Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002).
Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
The error in phase III data reported in late October that sank Galera Therapeutics Inc.’s stock (NASDAQ:GRTX) has been corrected, prompting share values to nearly double on Dec. 14. The error, according to J. Mel Sorensen, Galera’s president and CEO, had resulted in a false “p” value, leading the company to report the study had failed to achieve statistical significance on its primary endpoint. He called the programming error that caused the confusion “quite subtle.”
Foghorn Therapeutics Inc. is receiving $300 million up front in cash in its new collaboration with Loxo Oncology at Lilly to develop oncology medicines. Foghorn could bring in up to $1.3 billion in development and commercialization milestones. In addition, Lilly will invest $80 million in Foghorn.
In 2021, progress on preventing and treating COVID-19 was a seemingly endless series of starts and stalls. In spite of the high-profile stumbles, science and finance took startling steps forward.
Core presentations at the 63rd meeting of the annual American Society of Hematology (ASH) began Saturday morning with the presentation of three studies focused on non-Hodgkin lymphomas and one on multiple myeloma (MM). Each approach used the immune system as a cancer fighter but employed different mechanisms of action. Two of them successfully used CAR T therapies as treatment.
Two reports, one from Democrats and one from Republicans, point fingers at the reasons prescription drug prices have risen so dramatically. Both came at a time when President Joe Biden wants to change the way drug prices are determined.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
