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Shire PLC (SHPG.OQ)

SHPG.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Novimmune and Shire sign license agreement deepening bispecific antibody research collaboration​
Tuesday, 18 Jul 2017 07:00am EDT 

July 18 (Reuters) - NOVIMMUNE SA ::‍NOVIMMUNE AND SHIRE SIGN LICENSE AGREEMENT DEEPENING BISPECIFIC ANTIBODY RESEARCH COLLABORATION​.  Full Article

Shire submits IND application for gene therapy candidate SHP654
Thursday, 6 Jul 2017 07:01am EDT 

July 6 (Reuters) - Shire Plc :Shire submits investigational new drug application to FDA for gene therapy candidate SHP654 for treatment of Hemophilia A.Shire Plc - Shire submits investigational new drug application to FDA for gene therapy candidate SHP654 for treatment of Hemophilia A.  Full Article

Shire says EMA Validation of Veyvondi
Thursday, 22 Jun 2017 01:00am EDT 

June 22 (Reuters) - Shire Plc ::Announced that European Medicines Agency validated marketing authorization application for Veyvondi.  Full Article

Supernus says Shire receives FDA approval for Mydayis for ADHD
Wednesday, 21 Jun 2017 12:37pm EDT 

June 21 (Reuters) - Supernus Pharmaceuticals Inc ::Supernus announces that its partner Shire receives FDA approval for Mydayis™ for ADHD.Shire expects to make Mydayis commercially available in United States in Q3 of 2017.Based on agreement between Supernus, Shire, Shire will pay to Supernus single digit percentage royalty on net sales of product.  Full Article

Kamada receives additional milestone payment under Glassia exclusive supply and distribution agreement with Shire
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Kamada Ltd :Kamada receives additional milestone payment under glassia® exclusive supply and distribution agreement with shire.Kamada receives additional milestone payment under glassia® exclusive supply and distribution agreement with shire.Kamada Ltd - milestone payment was triggered by shire achieving a sales milestone for glassia in u.s.Kamada Ltd - recently shipped all of proprietary products-related revenues, totaling approximately $11.5 million, which were previously delayed from q1.Kamada Ltd - as detailed by kamada in its q1 financial results, revenues from shipment were shifted from q1 and will be recorded in q2.Kamada Ltd - announced receipt of an undisclosed additional milestone payment under supply and distribution agreement with shire for glassia.  Full Article

Kamada receives additional milestone payment from Shire PLC
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Kamada Ltd :Kamada receives additional milestone payment under Glassia exclusive supply and distribution agreement with Shire.Kamada Ltd - announced receipt of an undisclosed additional milestone payment under supply and distribution agreement with shire for Glassia.Kamada Ltd - milestone payment was triggered by shire achieving a sales milestone for Glassia in U.S..Kamada Ltd - recently shipped all of proprietary products-related revenues, totaling approximately $11.5 million, which were previously delayed from Q1.Kamada Ltd - as detailed by Kamada in its Q1 financial results, revenues from shipment were shifted from Q1 and will be recorded in Q2.  Full Article

Kamada provides update on clinical program for alpha-1 antitrypsin IV treatment
Wednesday, 7 Jun 2017 07:00am EDT 

June 7 (Reuters) - Kamada Ltd :Provides update on clinical program for alpha-1 antitrypsin IV for treatment of graft-versus-host disease.Kamada, Shire agreed INDA approved by U.S. FDA for phase 2/3 study evaluating alpha-1 antitrypsin for treatment of GVHD will be transferred to Kamada.Kamada will take full ownership and responsibility for clinical development of g1-aat iv in this indication.Kamada Ltd says Shire decided to transfer INDA to Kamada due to pipeline prioritization and slow recruitment rate in its current u.s. Study.Kamada will assume control of, and onward funding for full G1-AAT iv program.Kamada Ltd says intends to conduct an integrated clinical development program across both territories - u.s. And eu.Kamada Ltd says as result of this decision, current part 1 of phase 2/3 study conducted in u.s. Is being halted by shire.  Full Article

Shire's angioedema drug succeeds in late-stage study
Thursday, 18 May 2017 07:00am EDT 

May 18 (Reuters) - Shire Plc :Shire's investigational treatment lanadelumab reduces hereditary angioedema monthly attack rate by 87% versus placebo in phase 3 26-week pivotal trial.Says data to serve as basis for U.S. BLA filing expected in Q4 2017 to Q1 2018.Shire - study met its primary endpoint and all secondary endpoints with highly statistically significant, clinically meaningful results for all three lanadelumab treatment arms.Shire Plc - lanadelumab was generally well tolerated over 26-week treatment period.Says no treatment-related serious adverse events or deaths were reported.Shire Plc - plans to submit a biologics license application (BLA) for evaluation by U.S. Food and Drug Administration (FDA) by late 2017 or early 2018.  Full Article

Shire and Parion Sciences enter into a collaborative license agreement
Monday, 1 May 2017 07:00am EDT 

May 1 (Reuters) - Shire Plc ::Shire and Parion Sciences enter into a collaborative license agreement to advance p-321 for ophthalmic indications.Demonstrates ongoing commitment to innovation in ophthalmics for Shire.Shire Plc will make initial $20 million upfront license payment with an additional $20 million payment based on milestone.Parion will be entitled to receive additional potential milestone payments, with a total potential deal value of up to $535 million.Parion has option to co-fund through additional stages of development in exchange for enhanced tiered double-digit royalties..Parion also has option to co-fund commercialization activities and participate in financial outcome from those activities..  Full Article

Shire says ADHD treatment Intuniv receives approval in Japan
Thursday, 30 Mar 2017 04:42am EDT 

Shire Plc :Intuniv (guanfacine hydrochloride prolonged release), a non-stimulant for the treatment of ADHD, receives approval in Japan.  Full Article

BRIEF-Novimmune and Shire sign license agreement deepening bispecific antibody research collaboration​

* ‍NOVIMMUNE AND SHIRE SIGN LICENSE AGREEMENT DEEPENING BISPECIFIC ANTIBODY RESEARCH COLLABORATION​ Source text for Eikon: Further company coverage: (Gdynia Newsroom)