The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

ViiV CEO predicts strong pipeline and two-drug strategy will reinforces group's HIV market position and put it ahead of Gilead by the mid-2020s.

Switching patients from the very expensive ultra rare disorder drug to ravulizumab will be a key strategy for Alexion if the latter is approved. Recent compelling data in paroxysmal nocturnal hemoglobinuria patients suggests the long-acting C5 complement inhibitor could offer more benefit than its predecessor with more convenient dosing.

Among other debates at the American Diabetes Association annual meeting, clinicians will discuss the future of cardiovascular outcomes studies for diabetes drugs – whether they should maintain course or are due for an overhaul.

Kala Pharmaceuticals is hoping to shake up the dry eye market with a NDA filing this year for its steroid eye drop KPI-121 0.25%.

An oversubscribed financing round led by new US investor MPM Capital has brought in $75m for the Belgian company. Much of it will be used to advance its potential best-in-class adenosine A2A receptor now that its IDO1 drug has been shelved.

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.

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.

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.

Tagrisso's march on the first-line EGFRm NSCLC market looks like it will be unimpeded by any near-term rivals following new data at ASCO as the EU becomes the latest market to approve it in the first-line setting.

Lilly priced its now-approved Olumiant (baricitinib) to fight for US market share versus well-known rheumatoid arthritis therapies, undercutting Humira by 60% and Pfizer's established JAK inhibitor Xeljanz by 50%.

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.

The FXR agonist is the first new drug approved for primary biliary cholangitis in 19 years, but the lack of long-term outcomes data leaves a perceived opportunity for a host of mid-stage candidates also pursuing the indication. Intercept is conducting a Phase IV study to obtain such data with Ocaliva.