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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies Deals
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Companies

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Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy

The EU's CHMP has granted a positive opinion for Novartis' combo of MEK inhibitor Mekinist and BRAF inhibitor Tafinlar for BRAF-positive non-small cell lung cancer patients.

Approvals Commercial

UCB Predicts Briviact Sales Of €450m by 2026; Plans New Partnerships

UCB says its early to mid-stage pipeline contains 10 promising breakthrough molecules, some of which it aims to partner with other pharma players as part of its open innovation strategy.

Companies Sales & Earnings

Viking Flexes Its Muscles Ahead Of Partnering Talks

The mid-stage company is approaching Phase II data read outs for two lead assets. It is looking to partner with larger pharmas, but is also pursuing orphan indications that it could develop independently.

Business Strategies Rare Diseases

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll is moving on from leading the biotech industry body EuropaBio to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation on the agenda, Moll will have a lot of weighty dossiers to deal with.

Policy & Regulation Leadership

Ocular Therapeutix Gets Lead Product Back On Track

The long-acting eye insert Dextenza has been accepted for review by the US FDA, a piece of good news for Ocular Therapeutix that had previously received a complete response letter on manufacturing issues and a mixed bag of late-stage clinical trial results.

Companies Ophthalmic

Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

Approvals Biosimilars
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