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Policy & Regulation

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy Drug Safety

AZ, Novartis, Roche Take Part In UK’s Big Data Push

Seven hubs will bring together data sets and help accelerate clinical trials.

 

 

Digital Health United Kingdom Clinical Trials
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Policy

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Latest From Policy

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

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.

Legal Issues Policy

How To Pay For The New Wave Of Gene Therapies

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.

Health Technology Assessment Government Payers

Amid Brexit Chaos, UK Defers Life Sciences Spending Commitments

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

United Kingdom Brexit

UK Parliament Suspension Could Make No-Deal Brexit More Likely

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.

United Kingdom Brexit

After Two Jury Verdicts, Court Finds Repatha Patents Invalid

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

Cardiovascular Legal Issues

In Search Of Goodwill, Several Pharmas Commit To New Corporate ‘Statement Of Purpose’

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.

Pricing Debate Policy
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Regulation

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Latest From Regulation

Novartis Prepares for UK Luxturna Rollout After Rapid NICE OK

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. 

United Kingdom Health Technology Assessment

Vascepa Included In European Dyslipidemia Guidelines Ahead Of Approval

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.

Cardiovascular Regulation

NICE Head Sir Andrew Dillon To Stand Down

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

United Kingdom Health Technology Assessment

Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

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.

Infectious Diseases Approvals

Vanda Not Ready To Give Up On Jet Lag Indication For Hetlioz Despite CRL

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.

Commercial Life Cycle Management

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

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.

Approvals Business Strategies
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