Copiktra (duvelisib) becomes the first dual inhibitor of PI3K delta and gamma to hit the market, placing it in competition with Gilead’s Zydelig and AbbVie’s Venclexta.

Imfinzi will be the fourth PD-1/L1 inhibitor approved for lung cancer in Europe, but AstraZeneca could carve out a niche by being indicated for sequential use following chemoradiation.

The Swiss drug maker will cut 1,700 jobs in manufacturing and business services in Switzerland by 2022 and another 395 jobs in the UK.

Public Company Edition: Eli Lilly & Co. wasted no time spinning out its animal health business Elanco, which raised $1.5bn in its public debut. Also, as the biopharma IPO tally rises, Vivo Capital launches a new public life science company fund. Meanwhile, Concordia completes its recapitalization.

Clinuvel's Scenesse for the ultra-rare, light-induced disease erythoropoietic protoporphyria (EPP) is already approved in Europe and the company is hopeful that a rolling NDA submission could pave the way for a US launch.

Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.

Helped by new guidelines, South Korean pharma and biotech firms now have clearer standards related to the reflection of R&D costs in their accounting books, with some pointing out that biosimilar companies may be the biggest beneficiaries. 

Pifeltro and Delstrigo have been backed for approval by the CHMP but how well they will fare on the market depends on a competitive pricing strategy and continuing to benefit from current European guidelines which recommend NNRTI-containing regimens for HIV.

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Full PACIFIC data show strong overall survival benefit in all comers, though not in a post hoc analysis of those with low PD-L1 expression, about 20% of the population.

AstraZeneca's head of respiratory tells Scrip BORA Phase III data should reinforce and extend physician confidence in Fasenra as a long-term asthma biologic. The drug is also driving wider growth of biologics in asthma.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.