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Approvals

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Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes

Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies. 

Approvals Blood & Coagulation Disorders

Pipeline Watch: Phase III Starts In Prostate Cancer, C Diff Diarrhea

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

Old Dog, New Tricks: Label Expansions Invigorate Diabetic Nephropathy Market

With four new entrants readying to be prescribed in the next four years, the market for diabetic nephropathy is looking more buoyant than ever. However, competition from GLP-1 agonists and eventually from generics could put a dampener on proceedings.

 

Metabolic Disorders Renal

New Option For Uncontrolled Epilepsy On Horizon As US Accepts Cenobamate NDA

New potentially effective therapy for drug-resistant epilepsy, seen as the most pressing unmet need in this market, is on the horizon as FDA begins approval review of SK’s cenobamate, also marking a first for the Korean pharma industry.

United States Approvals

Pipeline Watch: Top-Line Phase III Results With Isatuximab, Margetuximab

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

With Jeuveau Approval, Evolus Will Focus On The Beauty Business To Gain Market Share

Evolus believes its focus on the beauty business will be a differentiator for its neurotoxin Jeuveau. The company will publish head-to-head results against Botox alongside the Spring 2019 launch and does not expect a new trade secrets complaint from Botox maker Allergan to delay its product.

Approvals Launches

Pipeline Watch: Top-Line Phase III Results For Tanezumab, Dengue Vaccine, Ibrexafungerp

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

Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.

Approvals Business Strategies

Generic Advair: Finally Approved, A Long Time Coming

Mylan's generic version of GlaxoSmithKline's blockbuster asthma drug was approved by the US FDA Jan. 30. Scrip's timeline tracks how the commercial value of the drug for GSK has greatly declined from its peak in 2013.

Approvals Generic Drugs
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