BioCentury | Apr 10, 2021
Product Development

Bispecific constructs move beyond T cell engagers at AACR

T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. ...
BioCentury | Apr 8, 2021
Distillery Therapeutics

PON-2 identified as B cell-ALL target

DISEASE CATEGORY: Cancer INDICATION: Acute lymphoblastic leukemia (ALL) Inhibiting PON2, a lactonase, could treat B cell ALL (B-ALL). Levels of PON2 mRNA were higher in Philadelphia chromosome-positive B-ALL cells from patients than in normal pre-B cells,...
BioCentury | Mar 27, 2021
Product Development

What it will take to meet CEPI’s 100-day vaccine goal for the next pandemic

As CEPI looks to prepare for the next pandemic, it has set a lofty goal to reduce to 100 days the time from sequencing the pathogen to a regulatory submission of a vaccine. But meeting...
BioCentury | Mar 26, 2021
Politics, Policy & Law

Abernethy tackled ‘the blooming obvious’ at FDA by improving tech and data

When Amy Abernethy joined FDA as principal deputy commissioner, “there were two things that were just blooming obvious,” she told BioCentury as she prepared to wind up a two-year stint at the agency....
BioCentury | Mar 24, 2021
Emerging Company Profile

Dunad: Expanding protein degradation beyond E3 ligase

Dunad has emerged from a year in stealth with a platform that the U.K. company believes could offer a simpler mechanism for degrading protein targets.  One of the primary differentiating features...
BioCentury | Mar 19, 2021
Product Development

Self-amplifying may be the next frontier in RNA therapies

With the success of mRNA vaccines for COVID-19 solidifying the technology as a vaccine modality that’s here to stay, the conversation has turned to where mRNA will make its mark next and what’s...
BioCentury | Mar 17, 2021
Product Development

March 17 Quick Takes: FDA extends review of Rinvoq in psoriatic arthritis; plus Merck, PharmaEssentia, Lilly, Roche and more

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an sNDA for Rinvoq upadacitinib to treat adult patients with active psoriatic arthritis after the agency had requested additional information on the oral...
BioCentury | Mar 16, 2021
Politics, Policy & Law

FTC’s ‘aggressive’ new approach to pharma merger regulation will include biotech M&A

Under the Biden administration, the U.S. Federal Trade Commission will more aggressively investigate, and may block, proposed mergers of pharmaceutical companies. While mergers of large drug companies will be subject to intensified scrutiny, the commission...
BioCentury | Mar 10, 2021
Deals

I-Mab signs first two deals of immuno-oncology discovery initiative

I-Mab’s deals with Complix and Shanghai Affinity mark the start of a new discovery initiative to build out the Chinese biotech’s immuno-oncology pipeline.  I-Mab Biopharma (NASDAQ:IMAB) said Wednesday it partnered with Belgian biotech Complix N.V....
BioCentury | Mar 6, 2021
Product Development

The pace of new modality approvals is picking up

Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to...
Items per page:
1 - 10 of 3568
BioCentury | Apr 10, 2021
Product Development

Bispecific constructs move beyond T cell engagers at AACR

T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. ...
BioCentury | Apr 8, 2021
Distillery Therapeutics

PON-2 identified as B cell-ALL target

DISEASE CATEGORY: Cancer INDICATION: Acute lymphoblastic leukemia (ALL) Inhibiting PON2, a lactonase, could treat B cell ALL (B-ALL). Levels of PON2 mRNA were higher in Philadelphia chromosome-positive B-ALL cells from patients than in normal pre-B cells,...
BioCentury | Mar 27, 2021
Product Development

What it will take to meet CEPI’s 100-day vaccine goal for the next pandemic

As CEPI looks to prepare for the next pandemic, it has set a lofty goal to reduce to 100 days the time from sequencing the pathogen to a regulatory submission of a vaccine. But meeting...
BioCentury | Mar 26, 2021
Politics, Policy & Law

Abernethy tackled ‘the blooming obvious’ at FDA by improving tech and data

When Amy Abernethy joined FDA as principal deputy commissioner, “there were two things that were just blooming obvious,” she told BioCentury as she prepared to wind up a two-year stint at the agency....
BioCentury | Mar 24, 2021
Emerging Company Profile

Dunad: Expanding protein degradation beyond E3 ligase

Dunad has emerged from a year in stealth with a platform that the U.K. company believes could offer a simpler mechanism for degrading protein targets.  One of the primary differentiating features...
BioCentury | Mar 19, 2021
Product Development

Self-amplifying may be the next frontier in RNA therapies

With the success of mRNA vaccines for COVID-19 solidifying the technology as a vaccine modality that’s here to stay, the conversation has turned to where mRNA will make its mark next and what’s...
BioCentury | Mar 17, 2021
Product Development

March 17 Quick Takes: FDA extends review of Rinvoq in psoriatic arthritis; plus Merck, PharmaEssentia, Lilly, Roche and more

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an sNDA for Rinvoq upadacitinib to treat adult patients with active psoriatic arthritis after the agency had requested additional information on the oral...
BioCentury | Mar 16, 2021
Politics, Policy & Law

FTC’s ‘aggressive’ new approach to pharma merger regulation will include biotech M&A

Under the Biden administration, the U.S. Federal Trade Commission will more aggressively investigate, and may block, proposed mergers of pharmaceutical companies. While mergers of large drug companies will be subject to intensified scrutiny, the commission...
BioCentury | Mar 10, 2021
Deals

I-Mab signs first two deals of immuno-oncology discovery initiative

I-Mab’s deals with Complix and Shanghai Affinity mark the start of a new discovery initiative to build out the Chinese biotech’s immuno-oncology pipeline.  I-Mab Biopharma (NASDAQ:IMAB) said Wednesday it partnered with Belgian biotech Complix N.V....
BioCentury | Mar 6, 2021
Product Development

The pace of new modality approvals is picking up

Last week’s FDA approval of Sarepta’s Amondys 45 marks the ninth new modality drug to be approved in the last year, a sign that the pace of new therapeutic formats making it to...
Items per page:
1 - 10 of 3568