Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.

The biopharma market has been highly active throughout the COVID-19 pandemic with a substantial focus on strategic alliances between 2020-H1 2021. Partnership deals present exciting liquidity and risk mitigation opportunities for early-stage companies. Small molecules still comprise the largest segment of partnered drugs, but alliances for other modalities are on the rise.

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.

Biocon chairperson Kiran Mazumdar-Shaw says that venture capital firms have, with their risk-averse approach, "failed" the biotech sector in India. The executive draws attention to how "bold" venture funds that backed mRNA technology a decade ago were reaping gains today.