Glenmark expects its first US manufacturing site to go commercial next year, accelerating growth in that market, while it sets right certain compliance blips back home. The Indian firm is also on course to divest certain non-core assets but notes that bringing in a minority partner for its API unit is not a priority.

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s elafibranor, and Albireo thinks IBAT inhibition offers promise in NASH.

With gender diversity only slowly increasing in biopharma c-suites, Scrip spoke to executives from five companies about the importance of change.

As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes down investment by $37.5m causing Q2 profits to slump 74%. Post successful Phase II trials in the US for NASH and NAFLD indications, its hopes are now pinned on saroglitazar magnesium.

UK pharma giant’s head, International tells Scrip expanded alliance with diversified Japan group will develop solutions across the patient journey, while new China investments aim to tap into emerging innovation in this market.

The first country ever to approve a gene therapy, China has been lagging in the area since due to a lack of clear regulatory pathways and insufficient financial incentives. Now a new crop of developers are aiming to revitalize ambitions and make the country a major power for promising novel treatments for rare neurodegenerative conditions, retinal dystrophy, HIV and cancer.

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

Zealand Pharma’s recently installed CEO says it is building US operations to prepare for four potential approvals there in 2020, with commercial launches starting in 2021, its first ever.

The frontrunner in hemophilia A gene therapy has been hit by data doubts, but this and achondroplasia drug could deliver in 2020.