BioCentury | Feb 4, 2020
Product Development

Insmed planning Phase III for rare lung disorder therapy following mixed Phase II readout

...transformation into a rare pulmonary disease company, the company had sold its manufacturing facility for iPlex...
BioCentury | May 11, 2018
Strategy

Takeda hits the gas

...Takeda The specialty pharma also has two first-in-class candidates in Phase II, including IPlex mecasermin rinfabate (SHP607...
...mecasermin rinfabate (SHP607) for chronic lung disease, and SHP611 in Phase I/II testing to treat leukodystrophy. IPlex...
BioCentury | Jul 11, 2016
Clinical News

Mecasermin rinfabate: Phase II data

...gestational age of 23 weeks-27 weeks and 6 days showed that once-daily 250 ug/kg IV SHP607...
...care. In patients who achieved a pre-specified target SHP607 exposure based on serum IGF-1 concentration, SHP607...
...LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Mecasermin rinfabate ( Premiplex , iPlex ) ( SHP607 ) (formerly HGT-ROP-001...
BioCentury | Jul 11, 2016
Finance

Shedding red

...quarter, FDA requests additional data from a Phase III confirmatory trial Shire plc (LSE:SHP; NASDAQ:SHPG) SHP607...
BioCentury | Jul 1, 2016
Clinical News

Shire's SHP607 misses retinopathy endpoint

...Shire plc (LSE:SHP; NASDAQ:SHPG) said SHP607 missed the primary endpoint in a Phase II study. The...
...occurs in premature babies. The study enrolled 121 extremely premature infants who received continuous IV SHP607...
...30 weeks, when a fetus typically begins endogenously producing insulin-like growth factor-1 ( IGF-1 ). SHP607...
BioCentury | Dec 11, 2014
Company News

Shire, CF Foundation in $15M discovery deal

...to contribute $3 billion in sales by 2020. Shire also said its Premiplex mecasermin rinfabate ( SHP607...
BioCentury | Jul 21, 2014
Strategy

AbbVie's plan B

...an NDA in 1Q15 without having to conduct additional studies. Its other ophthalmic candidate is SHP607...
...sales of $500 million in the same time frame. Shire attached another $500 million to SHP607...
BioCentury | Nov 18, 2013
Strategy

Shire goes vertical

...Shire has four rare disease programs in the clinic. Two are in Phase II, including SHP607...
...acquisition of FerroKin BioSciences Inc. , has Orphan Drug designation in the U.S. and EU. SHP607...
...to current therapies Ph II rights outside of Japan from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) Mecasermin rinfabate (SHP607...
BioCentury | May 20, 2013
Strategy

Let a thousand ideas bloom

...rare diseases with unmet needs," Vickers told BioCentury. With the Premacure deal, Shire gained the Premiplex...
...three-year deal; Nimbus is eligible for undisclosed milestones May-13 Premacure AB Company acquisition Gains Premacure's Premiplex...
BioCentury | Apr 1, 2013
Strategy

Shire sees opportunity

...12 when Shire announced the acquisition of Premacure AB . The Swedish company's Premiplex (formerly iPlex...
...to be the early loss of hormones like IGF-1 that are delivered in utero . Premiplex...
...was developed to increase levels of IGF-1 in premature infants to normal gestational levels. Early Premiplex...
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