A review of second quarter biopharma start-up deal-making and financing activity from Strategic Transactions showed a quarter-over-quarter drop in dollars raised despite multiple mega-rounds, including $100m-plus VC deals for SpringWorks and Fusion.

Imbruvica is keeping ahead of potential competitors in Europe by expanding its use in patients with chronic lymphocytic leukemia and Waldenström’s macroglobulinemia.

While deal-making in the Asian pharma space shows no signs of slowing down, the past few months have been marked by a series of high-profile cases involving the return of rights by licensees or setbacks in clinical trials. Scrip's regional team looks at some of the factors at work.

Patient numbers and prescriptions in the US for Sun’s psoriasis therapy Ilumya are steadily on the rise, and the Indian firm said that the arrival of AbbVie’s rival Skyrizi hasn’t adversely impacted its formulary position.

The big pharma could not confirm whether AveXis co-founder and CSO Brian Kaspar and his brother, SVP of R&D Allan Kaspar, were fired. Instead, Novartis noted that the withholding of preclinical safety data for Zolgensma was limited to the action of a few employees. NIBR preclinical safety chief takes key role at AveXis

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

The trial linked ANGPTL3 antibody evinacumab to a steep decline in LDL cholesterol in patients with homozygous familial hypercholesterolemia, setting Regeneron up to file for US FDA approval next year.

Lundbeck highlighted R&D and the strong growth of four strategic products in the first half, as revenues were hit by generic competitors to top-selling products.

The PAOLA-1 study has shown the benefit of Lynparza for ovarian cancer patients regardless of tumor mutation status which should firm up the drug's dominance in the PARP inhibitor space.