Infectious Diseases

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

From the latest COVID-19 advances to the emergence of a game changer for heart failure, Scrip’s editor in chief Eleanor Malone reviews the big stories of the past three months. Safety issues around JAK inhibitors and AAV vector-based gene therapy were also to the fore, while biopharma financing continued apace.

While Bharat Biotech is close to an accelerated approval of Covaxin in two to 18-year-olds, Zydus Cadila is yet to roll out its COVID-19 vaccine in India. As they head to a face-off in pediatric vaccines, the former faces manufacturing constraints and the latter hesitance over a first of its kind DNA vaccine. Experts speak to Scrip on which one stands a better chance of winning.

The company created two new divisions focused on the new disease areas, bringing in former executives from Bristol Myers Squibb and Sanofi Pasteur.

Chief scientific officer Paul Stoffels will retire at the end of the year at the same time CEO Alex Gorsky will hand over the top leadership role to Joaquin Duato; no successor has been named.

Vedanta thinks its live biotherapeutic sourced from clonal cell banking could offer strong prevention against C. difficile infections after antibiotics have cleared an initial infection.

Merck/Ridgeback’s ribonucleoside analog shows nearly 50% reduction of risk for hospitalization or death in Phase III study. Firms will seek EUA in US; a contract is in place for 1.7 million courses of therapy.

License deal for preclinical S-365598 continues longstanding R&D relationship between ViiV and stakeholder Shionogi, which also developed dolutegravir and cabotegravir.

The French drug maker isn’t moving its mRNA COVID-19 vaccine into Phase III, instead focusing on a GSK-partnered protein SARS-CoV-2 vaccine and applying mRNA technology elsewhere.

What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.

Biotech says rezafungin should best existing echinocandin agents in treatment of Candida pathogen infections, while also offering needed prophylaxis improvements for leukemia and lymphoma patients.

J&J announced strong data for its single-shot vaccine, with even stronger booster shot data to boot. Also Gilead posted strong results for outpatient use of Veklury, but it faces stiff competition, while Clover announced new data and Pfizer/BioNTech sold another 500 million vaccine doses for donation.