that can cause headaches, fatigue, nausea and diarrhea.
The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee.
As it nears the end of its cash runway and its lead antibiotic, Nuzyra, approaches a phase IIb readout, Paratek Pharmaceuticals Inc. agreed to be acquired by Gurnet Point Capital and Novo Holdings A/S for up to $3 per share in a deal that will take the company private.
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
Snipr Biome ApS has published initial clinical data showing its Crispr-Cas modified bacteriophage product selectively kills Escherichia coli – including strains that are resistant to antibiotics – with no effect on the rest of the gut microbiome. That paves the way to test Snipr-001 in the prevention of bloodstream infections in hematological cancer patients who, as a result of increased intestinal permeability caused by chemotherapy, are at high risk of gut bacteria getting into the bloodstream.
Aridis Pharmaceuticals Inc. has taken a few knocks in the past year but its new agreement with the U.S. FDA is giving it an opportunity to move forward. The company’s stock (NASDAQ:ARDS) rose 115% on May 31 to close at 39 cents per share as the company and agency agreed on the design of a single confirmatory phase III superiority study of AR-301 (tosatoxumab), an adjunctive therapy for treating pneumonia caused by gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients.
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