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EMA's CHMP Declines to OK Santhera's Raxone for Blindness
By Nuala Moran Staff Writer LONDON – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has had another Glybera moment, turning down the rare disease drug Raxone (idebenone) by a narrow majority, despite the rapporteurs on an expert committee recommending approval of the drug, which treats a hereditary cause of blindnessBio Perspectives | Wednesday, January 23, 2013 -
EMA's CHMP Declines to OK Santhera's Raxone for Blindness
Shares in Santhera (SWISS:SANN) fell by 20 percent on Friday morning to CHF3.80 when the news was announced.By Nuala Moran | BioWorld International | Wednesday, January 23, 2013 -
New Crescendo Mouse Offers Triple Knockout Technology
Romanos said he is now in talks about a new round to fund the in-house discovery work.By Nuala Moran | BioWorld International | Wednesday, January 23, 2013 -
EMA's CHMP Declines to OK Santhera's Raxone for Blindness
Shares in Santhera (SWISS:SANN) fell by 20 percent on Friday morning to CHF3.80 when the news was announced.By Nuala Moran | BioWorld Today | Tuesday, January 22, 2013 -
Mesoblast's MPC Cell Therapy Neofuse Heading to Phase III
That has come about "because we've been plugging away, not disappearing and getting repeated positive results – the consistency can't be denied."By Nuala Moran | BioWorld International | Wednesday, January 16, 2013 -
Report: Decisions Loom for Value-Based Pricing Effort
That was the first time health care professional bodies and the pharmaceutical industry had agreed to a joint approach on the issue.By Nuala Moran | BioWorld International | Wednesday, January 16, 2013 -
arGEN-X Expands Shire Deal; Starts Phase Ib Cancer Trial
The year ahead is going to be very interesting."By Nuala Moran | BioWorld International | Wednesday, January 9, 2013 -
Heptares' GPCR Platform Lands Cubist Collaboration
Heptares said its stabilized GPCRs preserve all biologically relevant epitopes and allow a diverse panel of functional antibodies to be obtained when they are used as an antigen for in vivo immunization.By Nuala Moran | BioWorld International | Wednesday, January 9, 2013 -
Heptares' GPCR Platform Lands Cubist Collaboration
Heptares said its stabilized GPCRs preserve all biologically relevant epitopes and allow a diverse panel of functional antibodies to be obtained when they are used as an antigen for in vivo immunization.By Nuala Moran | BioWorld Today | Tuesday, January 8, 2013 -
GlycoVaxyn Finalizes Deal to Fund Bioconjugation Program
We are fairly well positioned to bring solutions to these problems," Dro said.By Nuala Moran | BioWorld International | Wednesday, January 2, 2013 -
Four Decades of Work Yields Single European Patent System
The European system is an expensive nightmare so it will be an advance, especially avoiding the need for translation," he told BioWorld International.By Nuala Moran | BioWorld International | Wednesday, January 2, 2013 -
Four Decades of Work Yields Single European Patent System
The European system is an expensive nightmare so it will be an advance, especially avoiding the need for translation," he told BioWorld Today.By Nuala Moran | BioWorld Today | Wednesday, January 2, 2013 -
Poxel Adds $17M in Series B for Diabetes Drug Imeglimin
A Phase III for diabetes is huge."By Nuala Moran | BioWorld International | Wednesday, December 26, 2012 -
GSK Spinout NeRRe Begins with $19M, Neurokinin Drugs
Last month Aptuit said it had reached an agreement on a multiyear extension of the partnership with GSK.By Nuala Moran | BioWorld International | Wednesday, December 26, 2012 -
Vaccines Firm Goes to Vivalis in All-Share Deal Worth $175M
The rights issue already is guaranteed, with the French public fund Fonds Stratégique d'Investissement agreeing to subscribe up to €25 million, while Groupe Grimaud and Unigrains (one of Groupe Grimaud's long-term shareholders) have said they will take up €5 million, and two banks have committed to underwrite €10 million under standard terms.By Nuala Moran | BioWorld International | Wednesday, December 19, 2012 -
Evotec Finds New Partner for NMDA Drugs in Janssen Deal
Upon achievement of certain preclinical, clinical, regulatory and commercial goals, Janssen would make future milestone payments of up to $300 million per product.By Nuala Moran | BioWorld International | Wednesday, December 19, 2012 -
Evotec Finds New Partner for NMDA Drugs in Janssen Deal
Upon achievement of certain preclinical, clinical, regulatory and commercial goals, Janssen would make future milestone payments of up to $300 million per product.By Nuala Moran | BioWorld Today | Tuesday, December 18, 2012 -
Vaccines Firm Goes to Vivalis in All-Share Deal Worth $175M
The rights issue already is guaranteed, with the French public fund Fonds Stratégique d'Investissement agreeing to subscribe up to €25 million, while Groupe Grimaud and Unigrains (one of Groupe Grimaud's long-term shareholders) have said they will take up €5 million, and two banks have committed to underwrite €10 million under standard terms.By Nuala Moran | BioWorld Today | Tuesday, December 18, 2012 -
Evotec Finds New Partner for NMDA Drugs in Janssen Deal
Upon achievement of certain preclinical, clinical, regulatory and commercial goals, Janssen would make future milestone payments of up to $300 million per product.By Nuala Moran | BioWorld Today | Monday, December 17, 2012 -
Study Confirms Zytiga's Benefit in Earlier-Stage Prostate Cancer
But given median overall survival was not reached in 22.2 months of follow-up in the Phase III trial, and with no limiting toxic side effects seen to date, patients could be taking Zytiga for two years or longer.By Nuala Moran | BioWorld Today | Friday, December 14, 2012
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