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Approvals

New EU Approval Further Boost For Tagrisso As Threats Recede

Tagrisso's march on the first-line EGFRm NSCLC market looks like it will be unimpeded by any near-term rivals following new data at ASCO as the EU becomes the latest market to approve it in the first-line setting.

Approvals Clinical Trials Cancer
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Opdivo Approval Opens China I-O Doors But Pricing Key

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

China Cancer

Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction

Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.

Generic Drugs Approvals

Pipeline Watch Phase III Progress With Trintellix, Ocrevus And Olumiant

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

Pipeline Watch: Phase III Progress With Nimotuzumab, Solriamfetol, And Upadacitinib

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.

 

Approvals Research & Development

Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose

Lilly priced its now-approved Olumiant (baricitinib) to fight for US market share versus well-known rheumatoid arthritis therapies, undercutting Humira by 60% and Pfizer's established JAK inhibitor Xeljanz by 50%.

Approvals Pricing Strategies

Novartis To Ape Aimovig's US Market Strategy In The EU As CHMP Gives Market Go-Ahead

Swiftly following its first approval in the US, Amgen/Novartis' Aimovig has just been given a CHMP go-ahead in the EU positioning it to be the first CGRP targeting agent on the market there. Launch tactics look set to mirror those in the US.

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