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 8, 2018
Company News

Management tracks: As Akcea shifts to commercialization, Crooke resigns from board

...Ansun BioPharma Inc. (San Diego, Calif.) hired Stanley Lewis as CMO. He was CMO of TaiMed Biologics Inc....
BioCentury | Apr 6, 2018
Finance

Fundamentally driven

...moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy Theratechnologies Inc. (TSX:TH) / TaiMed Biologics Inc....
BioCentury | Mar 9, 2018
Clinical News

FDA approves mAb for multidrug-resistant HIV

...therapies. Theratechnologies Inc. (TSX:TH), which has U.S. rights to market and distribute the drug from TaiMed Biologics Inc....
...a month ahead of Trogarzo's PDUFA date, which FDA had extended to review manufacturing information TaiMed...
...first biologic manufactured in China to receive FDA clearance for U.S. use under an IND. TaiMed's...
BioCentury | Mar 7, 2018
Company News

WuXi Biologics, TaiMed rise after FDA approves mAb for HIV

...in China that FDA has approved (see BioCentury Extra, March 6) . WuXi Biologics' partner TaiMed Biologics Inc....
...TSX:TH), which has U.S. rights to market and distribute the drug under a deal with TaiMed...
...Priority Review, and has Fast Track, breakthrough therapy and Orphan Drug status to treat HIV. Paul Bonanos ibalizumab TaiMed Biologics Inc. Theratechnologies...
BioCentury | Mar 6, 2018
Company News

FDA approves mAb for multidrug-resistant HIV

...therapies. Theratechnologies Inc. (TSX:TH), which has U.S. rights to market and distribute the drug from TaiMed Biologics Inc....
...a month ahead of Trogarzo's PDUFA date, which FDA had extended to review manufacturing information TaiMed...
...first biologic manufactured in China to receive FDA clearance for U.S. use under an IND. TaiMed's...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...Aviv:TEVA) / Pfizer Inc. (NYSE:PFE) Fremanezumab Prevent migraine PDUFA date Mid-2018 Theratechnologies Inc. (TSX:TH) / TaiMed Biologics Inc....
BioCentury | Nov 30, 2017
Clinical News

FDA extends PDUFA for Theratechnologies' ibalizumab to treat HIV

...Theratechnologies Inc. (TSX:TH) and TaiMed Biologics Inc. (TPEx:4147) said FDA extended by 3 months the PDUFA date for...
...Theratechnologies said FDA extended the date to allow time to review manufacturing information submitted by TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
BioCentury | Aug 16, 2017
Clinical News

TaiMed's ibalizumab gets FDA Priority Review for HIV

...for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. Its PDUFA date is Jan. 3, 2018. TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
...Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHBBY) (see BioCentury, Sept. 24, 2007 ). In 2016, TaiMed...
BioCentury | May 12, 2017
Clinical News

TaiMed submits BLA to FDA for HIV candidate ibalizumab

...Inc. (TPEx:4147) submitted a BLA to FDA for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. TaiMed...
...prevents viral entry. It has breakthrough therapy and Orphan Drug designations to treat HIV, and TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
Items per page:
1 - 10 of 29
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 8, 2018
Company News

Management tracks: As Akcea shifts to commercialization, Crooke resigns from board

...Ansun BioPharma Inc. (San Diego, Calif.) hired Stanley Lewis as CMO. He was CMO of TaiMed Biologics Inc....
BioCentury | Apr 6, 2018
Finance

Fundamentally driven

...moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy Theratechnologies Inc. (TSX:TH) / TaiMed Biologics Inc....
BioCentury | Mar 9, 2018
Clinical News

FDA approves mAb for multidrug-resistant HIV

...therapies. Theratechnologies Inc. (TSX:TH), which has U.S. rights to market and distribute the drug from TaiMed Biologics Inc....
...a month ahead of Trogarzo's PDUFA date, which FDA had extended to review manufacturing information TaiMed...
...first biologic manufactured in China to receive FDA clearance for U.S. use under an IND. TaiMed's...
BioCentury | Mar 7, 2018
Company News

WuXi Biologics, TaiMed rise after FDA approves mAb for HIV

...in China that FDA has approved (see BioCentury Extra, March 6) . WuXi Biologics' partner TaiMed Biologics Inc....
...TSX:TH), which has U.S. rights to market and distribute the drug under a deal with TaiMed...
...Priority Review, and has Fast Track, breakthrough therapy and Orphan Drug status to treat HIV. Paul Bonanos ibalizumab TaiMed Biologics Inc. Theratechnologies...
BioCentury | Mar 6, 2018
Company News

FDA approves mAb for multidrug-resistant HIV

...therapies. Theratechnologies Inc. (TSX:TH), which has U.S. rights to market and distribute the drug from TaiMed Biologics Inc....
...a month ahead of Trogarzo's PDUFA date, which FDA had extended to review manufacturing information TaiMed...
...first biologic manufactured in China to receive FDA clearance for U.S. use under an IND. TaiMed's...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...Aviv:TEVA) / Pfizer Inc. (NYSE:PFE) Fremanezumab Prevent migraine PDUFA date Mid-2018 Theratechnologies Inc. (TSX:TH) / TaiMed Biologics Inc....
BioCentury | Nov 30, 2017
Clinical News

FDA extends PDUFA for Theratechnologies' ibalizumab to treat HIV

...Theratechnologies Inc. (TSX:TH) and TaiMed Biologics Inc. (TPEx:4147) said FDA extended by 3 months the PDUFA date for...
...Theratechnologies said FDA extended the date to allow time to review manufacturing information submitted by TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
BioCentury | Aug 16, 2017
Clinical News

TaiMed's ibalizumab gets FDA Priority Review for HIV

...for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. Its PDUFA date is Jan. 3, 2018. TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
...Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHBBY) (see BioCentury, Sept. 24, 2007 ). In 2016, TaiMed...
BioCentury | May 12, 2017
Clinical News

TaiMed submits BLA to FDA for HIV candidate ibalizumab

...Inc. (TPEx:4147) submitted a BLA to FDA for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. TaiMed...
...prevents viral entry. It has breakthrough therapy and Orphan Drug designations to treat HIV, and TaiMed...
...receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014 ). TaiMed...
Items per page:
1 - 10 of 29