Fosmetpantotenate missed all endpoints in a Phase III trial, so Retrophin will shelve the candidate for the rare disease PKAN. Now, the biotech turns focus to Phase III sparsentan in a pair of indications.

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

The synthetic biotics company is discontinuing development of SNYB1020, its first clinical-stage product, which failed to lower blood ammonia in cirrhosis patients.

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

The primary endpoint was missed in a Phase IIa study of Oxurion’s THR-317 in diabetic macular edema, but vision did improve in two patient subgroups.

AstraZeneca’s SGLT2 inhibitor has grabbed attention for its potential role in chronic heart failure patients, with or without type 2 diabetes, following initial results from the DAPA-HF study.

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

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.

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Galapagos is another step closer to commercializing its products with its lead candidate, filgotinib, now under the gaze of EU regulators.

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.

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.