Early access and regulation

Another lost decade for research?
Another lost decade for research? What does the patent landscape look like for antibiotics, vaccines and orphan drugs?
First von Willebrand disease therapy heads new FDA approvals
First von Willebrand disease therapy heads new FDA approvals Baxalta's Vonvendi set for an early 2016 launch in the US
Wakix backed for European approval in narcolepsy
Wakix backed for European approval in narcolepsy Bioprojet Pharma’s orphan drug given a positive opinion by CHMP
FDA grants Tocagen’s glioblastoma drug orphan status
FDA grants Tocagen’s glioblastoma drug orphan status Puts the brain cancer gene therapy in-line for development incentives
Sobi wins European approval for oral form of orphan drug Orfadin
Sobi wins European approval for oral form of orphan drug Orfadin Expandstreatment options for rare genetic disease HT-1
Sanofi gains accelerated review for rare disease drug
Sanofi gains accelerated review for rare disease drug New pill for Fabry disease could be approved by the FDA before the end of the year
AstraZeneca gains FDA orphan status for new cancer drug
AstraZeneca gains FDA orphan status for new cancer drug Gains a longer patent life for the investigational lung disease drug
Eisai’s thyroid cancer drug Lenvima nears EU approval
Eisai’s thyroid cancer drug Lenvima nears EU approval Positive recommendation by the CHMP could see the orphan drug used in Europe within three months
FDA grants orphan drug status to Treeway's ALS treatment
FDA grants orphan drug status to Treeway's ALS treatment Amyotrophic Lateral Sclerosis drug TW001 gainsregulatory benefits
FDA clears first therapy for rare childhood cancer
FDA clears first therapy for rare childhood cancer United Therapeutics’ Unituxin approved for neuroblastoma
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