Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

New models of paying for gene therapies will emerge as more of these innovative treatments, particularly outside the rare disease and oncology spaces, hit the market.

Sector wants R&D tax credits updated, investment in Biomedical Catalyst, and is dismayed by spending delay. 

Critics of the government's decision to suspend parliament for five weeks say it will make a no-deal Brexit more likely – a prospect that the life sciences industry is particularly worried about.

Delaware district court rules patent claims for antibodies targeting PCSK9 are invalid for lack of enablement; saga to continue with Amgen appeal.

The updated business principles may give pharma companies leverage, or at least talking points, as they continue to engage with the Trump administration on policies like the International Pricing Index and with US lawmakers on drug pricing legislation. J&J's Gorsky heads governing committee of multi-industry business group that revised its principles.

Novartis/Spark’s gene therapy Luxturna has been OKd for NHS use by NICE in record time thanks to early engagement and close collaboration between the two parties. 

Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.

Sir Andrew Dillon is leaving his role as CEO of England’s health technology assessment body after 20 years.

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.