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Policy & Regulation

Drug Price Waterloo: China's New Bidding Process Hits MNCs Hard

China's new so-called “4+7” drug bidding pilot scheme, already expected to be a killer for some companies, has cut prices by as much as 90%, leaving all but two multinationals to bid successfully and accept the revised levels. The big reductions could also lead to further price erosion for the winning products.

China Commercial Government Payers

UK Receives £1bn Confidence Boost From Industry Investment In Life Sciences Sector

The international biopharma industry is backing the UK life sciences sector, with UCB spearheading the charge with a £1bn commitment to R&D in the nation still in a state of flux regarding its exit from the European Union in 2019.

United Kingdom Deals Innovation
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Policy

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Latest From Policy

Pharma: Be Prepared For Tougher Price Negotiations For IO Combos And Expansions In Europe

Payers are increasingly likely to implement new strategies to manage price negotiations for immuno-oncology combinations, as competition  heats up among the drug class. Mechanisms allowing for the negotiation of different prices for combination therapies do not exist at present, but payers insist that new tools must emerge.

ImmunoOncology Health Technology Assessment

Lilly CEO Made New IFPMA President On Health Budget Mandate

David Ricks will lead IFPMA into 2020 with an eye on how to meet the healthcare needs of the world’s aging population, and stepping up the power of private-public partnerships.

International Leadership

Medical Research Council Hopes To Build On UK / China AMR R&D Collaborations

Financial grants are bringing UK and Chinese researchers together in bilateral collaborations to fight the growing global threat from antimicrobial resistance.

Infectious Diseases Emerging Markets

No, It's Not Just Out-Of-Pocket Costs That Are A Problem, John Arnold Tells Pharma

The billionaire philanthropist and industry agitator took the stage at the Forbes Healthcare Summit to discuss why his foundation is focused on fixing drug pricing and supporting organizations like ICER and Patients for Affordable Drugs.

Pricing Strategies Policy

Industry Wants US Rebate Reform, But What Does That Mean?

Drug makers are bracing for a potential new policy change around rebating that could change the way they price drugs and negotiate market access. But some in the industry are advocating for a less disruptive new discounting system over the elimination of rebates all together.

Pricing Debate Reimbursement

Amgen Drops Repatha List Price 60% To Cut Medicare Co-Pays And Boost Use

Company says 75% of Medicare Part D patients who aren't eligible for low income subsidies abandon the PCSK9 inhibitor at the pharmacy counter due to $370 co-pay, which may now range from $25-$150 per dose.

Pricing Strategies Market Access
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Regulation

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Latest From Regulation

Luxturna Approved In EU: Novartis Outlines Lessons For Gene Therapy Strategies

The European Commission has officially approved Luxturna, Novartis/Spark Therapeutics’ transformative gene therapy. The Swiss firm tells Scrip how the lessons it expects to learn from launching its first gene therapy will inform its future strategy in this new field.

Innovation Approvals

Vertex Secures Hat Trick Of Europe CF Approvals With Nod For Symkevi

Now that the EMA has followed its US counterpart in granting approval for its cystic fibrosis drug Symkevi, Vertex will once again have to navigate Europe's various reimbursement systems, with observers keeping a close eye on how talks with NICE go.

Approvals Reimbursement

Genentech, Amgen Face Big Impact From Part B International Pricing Index

Medicare spending on Genentech’s Rituxan and Lucentis, and Amgen’s Neulasta and Prolia/Xgeva, would have been $3.8bn less in 2016 using the proposed international pricing index model, CMS estimates.

Pricing Debate Medicare

Esperion Expects Preferred Formulary Placement For Oral Cholesterol Drug Bempedoic Acid

Final Phase III study for pivotal package of cholesterol drug bempedoic acid shows LDL-lowering efficacy and a clean safety profile, paving the way for filings in the first half of 2019.

Cardiovascular Research & Development

Diabetes Drug CV Outcomes Trials May Be Needed For Market Success But Not Approval, US FDA Panel Says

Longer, broader premarketing trials should replace the requirement for dedicated outcomes trials to demonstrate CV safety, but competitive pressure may drive sponsors to voluntarily conduct outcomes studies to demonstrate CV benefit, FDA advisory committee members said.

Advisory Committees Drug Approval Standards

Every Little Helps: Shire Product Advances Fortify Takeda's Bid

A positive opinion in the EU for Shire's Takhzyro and a favorable US advisory committee vote for prucalopride are incremental positives for Takeda's planned acquisition, on which shareholders are likely to vote in the coming weeks.

Advisory Committees Approvals
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