BioCentury | Mar 2, 2021
Regulation

Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on...
BioCentury | Feb 27, 2021
Deals

Feb. 26 Quick Takes: Venrock leads Artiva’s crossover-laden $120M series B; plus Roivant-Silicon, Origin, Sino-Akeso, Tricida, LISCure

...anti-PD-1 mAb penpulimab (AK105) from Sino Biopharmaceutical Ltd. (HKEX:1177) and Akeso Inc. (HKEX:9926) plus chemotherapy met the primary endpoint...
BioCentury | Feb 24, 2021
Product Development

U.K. RECOVERY trial’s expansion to Asia, Africa sites offers access to broader scope of patients, ‘safety net’

By expanding into sites outside the U.K., the RECOVERY master protocol trial will be able to evaluate the efficacy of repurposed and investigational COVID-19 therapies in populations with less background healthcare treatment and different co-morbidities. ...
BioCentury | Feb 24, 2021
Product Development

Feb. 23 Quick Takes: Hold for bluebird; plus priority review for Pfizer’s TicoVac and updates from Taiho and NeuroRx

...in August.Taiho’s pimitespib meets in GIST studyPimitespib (TAS-116) from Taiho Pharmaceutical Co. Ltd. met the primary endpoint...
BioCentury | Feb 23, 2021
Management Tracks

Kite’s Takeshita to head R&D for Daiichi Sankyo; plus TScan adds CFO Silver, Hahn joins Blackfynn’s board and moves at Intercept, Kira, Insilico, BioXcel and Re-Vana

Kite Pharma veteran Ken Takeshita will join Daiichi Sankyo Co. Ltd. (Tokyo:4568) as global head of R&D, succeeding Junichi Koga, who is retiring after more than a dozen years at the Japanese pharma. Kite, a unit of Gilead...
BioCentury | Feb 23, 2021
Product Development

FDA’s Marks says time is now to start trials for vaccines against new COVID-19 variants as agency issues guidance

...companies to forgo the large clinical efficacy endpoint-driven...
...to the large Phase III clinical efficacy endpoint-driven...
BioCentury | Feb 23, 2021
Product Development

Meniere disease pipeline: Data Byte

...announced Monday that Otividex, its sustained-release dexamethasone gel, which targets GCCR, missed its Phase III primary endpoint...
BioCentury | Feb 22, 2021
Product Development

Otonomy looking beyond Meniere disease after latest Phase III miss

...second time in Phase III testing, providing a basis for registration.Otividex missed the trial’s primary endpoint...
...shown mixed results in two prior late-stage trials. In 2017, it had met the primary endpoint...
...Phase III AVERTS-2 trial by reducing the number of days experiencing vertigo, but missed the endpoint...
BioCentury | Feb 22, 2021
Management Tracks

Fresh from $21B Gilead deal, Immunomedics vet Malik to lead newly rebranded precision medicines company Fore

Israeli diagnostics company Novellus has tapped former Immunomedics executive Usama Malik as its new CEO as it moves to the U.S. and rebrands as a precision therapeutics company, the newly named Fore Biotherapeutics....
BioCentury | Feb 20, 2021
Product Development

Snapshot of Phase III therapies for Alzheimer’s disease: Data Byte

Despite the giant public health need for new treatments, the Phase III pipeline for Alzheimer’s disease remains thin, with just 13 compounds in 40 trials. Four of these compounds correspond to nearly...
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1 - 10 of 53303
BioCentury | Mar 2, 2021
Regulation

Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on...
BioCentury | Feb 27, 2021
Deals

Feb. 26 Quick Takes: Venrock leads Artiva’s crossover-laden $120M series B; plus Roivant-Silicon, Origin, Sino-Akeso, Tricida, LISCure

...anti-PD-1 mAb penpulimab (AK105) from Sino Biopharmaceutical Ltd. (HKEX:1177) and Akeso Inc. (HKEX:9926) plus chemotherapy met the primary endpoint...
BioCentury | Feb 24, 2021
Product Development

U.K. RECOVERY trial’s expansion to Asia, Africa sites offers access to broader scope of patients, ‘safety net’

By expanding into sites outside the U.K., the RECOVERY master protocol trial will be able to evaluate the efficacy of repurposed and investigational COVID-19 therapies in populations with less background healthcare treatment and different co-morbidities. ...
BioCentury | Feb 24, 2021
Product Development

Feb. 23 Quick Takes: Hold for bluebird; plus priority review for Pfizer’s TicoVac and updates from Taiho and NeuroRx

...in August.Taiho’s pimitespib meets in GIST studyPimitespib (TAS-116) from Taiho Pharmaceutical Co. Ltd. met the primary endpoint...
BioCentury | Feb 23, 2021
Management Tracks

Kite’s Takeshita to head R&D for Daiichi Sankyo; plus TScan adds CFO Silver, Hahn joins Blackfynn’s board and moves at Intercept, Kira, Insilico, BioXcel and Re-Vana

Kite Pharma veteran Ken Takeshita will join Daiichi Sankyo Co. Ltd. (Tokyo:4568) as global head of R&D, succeeding Junichi Koga, who is retiring after more than a dozen years at the Japanese pharma. Kite, a unit of Gilead...
BioCentury | Feb 23, 2021
Product Development

FDA’s Marks says time is now to start trials for vaccines against new COVID-19 variants as agency issues guidance

...companies to forgo the large clinical efficacy endpoint-driven...
...to the large Phase III clinical efficacy endpoint-driven...
BioCentury | Feb 23, 2021
Product Development

Meniere disease pipeline: Data Byte

...announced Monday that Otividex, its sustained-release dexamethasone gel, which targets GCCR, missed its Phase III primary endpoint...
BioCentury | Feb 22, 2021
Product Development

Otonomy looking beyond Meniere disease after latest Phase III miss

...second time in Phase III testing, providing a basis for registration.Otividex missed the trial’s primary endpoint...
...shown mixed results in two prior late-stage trials. In 2017, it had met the primary endpoint...
...Phase III AVERTS-2 trial by reducing the number of days experiencing vertigo, but missed the endpoint...
BioCentury | Feb 22, 2021
Management Tracks

Fresh from $21B Gilead deal, Immunomedics vet Malik to lead newly rebranded precision medicines company Fore

Israeli diagnostics company Novellus has tapped former Immunomedics executive Usama Malik as its new CEO as it moves to the U.S. and rebrands as a precision therapeutics company, the newly named Fore Biotherapeutics....
BioCentury | Feb 20, 2021
Product Development

Snapshot of Phase III therapies for Alzheimer’s disease: Data Byte

Despite the giant public health need for new treatments, the Phase III pipeline for Alzheimer’s disease remains thin, with just 13 compounds in 40 trials. Four of these compounds correspond to nearly...
Items per page:
1 - 10 of 53303