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Approvals

LEO Pharma Gets EU Go-Ahead For Psoriasis Latecomer Brodalumab

The Danish speciality dermatology company LEO Pharma has achieved a key plank in its plans to provide products for the range of psoriasis patients with an EU go-ahead for brodalumab.

Drug Review Approvals Dermatology
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Pipeline Watch: Top-Line Ozanimod, Romosozumab, Cariprazine Phase III Results

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

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Pipeline Watch: Top-Line Lanadelumab, Inotersen, Durvalumab Results

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

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory

Pipeline Watch: Phase III Starts With Simvastatin, AR101 And Brexanolone

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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