The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest. Read More
DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2. Read More
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery. Read More
Wall Street seemed to respond with thumbs down to positive data from the phase II study called Vadis with Sellas Life Sciences Group Inc.’s nelipepimut-S (NPS, or NeuVax) in breast ductal carcinoma in situ (DCIS), but the apparent reaction likely had little to do with the trial findings. Read More
PERTH, Australia – The University of Queensland (UQ) and CSL Ltd. are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase I trials. The response means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However, there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present, the partners said. Read More
For the first time since August, the volume of clinical data has dipped, with 388 items of phase I, II and III data in November, a 4% decrease compared with the prior month. Again, 17% of the entries during the month are focused on vaccines and therapeutics to fight the SARS-CoV-2 virus. The same percentage held true in October. The pandemic accounted for 16% of the clinical data in September, 15% in August and 16% in July. Read More
BioWorld looks at translational medicine, including: Psychedelic analog has therapeutic potential, Gene therapy in one eye improves vision in both. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active, Astrazeneca, Bristol Myers, Cipla, Fera, Immunitybio, Immunoprecise, Innate, Medivir, Neotx, Pear, Polyphor, Quralis, Tetralogic. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akari, Geron, Greenwich Lifesciences, Mitsubishi Tanabe, Prevail, Puma, Puretech Health, Scyneis, Sellas Life Sciences, Tychan. Read More
