BioCentury | Jan 5, 2019
Finance

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Oct 26, 2018
Clinical News

ViiV seeks FDA approval for two-drug HIV-1 regimen

...voucher that GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received this year when FDA approved malaria drug Krintafel tafenoquine...
BioCentury | Oct 6, 2018
Finance

Large cap comeback

...two or more lines of systemic therapy GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) FDA approves single-dose Krintafel tafenoquine...
BioCentury | Jul 27, 2018
Clinical News

FDA committee: 60 Degrees' malaria candidate safe and effective

...FDA's Antimicrobial Drugs Advisory Committee voted that malaria candidate Arakoda tafenoquine (60P003) from 60 Degrees Pharmaceuticals...
...60 Degrees Pharmaceuticals LLC (Washington, D.C.) is effective and safe. The panel voted 11-2 that tafenoquine...
...the product was safe. The 8-aminoquinoline is under Priority Review. This month, FDA approved Krintafel tafenoquine...
BioCentury | Jul 27, 2018
Clinical News

FDA approves GSK's Krintafel to prevent malaria relapse

...GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Medicines for Malaria Venture (MMV) said FDA approved single-dose Krintafel tafenoquine...
...plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Krintafel tafenoquine Business: Infectious Jaime De Leon Krintafel, tafenoquine (TQ, SB 252263, WR-238605) GlaxoSmithKline...
BioCentury | Jul 26, 2018
Company News

FDA committee: 60 Degrees' malaria candidate safe and effective

...FDA's Antimicrobial Drugs Advisory Committee voted that malaria candidate tafenoquine (60P003) from 60 Degrees Pharmaceuticals LLC...
...60 Degrees Pharmaceuticals LLC (Washington, D.C.) is effective and safe. The panel voted 11-2 that tafenoquine...
...the product was safe. The 8-aminoquinoline is under Priority Review. Last week, FDA approved Krintafel tafenoquine...
BioCentury | Jul 20, 2018
Company News

FDA approves Krintafel to prevent malaria relapse

...GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Medicines for Malaria Venture (MMV) said FDA approved single-dose Krintafel tafenoquine...
...breakthrough therapy designation. The product is also under review in Australia. Jaime De Leon TQ, tafenoquine (SB 252263, WR-238605) GlaxoSmithKline...
BioCentury | Jul 13, 2018
Clinical News

FDA panel votes in favor of GSK's malaria candidate

...tafenoquine would be the first new medicine for this indication in more than 60 years. Tafenoquine...
...from FDA. The proposed U.S. proprietary name for tafenoquine is Krintafel. GSK, which is developing tafenoquine...
...Australia. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Tafenoquine Business: Infectious Elizabeth S. Eaton TQ, tafenoquine (SB 252263, WR-238605) GlaxoSmithKline...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

...patients with COPD guided by blood eosinophil counts FDA panel 7/25/18 GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) Tafenoquine...
BioCentury | Jun 29, 2018
Clinical News

FDA panel to discuss GSK’s malaria candidate

...malaria. Tafenoquine, an 8-aminoquinoline derivative, has breakthrough therapy designation from FDA. GSK, which is developing tafenoquine...
...in Australia. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Tafenoquine Business: Infectious Meghan Sullivan TQ, tafenoquine (SB 252263, WR-238605) GlaxoSmithKline...
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