BC Week In Review | Apr 28, 2017
Company News

Avadel restructuring news

In March, Avadel said it would reduce headcount by about 50 in France, where it conducts all of its R&D operations. After the cuts, the company would have about 50 employees remaining in France. Avadel...
BC Week In Review | Dec 20, 2016
Clinical News

FT218: Ph III REST-ON started

Flamel began the double-blind, placebo-controlled, international Phase III REST-ON trial to evaluate once-nightly 4.5-9 mg oral FT218 in 264 patients. Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France  Product: Sodium oxybate delivered via Micropump technology (FT218)  Business:...
BC Week In Review | Jan 11, 2016
Clinical News

Medusa Exenatide XL: Interim Phase Ia data

Flamel said interim data from a 2-part Phase Ia trial in healthy volunteers showed that single ascending doses of FT228 met all safety and pharmacokinetic endpoints. In part 1, 40 subjects received FT228 or twice-daily...
BC Week In Review | Sep 21, 2015
Clinical News

Not disclosed regulatory update

Flamel said FDA accepted for review an NDA for an undisclosed product. The PDUFA date is April 30, 2016. Flamel declined to disclose details on the product or indication. Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France...
BC Extra | Jun 27, 2015
Company News

Management tracks

CNS company KemPharm Inc. (NASDAQ:KMPH) promoted LaDuane Clifton to CFO from VP of finance and corporate controller. He replaces Gordon Johnson, who became CBO. Food allergy company DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) named Hugh Sampson...
BC Week In Review | Dec 8, 2014
Financial News

Flamel completes private placement

Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France   Business: Drug delivery   Date completed: 2014-12-02   Type: Private placement   Raised: $13 million   Shares: 1 million   Price: $12.71 (ADS)   Shares after offering: 40...
BC Week In Review | Jul 28, 2014
Clinical News

Vazculep phenylephrine regulatory update

FDA approved an NDA from Flamel for Vazculep phenylephrine to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel plans to launch the adrenergic receptor alpha 1 ( ADRA1 ) agonist in...
BC Week In Review | May 12, 2014
Clinical News

Sodium oxybate delivered via Micropump technology: Clinical trial data

Flamel reported data from a crossover trial in 14 evaluable healthy volunteers showing that sodium oxybate delivered with Flamel's Micropump drug delivery technology at a nightly dose of 4.5 g could eliminate the need for...
BC Week In Review | May 5, 2014
Clinical News

Not disclosed regulatory update

Flamel received a complete response letter from FDA for an NDA for an undisclosed product. The biotech said the agency cited deficiencies found at an inspection of the API supplier of the product. Flamel, which...
BioCentury | Apr 14, 2014
Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 4/11 cls Agios Pharmaceuticals Inc. (NASDAQ:AGIO) JPMorgan Geoffrey Meacham Upgrade Overweight (from neutral) 22% $43.32 Meacham also raised his target to $55 from $40...
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1 - 10 of 203
BC Week In Review | Apr 28, 2017
Company News

Avadel restructuring news

In March, Avadel said it would reduce headcount by about 50 in France, where it conducts all of its R&D operations. After the cuts, the company would have about 50 employees remaining in France. Avadel...
BC Week In Review | Dec 20, 2016
Clinical News

FT218: Ph III REST-ON started

Flamel began the double-blind, placebo-controlled, international Phase III REST-ON trial to evaluate once-nightly 4.5-9 mg oral FT218 in 264 patients. Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France  Product: Sodium oxybate delivered via Micropump technology (FT218)  Business:...
BC Week In Review | Jan 11, 2016
Clinical News

Medusa Exenatide XL: Interim Phase Ia data

Flamel said interim data from a 2-part Phase Ia trial in healthy volunteers showed that single ascending doses of FT228 met all safety and pharmacokinetic endpoints. In part 1, 40 subjects received FT228 or twice-daily...
BC Week In Review | Sep 21, 2015
Clinical News

Not disclosed regulatory update

Flamel said FDA accepted for review an NDA for an undisclosed product. The PDUFA date is April 30, 2016. Flamel declined to disclose details on the product or indication. Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France...
BC Extra | Jun 27, 2015
Company News

Management tracks

CNS company KemPharm Inc. (NASDAQ:KMPH) promoted LaDuane Clifton to CFO from VP of finance and corporate controller. He replaces Gordon Johnson, who became CBO. Food allergy company DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) named Hugh Sampson...
BC Week In Review | Dec 8, 2014
Financial News

Flamel completes private placement

Flamel Technologies S.A. (NASDAQ:FLML), Lyon, France   Business: Drug delivery   Date completed: 2014-12-02   Type: Private placement   Raised: $13 million   Shares: 1 million   Price: $12.71 (ADS)   Shares after offering: 40...
BC Week In Review | Jul 28, 2014
Clinical News

Vazculep phenylephrine regulatory update

FDA approved an NDA from Flamel for Vazculep phenylephrine to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel plans to launch the adrenergic receptor alpha 1 ( ADRA1 ) agonist in...
BC Week In Review | May 12, 2014
Clinical News

Sodium oxybate delivered via Micropump technology: Clinical trial data

Flamel reported data from a crossover trial in 14 evaluable healthy volunteers showing that sodium oxybate delivered with Flamel's Micropump drug delivery technology at a nightly dose of 4.5 g could eliminate the need for...
BC Week In Review | May 5, 2014
Clinical News

Not disclosed regulatory update

Flamel received a complete response letter from FDA for an NDA for an undisclosed product. The biotech said the agency cited deficiencies found at an inspection of the API supplier of the product. Flamel, which...
BioCentury | Apr 14, 2014
Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 4/11 cls Agios Pharmaceuticals Inc. (NASDAQ:AGIO) JPMorgan Geoffrey Meacham Upgrade Overweight (from neutral) 22% $43.32 Meacham also raised his target to $55 from $40...
Items per page:
1 - 10 of 203