With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.

Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.

Heading into Phase III in 2019 is Lilly's dual agonist of GLP-1 and GIP, which has shown notable therapeutic effects on blood sugar and body weight in type 2 diabetics in a mid-stage clinical study. Meanwhile Lilly/Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, is being discussed with regulators with regard to its use in type 1 diabetics, an additional indication, following the release of full results from the EASE Phase III program.

CEO Craig Wheeler talked to Scrip about the challenging biosimilar market dynamics and the company's decision to end most biosimilar drug development. The path to value creation in biosimilars is not clear, he said.

Vertex is set to reap huge benefits from its triple combination program for cystic fibrosis over the next 10 years, potentially becoming the biggest selling drug in this disease, according to a new report from Datamonitor Healthcare.

Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease.

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.

Botox was a game-changer, which means challengers to Allergan's blockbuster are on the way. Dermal fillers and devices also have an important role, but dermatologists say innovation is needed to fill treatment gaps. Business development is ongoing to expand companies' product portfolios.

Medical aesthetics is a growing, but largely untapped biopharma niche with unique consumer marketing and doctor relationship-building strategies where key players have honed their skills for many years. Allergan's blockbuster Botox dominates, but competitors are gaining ground.