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Approvals

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 Vaccines
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Approvals

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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

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

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

Pipeline Watch: Kisqali, SI-6603, Cosentyx Phase III Readouts

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
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