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.

Now valued at close to $3bn, Henlius is one of the largest biotech unicorns in China. CEO Scott Liu sat down with Scrip in an exclusive interview to discuss biosimilar development in China, emerging market expansion plans, and its venture into immuno-oncology combo strategy.

Market expansion services provider has its headquarters in Switzerland but a long history and most of its business in Southeast Asia, where the global head of its Business Unit Healthcare tells Scrip it continues to build a broad range of services based around knowledge and penetration of local markets.

Galera garnered $70m in Series C venture capital and $80m through a royalty deal tied to GC4419 and a follow-up drug for the treatment of severe oral mucositis caused by radiation therapy with an initial focus on head and neck cancer patients.

Clovis, CEO Patrick Mahaffy and former CFO Erie Mast will pay more than $20m to settle charges by the SEC that the company misled investors on the efficacy of rociletinib. Clovis raised $298m in a public stock offering during the timeframe SEC says it misled investors.

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.

Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.

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.

Spectrum is expanding a clinical trial with its novel, oral pan-HER inhibitor poziotinib into the first-line treatment of NSCLC with EGFR or HER2 exon 20 insertion mutations, which could provide a much-needed new option for these patients. The move also marks further positive development progress for the drug, which the US firm licensed in from Hanmi.

Two Asia-based companies disclose delays to important clinical pipeline assets, one in oncology driven by apparent ethnic differences in response to prior therapy and the other a CNS molecule hit by an unexpected toxicity finding in an animal study.