Indian firms debut empagliflozin copies ahead of expected patent expiry for diabetes blockbuster Jardiance in the country. Spotlight now on how swiftly Boehringer Ingelheim can fend off the entrants and whether the local challenge goes well beyond “inspiration” from the goings-on in the case of another SGLT2 inhibitor dapagliflozin.

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

Despite multiple challenges including pricing pressures and slowing general economic growth, China offers attractive opportunities for emerging biopharma firms, helped by an encouraging regulatory environment. But weighing up options around challenging areas including partnering is essential, a new report states. 

Analysts expected at least $12m in third quarter sales, but the Alzheimer’s therapy brought in just $300,000. The company says educating doctors and procuring a coverage determination from CMS – not lower pricing – are key to growth.  

First interchangeable insulin biosimilar gains preferred status on one of the largest national formularies in the US.

An attempt to show efficacy even in younger people with mild COVID-19 symptoms has fallen flat in Phase II, and AT-527 will now lag behind rivals Merck and Pfizer.

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

The UK major is delighted with the German biotech's decision to throw in the regulatory towel with CVnCoV and concentrate on the firms' collaboration to development a second-generation COVID-19 vaccine. However, GSK is insisting that the partners look at both modified as well as unmodified mRNA approaches, a significant change of strategy for CureVac.

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

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.

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.