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Approvals

Roche's Hemlibra Priced And Labeled To Beat Competition, Safety Concern

Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.

Approvals Blood & Coagulation Disorders Pricing Strategies
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TiGenix CEO Confident Of European Green Light For Lead Asset

TiGenix CEO Eduardo Bravo outlines group's commercialization plans for CPF candidate Cx601 in Europe and the US.

Approvals Business Strategies

Samsung's Ontruzant Becomes First Trastuzumab Biosimilar Approved In EU

Samsung Bioepis is poised to grab the leading position in the trastuzumab biosimilar market in Europe as its biosimilar Ontruzant gets the European Commission's approval ahead of the competition.

Biosimilars EU

Pipeline Watch: LentiGlobin, BMS-986205 Phase III Studies Initiated

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

GSK's Triple Combo COPD Drug Gets Europe Okay

Europe's regulators have followed their US counterparts and given the green light to GSK's Trelegy. Now the company is hoping that having the first once-daily single inhaler triple therapy for COPD will boost its respiratory business.

Respiratory Approvals

AZ Looks To Lead Severe Asthma Market After US Fasenra OK

Following FDA approval, AstraZeneca believes that despite reaching the market after GlaxoSmithKline’s Nucala and Teva’s Cinqair, Fasenra's strong clinical package, convenient dosing and very competitive pricing will make it the leading biologic for severe asthma.

Respiratory Approvals

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
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