Astellas becomes first to market in Japan in new class of oral anemia drugs, beating multiple rivals in a sector set to see strong growth but also fierce competition.

Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

Pharma’s digital spend is expected to spurt in the coming years and firms are deploying a range of initiatives to deliver personalized content to physicians via preferred channels. KOL webinars feature among the top three approaches for marketers across the Americas, Europe and Asia, a new survey shows.

One of a new wave of treatments, Novartis has focused on proving its drug cuts vaso-occlusive crises (VOCs), or pain crises.

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.

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.

Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.

Karuna Therapeutics’ top-line Phase II data for a combination of a centrally acting muscarinic agonist, xanomeline, and a peripherally acting muscarinic antagonist, trospium, were greeted with enthusiasm by investors and the Boston, MA-based biotech.