BioCentury | Apr 13, 2021
Product Development

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

...application “that preclude discussion of labeling and post-marketing requirements/commitments at this time” and that additional PK/PD...
BioCentury | Mar 18, 2021
Emerging Company Profile

Through Aktis, MPM bets on radiotherapy for solid tumors

...Emerging Company Profile: Aktis raises $72M A round to develop alpha-emitting radiotherapies with differentiated PK By...
BioCentury | Mar 12, 2021
Product Development

COVID-19 Quick Takes: J&J vaccine authorized in EU as some EMA states pause AZ vaccine deployment; plus Genentech, Moderna, Novavax, Merck-Ridgeback, Atea and SerImmune

...meeting. The oral RdRP inhibitor is also in a Phase II/III trial enrolling about 1,450 patients.PK...
BioCentury | Mar 6, 2021
Emerging Company Profile

Araris: universal linkers for antibody-drug conjugates

...Spycher told BioCentury. “The ADCs have excellent PK...
BioCentury | Mar 3, 2021
Product Development

With Kymera’s clinical debut, targeted protein degradation gets its first RCT

...and use of healthy volunteers will facilitate a more comprehensive understanding of the targeted degrader’s PK/PD...
BioCentury | Feb 16, 2021
Regulation

Emerging immunotherapies need harmonization on definitions and monitoring

...to grade it, we won’t be able to advance drug discovery and advance care,” said PK...
BioCentury | Jan 27, 2021
Product Development

Leaving cancer behind, Agios preps submission after latest readout in rare anemia

...“easily has blockbuster potential across a range of hemolytic anemias,” CEO Jacqualyn Fouse said last month.PK...
BioCentury | Jan 22, 2021
Product Development

Lilly, AbCellera mAb could enable broad deployment for COVID without taxing infusion centers

...in individuals with infected household contacts. It is also running a Phase I safety and PK/PD...
BioCentury | Jan 13, 2021
Emerging Company Profile

LifeMine taps fungal genomes for new drug candidates

...therapy target and the other has a known impact on T cell biology. LifeMine is conducting ADME/PK...
BioCentury | Dec 21, 2020
Deals

Agios to exit oncology, reward investors via Servier deal as lead anemia program nears submission

...Fouse said.Mitapivat already met the primary endpoint in a Phase III trial to treat pyruvate kinase (PK...
...not transfused regularly. Results are due next quarter from a second Phase III trial in PK...
...receive regular transfusions; regulatory submissions are likely in 2021, and a launch would follow in 2022.PK...
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