BioCentury | Apr 13, 2021
Product Development

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

...The PDUFA date for the antibody-drug conjugate targeting TF is Oct. 10. FDA extends review of Pfizer’s...
...JAK inhibitor Xeljanz/Xeljanz XR tofacitinib to treat active ankylosing spondylitis by three months to 3Q21. Pfizer...
...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 Inc. Genmab A/S Pfizer Inc. Gilead...
BioCentury | Apr 12, 2021
Product Development

COVID Quick Takes: subcutaneous Regeneron mAbs prevent symptomatic COVID; plus Pfizer-BionTech, J&J, Akili and Kiniksa

...REGEN-COV, REGN-COV2, REGN-COVID19, REGN10933/REGN10987) Covid 19 Vx, Comirnaty, Pfizer-BioNTech...
...Vaccine Janssen (Ad26.COV2.S, JNJ-78436735) mavrilimumab (cam-3001) AKL-T01, SDT-001 Regeneron Pharmaceuticals Inc. Pfizer Inc. BioNTech...
BioCentury | Apr 12, 2021
Politics, Policy & Law

Cavazzoni brings competence, continuity as CDER director

...global pharmacovigilance and epidemiology at Sanofi (Euronext:SAN; NASDAQ:SNY). After six months at Sanofi, Cavazzoni joined Pfizer Inc....
...worldwide safety strategy. She was SVP, head of clinical sciences & operations when she left Pfizer...
...how the center should adopt lessons learned from the experience. Steve Usdin U.S. Food and Drug Administration (FDA) Pfizer Inc. Eli...
BioCentury | Apr 9, 2021
Management Tracks

Bryce joins Rain as CMO; plus Ichnos, Dementia Discovery Fund, Akoya and more

...Mansell as SVP and head of regulatory affairs. Most recently, McCormac was executive director at Pfizer Inc....
BioCentury | Apr 7, 2021
Distillery Therapeutics

eIF4E identified as target in obesity, fatty liver disease

...cell lymphomas and a variety of solid tumors.Pfizer Inc....
BioCentury | Apr 7, 2021
Product Development

FDA could delay decision on AstraZeneca COVID-19 vaccine

...former HHS officials told BioCentury. The precedents set with the first three COVID-19 vaccines from Pfizer Inc....
...outweigh its risks. On Wednesday, MHRA recommended that individuals ages 18-30 be offered Comirnaty from Pfizer...
...receiving Vaxzevria. Associate Editor Paul Bonanos and Assistant Editor Sandi Wong contributed to this story. Steve Usdin AstraZeneca plc Pfizer Inc. BioNTech...
BioCentury | Apr 7, 2021
Management Tracks

Takeda’s Koo to lead Overland-ADC joint venture; plus Precision, Amryt, Bridge, Opthea and Cogent

...John Robinson as CSO to lead the newly formed Cogent research team. Robinson joins from Pfizer Inc....
BioCentury | Apr 7, 2021
Product Development

Latest cut of data shows AZ vaccine has higher rates of rare thrombosis

...59.8 million administered doses of Comirnaty (BNT162b2) from Pfizer Inc....
BioCentury | Apr 1, 2021
Product Development

COVID roundup: BioNTech-Pfizer vaccine protects adolescents; plus AZ, GSK-Novavax and Amazon

...By BioCentury Staff BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) plan to request Comirnaty (BNT162b2) emergency use...
...ChAdOx1 nCoV-19) NVX-CoV2373 Covid 19 Vx, Comirnaty, Pfizer-BioNTech COVID-19 Vaccine (PF-07302048, BNT162, BNT162b2) AstraZeneca plc GlaxoSmithKline plc Novavax Inc. Amazon.com Inc. BioNTech SE Pfizer Inc. covid-19 covid19 cov19count cov19dx cov19count...
BioCentury | Apr 1, 2021
Product Development

April 1 Quick Takes: BioNTech, Pfizer to seek full approval of vaccine; plus CEPI’s call and FDA’s latest batch of expanded labels

...By BioCentury Staff BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) are preparing to submit a BLA to FDA...
...SAR236553 (Compound #), REGN727 (Compound #), alirocumab (Generic), Praluent (Other) Coalition for Epidemic Preparedness Innovations (CEPI) BioNTech SE Pfizer Inc. Regeneron...
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BioCentury | Apr 13, 2021
Product Development

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

...The PDUFA date for the antibody-drug conjugate targeting TF is Oct. 10. FDA extends review of Pfizer’s...
...JAK inhibitor Xeljanz/Xeljanz XR tofacitinib to treat active ankylosing spondylitis by three months to 3Q21. Pfizer...
...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 Inc. Genmab A/S Pfizer Inc. Gilead...
BioCentury | Apr 12, 2021
Product Development

COVID Quick Takes: subcutaneous Regeneron mAbs prevent symptomatic COVID; plus Pfizer-BionTech, J&J, Akili and Kiniksa

...REGEN-COV, REGN-COV2, REGN-COVID19, REGN10933/REGN10987) Covid 19 Vx, Comirnaty, Pfizer-BioNTech...
...Vaccine Janssen (Ad26.COV2.S, JNJ-78436735) mavrilimumab (cam-3001) AKL-T01, SDT-001 Regeneron Pharmaceuticals Inc. Pfizer Inc. BioNTech...
BioCentury | Apr 12, 2021
Politics, Policy & Law

Cavazzoni brings competence, continuity as CDER director

...global pharmacovigilance and epidemiology at Sanofi (Euronext:SAN; NASDAQ:SNY). After six months at Sanofi, Cavazzoni joined Pfizer Inc....
...worldwide safety strategy. She was SVP, head of clinical sciences & operations when she left Pfizer...
...how the center should adopt lessons learned from the experience. Steve Usdin U.S. Food and Drug Administration (FDA) Pfizer Inc. Eli...
BioCentury | Apr 9, 2021
Management Tracks

Bryce joins Rain as CMO; plus Ichnos, Dementia Discovery Fund, Akoya and more

...Mansell as SVP and head of regulatory affairs. Most recently, McCormac was executive director at Pfizer Inc....
BioCentury | Apr 7, 2021
Distillery Therapeutics

eIF4E identified as target in obesity, fatty liver disease

...cell lymphomas and a variety of solid tumors.Pfizer Inc....
BioCentury | Apr 7, 2021
Product Development

FDA could delay decision on AstraZeneca COVID-19 vaccine

...former HHS officials told BioCentury. The precedents set with the first three COVID-19 vaccines from Pfizer Inc....
...outweigh its risks. On Wednesday, MHRA recommended that individuals ages 18-30 be offered Comirnaty from Pfizer...
...receiving Vaxzevria. Associate Editor Paul Bonanos and Assistant Editor Sandi Wong contributed to this story. Steve Usdin AstraZeneca plc Pfizer Inc. BioNTech...
BioCentury | Apr 7, 2021
Management Tracks

Takeda’s Koo to lead Overland-ADC joint venture; plus Precision, Amryt, Bridge, Opthea and Cogent

...John Robinson as CSO to lead the newly formed Cogent research team. Robinson joins from Pfizer Inc....
BioCentury | Apr 7, 2021
Product Development

Latest cut of data shows AZ vaccine has higher rates of rare thrombosis

...59.8 million administered doses of Comirnaty (BNT162b2) from Pfizer Inc....
BioCentury | Apr 1, 2021
Product Development

COVID roundup: BioNTech-Pfizer vaccine protects adolescents; plus AZ, GSK-Novavax and Amazon

...By BioCentury Staff BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) plan to request Comirnaty (BNT162b2) emergency use...
...ChAdOx1 nCoV-19) NVX-CoV2373 Covid 19 Vx, Comirnaty, Pfizer-BioNTech COVID-19 Vaccine (PF-07302048, BNT162, BNT162b2) AstraZeneca plc GlaxoSmithKline plc Novavax Inc. Amazon.com Inc. BioNTech SE Pfizer Inc. covid-19 covid19 cov19count cov19dx cov19count...
BioCentury | Apr 1, 2021
Product Development

April 1 Quick Takes: BioNTech, Pfizer to seek full approval of vaccine; plus CEPI’s call and FDA’s latest batch of expanded labels

...By BioCentury Staff BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) are preparing to submit a BLA to FDA...
...SAR236553 (Compound #), REGN727 (Compound #), alirocumab (Generic), Praluent (Other) Coalition for Epidemic Preparedness Innovations (CEPI) BioNTech SE Pfizer Inc. Regeneron...
Items per page:
1 - 10 of 10176