BioCentury | Aug 21, 2014
Tools & Techniques

Circling back to basics

...Mass. e-mail: whitty@bu.edu Contact : Sandor Vajda, same affiliation as above e-mail: vajda@bu.edu Contact : Dima...
BioCentury | Aug 21, 2014
Distillery Techniques

Technology: Chemistry

...University, Boston, Mass. e-mail: whitty@bu.edu Contact: Sandor Vajda, same affiliation as above e-mail: vajda@bu.edu Contact: Dima...
BioCentury | Aug 15, 2011
Company News

Gilead, Astellas infectious news

Gilead said FDA accepted the company's response to a warning letter issued last year over violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead said the issues...
BioCentury | Oct 4, 2010
Clinical News

Macugen pegaptanib regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

Cayston aztreonam lysine regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

AmBisome amphotericin B regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

Viread tenofovir disoproxil fumarate regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Aug 16, 2010
Finance

Regulatory milestones

Labopharm Inc. (TSX:DDS; NASDAQ:DDSS) fell C$0.17 (14%) to C$1.05 in Toronto on Thursday after Health Canada delayed a decision on an NDS for once-daily trazodone to treat major depressive disorder (MDD) due to a backlog...
BioCentury | Aug 16, 2010
Clinical News

AmBisome liposomal amphotericin B regulatory update

Gilead disclosed in an SEC filing that FDA "may be considering" issuing a warning letter about concerns observed during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead believes it has addressed all...
BioCentury | Aug 10, 2010
Company News

FDA raises concerns at Gilead facility

Gilead Sciences Inc. (NASDAQ:GILD) disclosed in an SEC filing that FDA "may be considering" issuing a warning letter about concerns observed during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead believes it...
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1 - 10 of 20
BioCentury | Aug 21, 2014
Tools & Techniques

Circling back to basics

...Mass. e-mail: whitty@bu.edu Contact : Sandor Vajda, same affiliation as above e-mail: vajda@bu.edu Contact : Dima...
BioCentury | Aug 21, 2014
Distillery Techniques

Technology: Chemistry

...University, Boston, Mass. e-mail: whitty@bu.edu Contact: Sandor Vajda, same affiliation as above e-mail: vajda@bu.edu Contact: Dima...
BioCentury | Aug 15, 2011
Company News

Gilead, Astellas infectious news

Gilead said FDA accepted the company's response to a warning letter issued last year over violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead said the issues...
BioCentury | Oct 4, 2010
Clinical News

Macugen pegaptanib regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

Cayston aztreonam lysine regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

AmBisome amphotericin B regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Oct 4, 2010
Clinical News

Viread tenofovir disoproxil fumarate regulatory update

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing...
BioCentury | Aug 16, 2010
Finance

Regulatory milestones

Labopharm Inc. (TSX:DDS; NASDAQ:DDSS) fell C$0.17 (14%) to C$1.05 in Toronto on Thursday after Health Canada delayed a decision on an NDS for once-daily trazodone to treat major depressive disorder (MDD) due to a backlog...
BioCentury | Aug 16, 2010
Clinical News

AmBisome liposomal amphotericin B regulatory update

Gilead disclosed in an SEC filing that FDA "may be considering" issuing a warning letter about concerns observed during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead believes it has addressed all...
BioCentury | Aug 10, 2010
Company News

FDA raises concerns at Gilead facility

Gilead Sciences Inc. (NASDAQ:GILD) disclosed in an SEC filing that FDA "may be considering" issuing a warning letter about concerns observed during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead believes it...
Items per page:
1 - 10 of 20