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Sanofi lawsuit tries to hold Merck Lantus biosimilar at bayJust because Sanofi negotiated a settlement that allows Eli Lilly to launch its Lantus biosimilar injectorin mid-December does not mean the French drugmaker is prepared to cede U.S. market share to an2016/10/25
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Mylan CEO faces grilling on Capitol Hill as senators unveil price-hike legislationThe EpiPen drama is moving into a congressional hearing room. Mylan CEO Heather Bresch is on the docket to testify next Wednesday for the House Committee on Oversight and Government Reform, where she’2016/10/24
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Teva's trying to weasel out of its Mexican generics deal, new Rimsa lawsuit saysTurns out Teva didn’t quite know what it was getting itself into when it agreed to buy out Mexico’s Rimsa last year for $2.3 billion. The Israeli generics giant is suffering “buyer’s remorse” and loo2016/10/24
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Milo Biotechnology receives orphan drug designation for AAV1-FS344 to treat inclusion body myositisMilo Biotechnology has secured Orphan Drug designation for its AAV1-FS344 from the Federal Drug Administration’s (FDA) Office of Orphan Products Development for treatment of inclusion body myositis.2016/10/21
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US FDA grants breakthrough therapy designation to AbbVie's G/P to treat HCVAbbVie's investigational, pan-genotypic regimen of glecaprevir (ABT-493) / pibrentasvir (ABT-530) (G/P) has received breakthrough therapy designation from the US Food and Drug Administration (FDA) to2016/10/21
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US FDA grants approval for Novartis' Ilaris to treat Periodic Fever SyndromesNovartis has received the US Food and Drug Administration's (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. Periodic Fever Syndromes are a group of diseases2016/10/20
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US FDA accepts Sanofi and Regeneron’s dupilumab BLA for priority reviewThe US Food and Drug Administration (FDA) has granted priority review status to Sanofi and Regeneron’s biologics license application (BLA) for dupilumab to treat adult patients with inadequately contr2016/10/20
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EC grants marketing authorisation for Aptalis’s Truberzi to treat IBS-DThe European Commission (EC) has granted marketing authorisation for Aptalis’s Truberzi (eluxadoline) in Europe. Rights to the drug will shortly be transferred back to Allergan, following thesale of2016/10/19
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US FDA approves Janssen's Invokamet XR for type 2 diabetes treatment in adultsThe US Food and Drug Administration (FDA) has granted approval for Janssen Pharmaceuticals' Invokamet XR to treat type 2 diabetes in adults. Invokamet XR is a once-daily, fixed-dose combination thera2016/10/19
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EMA confirms safety of plasma and urine-derived medicines from Zika virus contaminationThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed that plasma or urine-derived medicines are safe for use in Europe. The agency confirmed that2016/10/18