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Shire PLC (SHP.L)

SHP.L on London Stock Exchange

4,366.00GBp
24 Jan 2017
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Latest Key Developments (Source: Significant Developments)

U.S FDA acknowledges receipt of Shire's ADHD drug application
Thursday, 19 Jan 2017 07:04am EST 

Shire Plc : U.S. FDA acknowledges receipt of Shire's new drug application for SHP465 for ADHD . fda has acknowledged receipt of class 2 resubmission of a new drug application (nda) for shp465, a long-acting, triple-bead, mixed amphetamine salts formulation . Shp465 is being evaluated as a potential once-daily treatment for attention-deficit/hyperactivity disorder . FDA is expected to provide a decision on or around june 20, 2017, designated prescription drug user fee act (PDUFA) action date .Protection for shire's ADHD franchise extends to 2029.  Full Article

Momenta provides year-end 2016 corporate update
Friday, 6 Jan 2017 08:00am EST 

Momenta Pharmaceuticals Inc : Momenta provides year-end 2016 corporate update . Momenta Pharmaceuticals Inc - reiterated its non-gaap operating expense guidance of approximately $40 - $45 million for Q4 of 2016 . Momenta Pharmaceuticals Inc - expects to report approximately $350.0 million of cash, cash equivalents and marketable securities at December 31, 2016 .Momenta Pharmaceuticals Inc - currently assessing U.S. Gaap accounting treatment for shire and csl agreements.  Full Article

RaNa acquires Shire's industry leading messenger RNA platform
Wednesday, 4 Jan 2017 07:30am EST 

Shire Plc : RaNa acquires Shire's industry leading messenger RNA platform . RaNa Therapeutics announces acquisition of MRT platform, an MRNA therapy platform, developed by subsidiaries of Shire .RaNa Therapeutics says Shire to receive equity stake in RaNa and is eligible for future milestones and royalties on products developed with technology.  Full Article

Shire says topline results of Phase 3 investigational study of Vonvendi meets primary endpoint
Friday, 2 Dec 2016 11:02am EST 

Shire Plc : Topline results of Phase 3 investigational study of Vonvendi™ [von Willebrand factor (recombinant)] meets primary endpoint effectively controlling bleeding and blood loss during surgical procedures . Vonvendi is also being studied for prophylaxis and pediatric indications . Results of Phase 3 investigational study of Vonvendi Willebrand factor meets primary endpoint .Results from Phase 3 investigational study to be used to support filing for regulatory approvals in Europe in 2017 and in other markets globally.  Full Article

AMRI announces API agreement supply with Shire
Tuesday, 29 Nov 2016 07:45am EST 

Albany Molecular Research Inc - : AMRI announces API agreement supply with Shire . Terms of agreement are confidential .Has entered into a multi-year supply agreement for an undisclosed product with shire us manufacturing.  Full Article

Mmenta Pharmaceuticals to regain global development and commercialization rights to M923
Tuesday, 27 Sep 2016 08:00am EDT 

Momenta Pharmaceuticals Inc. : Momenta Pharmaceuticals to regain global development and commercialization rights to M923, a proposed biosimilar of HUMIRA (adalimumab), through termination of collaboration agreement with Baxalta, now part of Shire . Agreement to terminate 12 months following notice; Shire will continue to be obligated to fund M923 program till termination . Momenta Pharmaceuticals to regain global development and commercialization rights to M923, a proposed biosimilar of HUMIRA (adalimumab), through termination of collaboration agreement with Baxalta, now part of Shire .Co expects top-line results of current phase 3 trial of M923 in late 2016.  Full Article

Coherus Biosciences regains development and commercial rights to CHS-0214 from Shire
Tuesday, 27 Sep 2016 08:00am EDT 

Coherus Biosciences Inc. : Says has regained from shire plc all development and commercial rights previously licensed for chs-0214 etanercept . Coherus Biosciences regains development and commercial rights to CHS 0214 from Shire . As result of termination agreement with Shire, co expects to recognize $162.6 million as collaboration and license revenues in 2016 . CHS-0214 etanercept is a biosimilar candidate to enbrel for Europe, Canada, Brazil, Middle East and other territories .Remain on track for submission of a CHS-0214 marketing authorization application to european medicines agency in Q4 of 2016.  Full Article

Shire says prescription eye drop, xiidra 5% is now available in U.S.
Monday, 29 Aug 2016 10:47am EDT 

Shire Plc :Prescription eye drop, xiidra 5% is now available in the u.s..  Full Article

Shire launches Von Willebrand disease drug in the U.S
Tuesday, 9 Aug 2016 07:14am EDT 

Shire Plc :Announced U.S. launch of Vonvendi [von willebrand factor (recombinant)], only recombinant treatment for adults living with Von Willebrand Disease.  Full Article

Shire CEO says can 'hopefully do better' on Baxalta M&A target
Tuesday, 2 Aug 2016 07:00am EDT 

Shire Plc : Ceo says shire will not be engaged in larger scale m&a . Ceo says can 'hopefully do even better' than new $700 million cost savings target fin baxalta deal Further company coverage: [SHP.L] (Reporting By London Bureau) ((uk.online@reuters.com; +44 20 7542 7717;)).  Full Article

BRIEF-U.S FDA acknowledges receipt of Shire's ADHD drug application

* U.S. FDA acknowledges receipt of Shire's new drug application for SHP465 for ADHD