BioCentury | Apr 6, 2018
Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
BC Week In Review | Feb 16, 2018
Clinical News

EC approves Diurnal's Alkindi

Diurnal Group plc (LSE:DNL) said the European Commission approved Alkindi (Infacort) as a replacement therapy to treat adrenal insufficiency in individuals less than 18 years old. Diurnal plans to launch Alkindi in 2Q18, but told...
BC Extra | Feb 13, 2018
Company News

EC approves Diurnal's Alkindi

Diurnal Group plc (LSE:DNL) said the European Commission approved Alkindi (Infacort) as a replacement therapy to treat adrenal insufficiency in individuals less than 18 years old. Diurnal plans to launch Alkindi in 2Q18, but told...
BC Week In Review | Dec 22, 2017
Clinical News

CHMP recommends Diurnal's Alkindi for pediatric adrenal insufficiency

EMA's CHMP recommended approval of Alkindi (Infacort) from Diurnal Ltd. (Cardiff, U.K.) as replacement therapy for pediatric adrenal insufficiency. The company expects a final decision in February and anticipates a launch in 2Q18. The product...
BC Week In Review | Apr 20, 2017
Company News

Diurnal, Clinigen sales and marketing update

Clinigen launched a patient access program in Europe to provide Diurnal’s cortisol deficiency candidates Infacort and Chronocort on a named-patient basis to patients who have no other treatment options. Infacort is under EMA review to...
BC Week In Review | Oct 31, 2016
Clinical News

Infacort: Extension study started

Diurnal began an open-label extension study in up to 24 patients ages <6 who completed treatment in a German Phase III trial of 0.5, 1, 2 and 5 mg oral Infacort. The trial, which met...
BC Week In Review | Oct 24, 2016
Clinical News

Infacort: Phase III final data

Final data from an open-label, German Phase III trial in 24 patients ages <6 with adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism showed that a single dose of oral Infacort...
BC Week In Review | Oct 24, 2016
Clinical News

Chronocort: Phase III started

Diurnal began an open-label, European Phase III trial to compare 5, 10 and 20 mg oral Chronocort vs. glucocorticoid replacement therapy in 110 patients. Diurnal Ltd. , Cardiff, U.K.  Product: Chronocort   Business: Endocrine/Metabolic  Molecular target:...
BC Week In Review | Aug 1, 2016
Clinical News

Infacort: Phase III data

Top-line data from an open-label, German Phase III trial in 24 patients ages <6 with adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism showed that a single dose of oral Infacort...
BC Week In Review | Jul 18, 2016
Company News

Citius Pharmaceuticals sales and marketing update

Citius said it will discontinue FDA-approved Suprenza phentermine orally disintegrating tablets to treat obesity. The company noted the obesity and weight management market has “shifted” and the sympathomimetic amine anorectic “no longer meets our core...
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