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Policy & Regulation

MolMed Pulls Zalmoxis Cell Therapy In EU

The Italian biotech will redirect investment, initially reserved for Zalmoxis, to other activities that would better meet its business objectives.

Europe Clinical Trials Approvals

Hengrui Halts Most Generic Development After Prices Free Fall In China

China’s favorite domestic drug maker seems to have a warning for the industry - innovate or halt. After the recent round of “4+7” centralized procurement saw some off-patent drugs priced at pennies, the leading Chinese firm Hengrui has decided to halve its generics portfolio to focus on innovative new drugs.

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Policy

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Latest From Policy

Drugs With ‘Unsupported Price Increases’ Add $5bn To US Spending – ICER

Pharmaceutical Research and Manufacturers of America describes report as “flawed” and designed to advance the “false narrative that spending on medicines in increasing.”

Pricing Debate Policy

UK Pilots 'Revolutionary And Needed' Antibiotic Payment System

The UK National Health Service is to test the world's first ‘subscription’ payment model to tempt drug makers to develop new products for resistant infections.

United Kingdom Government Payers

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

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

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
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Regulation

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Latest From Regulation

Biopharma Can Live With Boris’s Brexit Deal – But Will It Pass?

Industry would settle for UK Prime Minister Boris Johnson’s deal, with sweeteners promised for the sector.
United Kingdom Commercial

Mehta Analysis: What Can Tesla Teach Pharma?

The transformation of the automotive world has many lessons for biopharma, especially on the regulatory front, believes Viren Mehta of Mehta Partners.

Innovation Digital Health

Novartis Eyes Fourth Approval For Cosentyx

As Novartis files Cosentyx for non-radiographic axial spondyloarthritis, it is becoming increasingly clear that psoriasis will not be the blockbuster's revenue growth driver going forward.

Immune Disorders Strategy

Monkeypox Vaccine Approval A Shot In The Arm For Bavarian

Nigeria's monkeypox outbreak represents opportunity for Danish company still looking to overcome cancer vaccine setback.

Approvals Companies

Celltrion Will Sell World's First Subcutaneous Infliximab Directly In Europe

Celltrion has set out plans to market directly its subcutaneous version of infliximab in Europe. The firm has just received a nod that sets the stage for approval across the EU, albeit with more limited indications than the existing intravenous version.

 

Strategy Biosimilars

Pent-Up Demand As GW Pharma’s Epidyolex Approved In Europe

Drug will meet pent-up demand in Europe for clinically proven cannabis-based medicine for hard-to-treat epilepsy.

Europe Approvals
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