BioCentury | Apr 13, 2021
Product Development

FDA requests more data from Provention; plus Iterum, Seagen-Genmab, Pfizer and Gilead

...committee meeting to discuss the BLA on May 27. Adcomm for Iterum’s UTI candidate postponedAntibiotic play Iterum Therapeutics plc...
...transducer 2 BC Staff Sulopenem etzadroxil-probenecid (PF-03709270) HuMax-TF-ADC, tisotumab vedotin abrocitinib (PF-04965842) Xeljanz XR, tofacitinib extended release Trodelvy, sacituzumab govitecan (hRS7-SN-38, IMMU-132) Iterum Therapeutics plc Seagen...
BioCentury | Jan 26, 2021
Regulation

Jan. 25 Quick Takes: Comirnaty approved in Australia, authorized in Hong Kong; plus Albireo, Iterum and AZ

...review to Iterum’s NDA for antibioticFDA granted priority review to an NDA for Sulopenem etzadroxil-probenecid from Iterum Therapeutics plc...
...in patients with a quinolone non-susceptible pathogen. The antibiotic has a July 25 PDUFA date. Iterum...
...Group Co. Ltd. Montreal Heart Institute Albireo Pharma Inc. U.S. Food and Drug Administration (FDA) Johnson & Johnson AbbVie Inc. BioNTech SE Iterum Therapeutics plc AstraZeneca...
BioCentury | Dec 11, 2019
Clinical News

Iterum antibiotic fails in Phase III for intra-abdominal infections, further driving down shares

...narrower difference in clinical response rates between the two antibiotics than the primary analysis showed. Iterum Therapeutics plc...
...vs. 85.3% for Invanz (95% CI: -0.081, 0.045). Even if the antibiotic gains market approval, Iterum...
...still struggle. Multiple antibiotics companies with recently approved drugs have had difficulty turning a profit. Iterum...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...Lilly and Co. (NYSE:LLY) Tanezumab Osteoarthritis (OA) pain Submit NDA 2H19 Pfizer Inc. (NYSE:PFE) / Iterum Therapeutics plc...
...and complicated intra-abdominal infections Phase III data; submit NDA 2H19; YE19 Pfizer Inc. (NYSE:PFE) / Iterum Therapeutics plc...
BioCentury | Dec 13, 2018
Company News

Management tracks: Tamura reclaims CEO role at Sosei

...hired Sailaja Puttagunta as CMO, a newly created position. She was VP of development at Iterum Therapeutics plc...
BioCentury | Jul 13, 2018
Finance

Pause for politics

...NASDAQ:VRCA) 6/14/18 $86.3 $385.4 $485.1 26% MeiraGTx Holdings plc (NASDAQ:MGTX) 6/7/18 $75.0 $407.8 $286.2 -30% Iterum Therapeutics plc...
BioCentury | May 25, 2018
Financial News

Anti-infectives play Iterum raises $80M in IPO

...by Leerink, RBC Capital Markets, Guggenheim and Needham. The price values Iterum at $181.5 million. Iterum...
...at $181.5 million. Iterum slid $0.15 to $12.85 on Friday, its first day of trading. Iterum...
...$15 would have raised $80 million and valued the company at $197.1 million. Next half, Iterum...
BioCentury | May 18, 2018
Finance

China comes to Europe

...one U.S.-based investor, with three biotechs -- gene therapy play Orchard Therapeutics Ltd., antibiotics company Iterum...
...Invesco , Woodford Investment Management, Touchstone Innovations plc T cell therapies Cancer and infectious diseases Iterum...
...Healthcare Investments, Agent Capital, ORI Capital, Juda Capital, 4BIO Capital Gene therapy Inherited rare diseases Iterum...
BioCentury | May 18, 2018
Financial News

Iterum sets IPO range

...Antibiotics company Iterum Therapeutics plc (Dublin, Ireland) amended its proposed IPO on NASDAQ on May 16 and now...
...the offering, which is being underwritten by Leerink, RBC, Guggenheim and Needham. Iterum Therapeutics plc, Dublin, Ireland Shannon Lehnbeuter Iterum Therapeutics plc...
BioCentury | May 17, 2018
Finance

Europe’s piece of the pie

...almost $300 million in public financing. The gene therapy companies include Orchard Therapeutics Ltd. and Iterum...
...Ltd. (SIX:IDIA), Allschwil, Switzerland Immatics Biotechnologies GmbH, Tübingen, Germany Innovative Medicines Initiative (IMI), Brussels, Belgium Iterum...
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1 - 10 of 23
BioCentury | Apr 13, 2021
Product Development

FDA requests more data from Provention; plus Iterum, Seagen-Genmab, Pfizer and Gilead

...committee meeting to discuss the BLA on May 27. Adcomm for Iterum’s UTI candidate postponedAntibiotic play Iterum Therapeutics plc...
...transducer 2 BC Staff Sulopenem etzadroxil-probenecid (PF-03709270) HuMax-TF-ADC, tisotumab vedotin abrocitinib (PF-04965842) Xeljanz XR, tofacitinib extended release Trodelvy, sacituzumab govitecan (hRS7-SN-38, IMMU-132) Iterum Therapeutics plc Seagen...
BioCentury | Jan 26, 2021
Regulation

Jan. 25 Quick Takes: Comirnaty approved in Australia, authorized in Hong Kong; plus Albireo, Iterum and AZ

...review to Iterum’s NDA for antibioticFDA granted priority review to an NDA for Sulopenem etzadroxil-probenecid from Iterum Therapeutics plc...
...in patients with a quinolone non-susceptible pathogen. The antibiotic has a July 25 PDUFA date. Iterum...
...Group Co. Ltd. Montreal Heart Institute Albireo Pharma Inc. U.S. Food and Drug Administration (FDA) Johnson & Johnson AbbVie Inc. BioNTech SE Iterum Therapeutics plc AstraZeneca...
BioCentury | Dec 11, 2019
Clinical News

Iterum antibiotic fails in Phase III for intra-abdominal infections, further driving down shares

...narrower difference in clinical response rates between the two antibiotics than the primary analysis showed. Iterum Therapeutics plc...
...vs. 85.3% for Invanz (95% CI: -0.081, 0.045). Even if the antibiotic gains market approval, Iterum...
...still struggle. Multiple antibiotics companies with recently approved drugs have had difficulty turning a profit. Iterum...
BioCentury | Jan 5, 2019
Finance

Ready to launch

...Lilly and Co. (NYSE:LLY) Tanezumab Osteoarthritis (OA) pain Submit NDA 2H19 Pfizer Inc. (NYSE:PFE) / Iterum Therapeutics plc...
...and complicated intra-abdominal infections Phase III data; submit NDA 2H19; YE19 Pfizer Inc. (NYSE:PFE) / Iterum Therapeutics plc...
BioCentury | Dec 13, 2018
Company News

Management tracks: Tamura reclaims CEO role at Sosei

...hired Sailaja Puttagunta as CMO, a newly created position. She was VP of development at Iterum Therapeutics plc...
BioCentury | Jul 13, 2018
Finance

Pause for politics

...NASDAQ:VRCA) 6/14/18 $86.3 $385.4 $485.1 26% MeiraGTx Holdings plc (NASDAQ:MGTX) 6/7/18 $75.0 $407.8 $286.2 -30% Iterum Therapeutics plc...
BioCentury | May 25, 2018
Financial News

Anti-infectives play Iterum raises $80M in IPO

...by Leerink, RBC Capital Markets, Guggenheim and Needham. The price values Iterum at $181.5 million. Iterum...
...at $181.5 million. Iterum slid $0.15 to $12.85 on Friday, its first day of trading. Iterum...
...$15 would have raised $80 million and valued the company at $197.1 million. Next half, Iterum...
BioCentury | May 18, 2018
Finance

China comes to Europe

...one U.S.-based investor, with three biotechs -- gene therapy play Orchard Therapeutics Ltd., antibiotics company Iterum...
...Invesco , Woodford Investment Management, Touchstone Innovations plc T cell therapies Cancer and infectious diseases Iterum...
...Healthcare Investments, Agent Capital, ORI Capital, Juda Capital, 4BIO Capital Gene therapy Inherited rare diseases Iterum...
BioCentury | May 18, 2018
Financial News

Iterum sets IPO range

...Antibiotics company Iterum Therapeutics plc (Dublin, Ireland) amended its proposed IPO on NASDAQ on May 16 and now...
...the offering, which is being underwritten by Leerink, RBC, Guggenheim and Needham. Iterum Therapeutics plc, Dublin, Ireland Shannon Lehnbeuter Iterum Therapeutics plc...
BioCentury | May 17, 2018
Finance

Europe’s piece of the pie

...almost $300 million in public financing. The gene therapy companies include Orchard Therapeutics Ltd. and Iterum...
...Ltd. (SIX:IDIA), Allschwil, Switzerland Immatics Biotechnologies GmbH, Tübingen, Germany Innovative Medicines Initiative (IMI), Brussels, Belgium Iterum...
Items per page:
1 - 10 of 23