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Approvals

Set Alert for Approvals

Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

Rare Diseases Launches

Pipeline Watch: Phase III Progress With BL-8040, Recorlev And Estelle

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

Alnylam Offers Flexible Value-Based Deals For Breakthrough RNAi Drug Onpattro

The commercial team is on board and ready to market the first FDA-approved RNAi therapeutic patisiran for hereditary transthyretin-mediated amyloidosis.

Rare Diseases Pharmacy Benefit Management

Pipeline Watch: Phase III Starts With Bavencio, MultiStem And VT-1161

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: Top-line Phase III Results For KX2-391, Dasotraline And Brigatinib

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

EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold

Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.

Biosimilars Commercial

Radius Braced For Second CHMP No For Abaloparatide

Another expected knockback by the European Medicines Agency's scientific committee is expected for Radius' lead product after the company revealed a negative trend vote for the osteoporosis therapy.

Approvals Policy & Regulation

AbbVie Prices Oral Endometriosis Drug Orilissa In Value Range, Focusing On Access

In addition to endometriosis, Orilissa (elagolix), developed by Neurocrine and licensed to Abbvie, is in Phase III for treating heavy bleeding associated with uterine fibroids.

Approvals Research & Development

Pipeline Watch: Phase III Progress With Roche's Baloxavir, Pfizer's Tanezumab And Takeda's Vedolizumab

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
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