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US clears first drug for tardive dyskinesia
pharmatimes
April 14, 2017
Neurocrine Biosciences’ Ingrezza has become the first drug approved to treat the hyperkinetic movement disorder tardive dyskinesia in the US.
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SMC approves anti-HIV drug PrEP
pharmaceutical-technology
April 14, 2017
The Scottish Medicines Consortium (SMC) has approved the treatment known as Pre Exposure Prophylaxis (PrEP) that reduces the chances of being infected with HIV.
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EMA green lights Actelion’s drug after patient deaths scare
pharmafile
April 11, 2017
The EMA has ruled that the five patient deaths that occurred in February of this year were not directly related to ...
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Novartis takes on dry-eye market with drug in-licensing move
April 10, 2017
Novartis has announced that its eyecare-focused division Alcon has in-licensed dry-eye drug ECF843 from US firm Lubris...
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US beats EU on drug review times, approvals
pharmatimes
April 10, 2017
US regulators have outpaced their European counterparts both on the number of new medicines approved and length of review times between 2011 and 2015, shows a new analysis published by the New England Journal of Medicine.
According to the data, the US
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Novartis takes home rights to Lubris’ eye drug
pharmatimes
April 10, 2017
Novartis has elected to exercise an option to in-license experimental eye drug ECF843 from US biopharma Lubris.
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CN Bio licences Hepatitis B drug discovery programme from Bristol-Myers Squibb
pharmaceutical-technology
April 10, 2017
UK’s CN Bio Innovations has licenced a Hepatitis B drug discovery programme from Bristol-Myers Squibb Company.
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RedHill Biopharma’s Yeliva obtains orphan drug designation from US FDA
pharmaceutical-technology
April 10, 2017
RedHill Biopharma’s Yeliva (ABC294640) has secured orphan drug designation from the US Food and Drug Administration...
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Orphan status for GW’s rare epilepsy drug
pharmatimes
March 31, 2017
London, UK-based GW Pharmaceuticals’ cannabinoid Epidiolex has been awarded Orphan status by European regulators as a treatment for Lennox-Gastaut Syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
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AZ’ neuromyelitis drug picks up Orphan status in EU
pharmatimes
March 30, 2017
European regulators have awarded AstraZeneca’s inebilizumab (formerly MEDI-551) Orphan status for the treatment of neuromyelitis optica spectrum disorder (NMOSD), opening the ...