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Policy & Regulation

New EU Approval Further Boost For Tagrisso As Threats Recede

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.

Approvals Clinical Trials Cancer

Vortioxetine Set For Japan Filing But Prospects Limited?

Positive results from a Japanese trial of Takeda/Lundbeck’s vortioxetine pave way for a planned approval filing in the country this year, but how might drug fare in the market?

Japan Research & Development Clinical Trials
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Policy

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Big Pharma Voluntary List Price Reductions Doubtful, Sen. Warren Says

Companies responding to inquiries from Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., did not indicate they are planning to reduce list prices, despite promises by President Trump, Warren told a June 12 hearing. 
Pricing Debate Pharmacy Benefit Management

BioMarin, Spark Hemophilia Gene Therapies Progress As Accelerated Approval Favors Their Indications

As updated Phase I/II results for BioMarin's hemophilia A and Spark's hemophilia B gene therapies were presented on May 22, it was revealed that FDA plans to make hemophilia the first gene therapy indication eligible for accelerated approval based on a surrogate endpoint.

Clinical Trials Drug Approval Standards

You Work In The Pharmaceutical Industry; Here's Why You Should Care About The Novartis Payments

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

Legal Issues Policy

A US Drug Pricing Rebellion Looms, Analyst Says

Wells Fargo analyst David Maris warned biopharma investors that the US drug market is on a long-term trajectory toward price controls, which he characterized as an under-appreciated risk for the sector, ahead of President Trump's speech on drug pricing.

Pricing Debate Pharmacy Benefit Management

Let's Make A Deal: Sanofi/Regeneron Extend A Hand On Praluent, Express Scripts Takes It

Express Scripts has agreed to give Praluent preferred access over Amgen's Repatha on its national formulary and is removing restrictions that have been a significant barrier to market access for the PCSK9 inhibitors.

Market Access Pricing Strategies

Lilly's Prices After Concessions Rise 6% In 2017, While Merck's Net Prices Decline

Price transparency reports from the big pharmas also show continued increases in price concessions in 2017, but a slow-down in list price increases.

Pricing Debate Pricing Strategies
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Regulation

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Latest From Regulation

Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology

Roche used its ASCO investor briefing to highlight its digital and personalized healthcare strategy, including examples of how it’s facilitating R&D and reimbursement – and how that should position it to be an oncology leader in the future. 

Digital Health ASCO

BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies

Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.

Regenerative Medicine Deals

Why Pharma Doesn't Always Keep Phase IV Promises In India

Are drug firms being lax when it comes to Phase IV studies in markets like India or are certain arbitrarily determined regulatory requirements largely to blame? Scrip delves into the issue.

Clinical Trials India

Novartis' Growth Driver Tafinlar/Mekinist Picks Up New Melanoma, Thyroid Indications

New FDA labeling brings Tafinlar/Mekinist into adjuvant melanoma setting, but Bristol's competing Opdivo already has captured nearly 50% of the market and is approved regardless of genetic mutation.

Approvals Clinical Trials

Synthetic Biologics’ Ribaxamase Setback Shows Difficulty Of C. Difficile Development

Company believes there is a path forward for developing ribaxamase in Phase III, based on discussions with the FDA, but deaths in Phase II meant loss of breakthrough designation.

Clinical Trials Drug Approval Standards

Modus CEO Says Rare Disease Priority Review Voucher To Be Key Catalyst

The US FDA gives Sweden's privately held Modus Therapeutics rare pediatric disease designation for sickle cell disease.

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