In the wake of Study 045’s failure with Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. is “trying to thread the needle between the notion of getting Study 041 completed in the third quarter of 2022 vs. getting accelerated approval now,” CEO Stuart Peltz said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achilles, Astrazeneca, Covaxx, GSK, I-Mab, PTC, Sanofi, Spark, Spero.
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol, eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
Vaxart Inc. investors who stuck by company shares Feb. 3 had to swallow a bitter pill – watching shares of the oral vaccine developer (NASDAQ:VXRT) fall 57.8% to $9.85. Driving the trade in part was news that, during a phase I trial, neutralizing antibodies to SARS-CoV-2 were not detected in most of the five subjects given two doses of VXA-CoV2-1, its oral recombinant protein vaccine for the potential prevention of SARS-CoV-2 infection. Furthermore, the company concluded it was "unable to evaluate" a study of the candidate organized by Operation Warp Speed.
The numbers are staggering when it comes to the potential drug risks pregnant and breastfeeding women, as well as their babies, are exposed to and the treatments they may be denied because of the lack of data.
CAJICA, Colombia - Colombia approved two different phase II/III trials for COVID-19 vaccine candidates over the last week, advancing one candidate developed by Germany’s Curevac AG and another by China’s Clover Biopharmaceuticals Inc.
LONDON – Two new U.K. studies point to long-term persistence of COVID-19 antibodies after both natural infection and vaccination, conferring protection against subsequent infection for at least three months.
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