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Approvals

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Janssen's Tremfya Gains Psoriatic Arthritis Indication In EU

The European Commission has extended the indications for Janssen’s Tremfya to include psoriatic arthritis, and those for BMS’s Opdivo to include gastroesophageal cancer.

Cancer Approvals

Alnylam Turns To Value-Based Pricing Again For Oxlumo

As with its first two approved RNAi therapies, Alnylam will negotiate value-based agreements with payers, but for Oxlumo, approved in pediatric patients, it will offer a patient need adjustment.

Approvals Pricing Strategies

Lilly Gets Second EUA, For Baricitinib In COVID-19 Patients

Weeks after FDA authorized emergency use of its antibody bamlanivimab, Lilly’s RA drug Olumiant can be used to shorten recovery time for hospitalized COVID-19 patients in the US. Authorizations are being pursued elsewhere as well.

Coronavirus COVID-19 Approvals

Pipeline Watch: Phase III Readouts In Liver Diseases, COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals 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 Readouts For Xeljanz, Octagam And Nefecon

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals 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 Starts In Alopecia, MS-Associated Spasticity And Dyskinesia

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals 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 Starts In Huntington's Disease, COVID-19, Head And Neck Cancer

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals 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

Positive Atopic Dermatitis Data On Lilly's Newly-Approved Olumiant

It has gone under the radar that Eli Lilly and Incyte's Olumiant has recently become the first JAK inhibitor to be approved anywhere for atopic dermatitis and the companies have been touting promising long-term data on the therapy as it expands beyond rheumatoid arthritis.  

Approvals Immune Disorders

Pipeline Watch: Late-Stage Candidate Bacterial And Viral Vaccines Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals 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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