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First all-oral treatment for sleeping sickness leads positive recommendations from CHMP's November meeting firstwordpharma
November 19, 2018
At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended four drugs for approval
FDA panel slams Alkermes’ opioid-based depression drug fiercebiotech
November 05, 2018
It has been a long and difficult road for Alkermes’ new depression drug, and Thursday’s advisory committee vote won’t make it any easier. The panel voted 21-2 against recommending...
FDA staff spotlight big—but expected—issues on Alkermes' depression drug fiercebiotech
November 02, 2018
The FDA raised significant—but expected—concerns about Alkermes’ major depressive disorder drug ALKS-5461 in briefing documents released (PDF) ahead of an advisory committee
FDA sets back review date of Acorda’s levodopa inhaler for Parkinson’s disease fiercebiotech
September 18, 2018
The agency set a new review deadline for Acorda’s levodopa inhaler, for Jan. 5, 2019, after requesting more info on its chemistry, manufacturing and controls.
FDA clears Baxter’s prepackaged synthetic bone filler graft fiercebiotech
September 10, 2018
Baxter expects the bone filler to be used in surgeries in the pelvis, extremities and spine, to help repair small bone defects and complex geometries.
Illumina receives 1st approval in China for its MiSeqDx sequencing system fiercebiotech
August 30, 2018
With a certificate from the China National Drug Administration, Illumina has begun encouraging more clinical laboratories to choose the MiSeqDx system to develop new clinical assays.
FDA approves Roche’s cobas EGFR blood test as a companion diagnostic for AZ’s Iressa fiercebiotech
August 28, 2018
The FDA's OK follows companion diagnostic approvals in NSCLC for tyrosine kinase inhibitors Tarceva and Tagrisso. (Roche)
Samsung BioLogics’ stock slides after regulators claim accounting rules infraction fiercepharma
May 03, 2018
Contract drug manufacturing giant Samsung BioLogics saw its stock slide, losing almost $6 billion in market value Wednesday, after South Korean securities ...
European Commission grants orphan drug designation to NeuroVive KL pharmaasia
December 22, 2017
The NeuroVive KL1333 programme targets oral treatment of Mitochondrial Myopathy, Encephalopathy, Lactic acidosis and Stroke-like episodes (MELA

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