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Latest From Review Pathway

What We Talk About When We Talk About Confirmatory Evidence

Meaning of 'confirmatory evidence' becomes review issue in some of US FDA's most difficult choices: when a drug for a significant unmet medical need is supported by a single inadequate – but not failed – clinical trial. Neurology division director Dunn and review team leader Marler explain their interpretations in Ocrevus review memos.

Review Pathway Drug Review Profile

Multiple Sclerosis Subtype 'Relatedness' Drove Debate On Ocrevus Approval

Genentech's Ocrevus BLA set off internal US FDA dispute about relationship between different subgroups of disease: Can strong evidence in one form (relapsing MS) confirm a weak study in another (primary progressive MS)? Our Drug Review Profile looks at how FDA rationalized approval of Ocrevus for PPMS.

Drug Review Profile Drug Approval Standards

Australian Notification System To Help Sponsors Make Low-Risk Variations Faster

New guidance from the Therapeutic Goods Administration clarifies which changes sponsors will be able to make to their registered medicinal products using Australia’s forthcoming notification system.

Regulation Review Pathway

Loxo Sees Larotrectinib As Model Form Of Oncology Drug Development

The pivotal data presented at ASCO showed a 76% response rate for the TRK inhibitor in patients with TRK fusion abnormalities, but there's still a lot left to prove about the tissue-agnostic model of drug development.

Cancer Clinical Trials

Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella

Merck's Keytruda may not be only oncologic with indication for cancer patients defined by molecular signature, not tissue of origin, for long: Ignyta's entrectinib and Loxo Oncology's larotrectinib are positioned for breakthrough-designated tissue-agnostic NDA submissions in NTRK fusion-positive cancers in 2018.

Cancer Approvals

Chronic Hepatitis D Among Targets Of Latest Drugs On EMA’s PRIME Scheme

The latest five products to make it onto the European Medicines Agency’s priority medicines (PRIME) scheme for products target a number of areas of unmet medical need.

Europe Regulation

Getting On – And Staying In – the EMA’s PRIME Scheme

Companies won’t necessarily lose their place on the European Medicines Agency’s priority medicines scheme if a competing product gets to market first. And they shouldn’t be put off by the fact that competing products are already on the scheme.

Europe Regulation

EMA’s PRIME A Year On: Hits And Misses When It Comes To Applications

Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.

Review Pathway Regulation

Why Still Nothing For AMR? EMA Asks PRIME Scheme Applicants

The European Medicines Agency wants AMR drug developers to apply for entry on its priority medicine (PRIME) scheme.

Europe Regulation
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