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Approvals

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Novo Nordisk's Ultra-Fast Acting Insulin Cleared For Pediatric Use In EU

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

 

Metabolic Disorders Approvals

Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Infectious Diseases Approvals

Pipeline Watch: Phase III Results With Osimertinib, Ripretinib And Evinacumab

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

Inrebic Approval Is A Boost For Myelofibrosis And Celgene's Buyer Bristol

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Approvals Cancer

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Europe's Biotechs Gathering Steam With Filgotinib Filing

Galapagos is another step closer to commercializing its products with its lead candidate, filgotinib, now under the gaze of EU regulators.

Approvals Inflammation

Roche/Genentech Set Lower Rozlytrek Price To Catch Up With Bayer’s Vitrakvi

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

Approvals Personalized Medicine

Pipeline Watch: Phase II/III Readouts For Setmelanotide, Ceftobiprole And Olaparib

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 Pipeline Watch

Getting A Good Start: Sanofi Extends Dupixent's Potential To Younger Patients

Sanofi/Regeneron’s pioneering biologic, dupilumab, is growing its potential market before the advent of competing molecules. An EU approval extension, allowing use in adolescents as well as in adults, and positive Phase III results in children aged six to 11 years with severe atopic dermatitis, should help.

Dermatology Approvals
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