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Policy & Regulation

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory Committees Drug Review Neurology

Bruised Roche Wins Another UK Perjeta Round With Price Cut

In the latest round of what appears to have been a bruising set of price negotiations for Roche, the UK’s cost effectiveness agency NICE has recommended Perjeta in another breast cancer setting.

United Kingdom Cancer Market Access
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Policy

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Latest From Policy

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Commercial

No More Rebates: HHS Proposed Rule Revises Anti-Kickback Safe Harbor

Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of sale and the other protecting flat service fees paid by manufacturers to pharmacy benefit managers. But rebates to "PBMs to buy formulary position" in Medicare/Medicaid would lose protection.

Pricing Strategies Pharmacy Benefit Management

Generic Advair: Finally Approved, A Long Time Coming

Mylan's generic version of GlaxoSmithKline's blockbuster asthma drug was approved by the US FDA Jan. 30. Scrip's timeline tracks how the commercial value of the drug for GSK has greatly declined from its peak in 2013.

Approvals Generic Drugs

Innovation The Centerpiece In Mixed Japan 2019 Outlook

2019 has already brought one industry-shaking event in Japan with the formal completion of the Takeda-Shire deal. But how will this play out and what else can we expect in this key market over the next year?

Japan Commercial

US Drug Pricing: What A Difference A Year Makes

Drug makers were optimistic going into 2018 about the political climate and drug pricing environment, but the outlook is more tenuous heading into 2019. Now is the time when industry raises prices on mature, marketed drugs and it's unclear how those hikes may be tempered or what the backlash might be.

Pricing Debate Pricing Strategies

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
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Regulation

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Latest From Regulation

Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

FDA Immune Disorders

AZ And Ipsen Outline Brexit Contingency Plans

With the UK no nearer to deciding how hard or soft its exit from the EU will be on March 29, AstraZeneca and Ipsen have given updates on their efforts to cope with the chaos that could ensue on the medicines supply front.

United Kingdom Brexit

Infographic: The Netherlands, A Small Country With Big Ideas

As the EMA lowers the flags of the 28 EU nations that have flown outside its London offices for 24 years, and prepares to moves its HQ to the Netherlands, Scrip takes a look at Europe’s new pharma regulatory hub.

Europe Policy & Regulation

In A Record Year For US FDA Approvals, Pfizer Came Out On Top

FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders. 
Approvals Drug Review

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

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
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