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Policy & Regulation

Sanofi/Regeneron Choose Access Over Price With Dupixent Launch

The FDA approved the IL-4/IL-13 inhibitor March 28 in a win for Sanofi and Regeneron. The companies set the biologic's price at $37,000 per year, which is lower than many biologics on the market for psoriasis.

Launches Approvals Pricing Strategies

Broad Label Gives Tesaro's Niraparib A Head Start In Ovarian Cancer

Tesaro takes opportunity of broad approval for Zejula (niraparib) in recurrent ovarian cancer to highlight franchise expansion opportunities in other tumor types, including PD-1 inhibitor combination studies.

Approvals Clinical Trials Cancer
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Policy

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Latest From Policy

Pfizer On Obamacare Rewind: No Short-Term Impact On Industry

Pfizer CEO Ian Read explains why industry has stayed on the sidelines during the current health reform debate and defends drug pricing practices during a speech to the National Press Club.

Policy Pricing Debate

Which Pharma Firm Increases US Prices The Most?

Transparency reports from companies aim to change conversation from prices to discounts, but also invite comparisons. Lilly, for example, saw a higher average list price increase in 2016 than Merck and Janssen, but its net prices grew by less than the others.

Pricing Debate Policy

US Insulin Pricing Probe Clouds Prospects for Novo Nordisk, Others

As US prosecutors investigate Novo Nordisk and other insulin makers for their pricing and contracts with pharmacy benefit managers, plaintiff firms allege the Danish group engaged in collusive agreements and misled investors about its earnings and forecasts.

BioPharmaceutical Policy

NICE Appraisal Changes: A New Pricing Hurdle For Companies

New NICE and NHS England appraisal rules regarding timelines and price thresholds – labeled stark and contradictory – could fast-track new cost-effective drugs but then subject the same products to significant delays of multiple years.

Pricing Strategies United Kingdom

Why Is Drug Pricing Higher In US? Study Takes Aim At R&D Argument

Amgen, Biogen, Pfizer and Teva generated more than twice their global R&D budgets with higher pricing in the US compared to Western Europe and Canada, researchers at Memorial Sloan Kettering found.

Pricing Debate Pricing Strategies

Brexit And International Reference Pricing To Cost Companies Billions Of Dollars

Companies could lose hundreds of millions of dollars thanks to the impact of Brexit on international reference pricing. Brexit has other market access implications too, for example on the ebb and flow of parallel trade.

Brexit Market Access
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Regulation

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Latest From Regulation

Misery In Myelofibrosis: Pacritinib Setback A Boost For Jakafi

With the commercial opportunity in the myelofibrosis market expected to double to over $1bn in the next five years, competition to Incyte/Novartis's Jakafi seems further away than ever as CTI BioPharma pulls the European regulatory filing for pacritinib.

Research & Development Regulation

Purdue Highlights Convenience Of New Opioid Induced Constipation Drug Symproic

With oral naldemedine joining Purdue's pain portfolio, the company will look for ways to foster communication between patients and doctors about treatment for opioid-induced constipation.

Approvals Clinical Trials

Pfizer's Avelumab Makes Its Debut, In Rare Form Of Skin Cancer

Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.

Approvals ImmunoOncology

Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month

First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.

Approvals Regulation

Biogen Secures First-Round Patent Win For Tecfidera; One More To Go

PTAB rejected an inter partes review challenge to a key patent protecting the oral multiple sclerosis blockbuster to 2028 in the US, but another challenge remains outstanding.

Intellectual Property Legal Issues

Now Is The Time! Rule Changes To Open Up China To Foreign New Drugs?

The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to bolster multinationals’ interest and activity in China, and to quicken the pace of launches to potentially overcome the country’s “drug lag”.

China Drug Approval Standards
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