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Policy & Regulation

FDA Approves First Digital Pill: Otsuka/Proteus' Abilify MyCite

Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.

Approvals Digital Health Neurology

EU CHMP OKs New Treatments For MS, Esophagitis, CMV, Hemophilia – & First Biosimilar Avastin

The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.

Drug Review Approvals Europe


Set Alert for Policy

Latest From Policy

$1M For Luxturna? ICER Says Big Discount Needed To Be Cost Effective

Luxturna, a one-time treatment for a rare inherited form of blindness, would not be cost-effective at the $1m price level that has been suggested as a possibility, based on ICER's thresholds. But the small patient population would keep it from triggering ICER's US budget spending threshold.

Reimbursement Pricing Strategies

Mehta Analysis: The Tangled Web Of PBMs

Pharmacy Benefit Managers are a key part of the medicines market in the US, but their role is complex. Viren Mehta, founding partner of Mehta Partners, LLC considers how their business model has evolved over the years, where it is headed, and how PBMs impact others in the healthcare ecosystem.

Pharmacy Benefit Management Policy

Opdivo Use For Urothelial Cancer Blocked By NICE In Draft Guidance

Opdivo has failed to convince the UK's pricing watchdog, NICE, of its value and benefit for patients with advanced urothelial cancer; in its draft decision the reimbursement body has also rejected the drug for use on the Cancer Drugs Fund.

Market Access Cancer

Smooth AdCom Passage Expected For Novo's Semaglutide Despite Retinopathy Queries

Novo Nordisk's Victoza follow-on semaglutide, forecast to become the third once-weekly GLP-1 product available on the highly competitive US diabetes market, is expected to secure a market-leading spot, by revenue, before 2025.

Metabolic Disorders Advisory Committees

Medifron Move Signals Alzheimer’s R&D Acceleration In Korea

Medifron DBT's plan to make a sizable investment in its Alzheimer’s disease drug pipelines may be followed by further South Korean biotechs and pharmas accelerating development in the field as the country steps up support for dementia R&D.

South Korea Financing

Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps

Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.

Reimbursement Advisory Committees
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Set Alert for Regulation

Latest From Regulation

Amsterdam wins European Medicines Agency After Milan Loses Coin Toss In Tight Race

London has lost the European Medicines Agency to Amsterdam after the Dutch capital beat Milan in a voting process that ended in the drawing of lots. The Italian pharmaceutical industry was understandably disappointed at losing, but the EMA said the decision “ticked a lot of our boxes” and would help to keep down staff losses and ensure business continuity.

Brexit Regulation

Political Bargaining Intensifies Before Vote On EMA’s New Home

In the run-up to Monday’s vote on the EMA’s future home, political horse-trading and vote-swapping behind the scenes makes it difficult to predict which EU city will win the prized agency.

Brexit Regulation

Ultragenyx Gets Commercial Feet Wet With Mepsevii Launch In Sly Syndrome

Commercial opportunity for Mepsevii is small, but launch paves way for company's second product burosumab, following on its heels.

Launches Commercial

Heplisav-B Approval Has Dynavax Going It Alone On US Launch In Early 2018

Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.

Approvals Launches

New US Indication May Help Finally Get Keryx' Auryxia Off The Ground

Company plans to use the same sales force and broad insurance coverage for oral iron product in new use for CKD patients with iron deficiency anemia not on dialysis, as for the first approved use in dialysis patients, so it will "hit the ground running."

Approvals Blood & Coagulation Disorders

UK To Offer Firms More Flexible Commercial Deals On ‘Transformative’ Drugs, Earlier Access To Market

Companies seeking to have their innovative drugs made available on the NHS in England could benefit from government plans to offer “transformative” new products access to the market up to four years earlier than under the standard assessment route.

Market Access Innovation
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