BioCentury | Apr 21, 2021
Product Development

EMA adds warning to J&J’s COVID-19 vaccine, says data insufficient to determine cause of rare clotting

Although the safety warning EMA is adding to the Johnson & Johnson COVID-19 vaccine is similar to the warning it mandated for another adenoviral vector COVID-19 vaccine, AstraZeneca’s Vaxzevria — and...
BioCentury | Apr 21, 2021
Product Development

Synthetic lethality’s second wind

...for its DDR programs targeting WEE1 and CDC7...
BioCentury | Apr 20, 2021
Product Development

COVID roundup: FDA inspecting Emergent facility as manufacturing halted; plus J&J, WHO, Sputnik V and NIH

FDA will weigh in on when Emergent BioSolutions Inc. (NYSE:EBS) can resume manufacturing of COVID-19 vaccines, including one from Johnson & Johnson (NYSE:JNJ), at the company’s Bayview facility in Baltimore, after it concludes an inspection...
BioCentury | Apr 17, 2021
Politics, Policy & Law

White House’s latest COVID funding takes aim at variants, supports bioinformatics, centers for genomic epidemiology

The Biden administration announced Friday investments to address the threats posed by SARS-CoV-2 variants by expanding genomic sequencing, creating new genomic epidemiology R&D centers, and building and supporting a national bioinformatics infrastructure. Genomic sequencing of...
BioCentury | Apr 17, 2021
Product Development

April 16 COVID-19 Quick Takes: ACIP to reconvene over J&J’s vaccine on April 23; plus Gilead, Lilly-AbCellera and Sputnik V

The CDC’s Advisory Committee on Immunization Practices will hold a virtual emergency meeting on April 23 to discuss the use of Johnson & Johnson’s vaccine. The committee may issue updated recommendations for the vaccine’s use...
BioCentury | Apr 17, 2021
Product Development

How COVID vaccines might be causing blood clots with low platelets

Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the...
BioCentury | Apr 16, 2021
Targets & Mechanisms

New targets featured at AACR signal growing opportunity in established mechanisms

The bulk of the new targets presented at AACR21 involve pathways and mechanisms active in tumor cells rather than immune cells, reflecting the biotech industry’s growing interest in targeted oncology and...
BioCentury | Apr 15, 2021
Product Development

Next-generation DNA damage response programs at AACR

...Clinical readouts for WEE1 inhibitors, next-generation compounds against PARP and a pair of agents targeting CDC7...
...DNA. The meeting also featured presentations on preclinical compounds targeting next-wave DDR targets: PARG, USP1 and CDC7...
...PARP inhibitors.  TARGETSATM - Ataxia telangiectasia mutatedATR (FRP1) - Ataxia telangiectasia and Rad3 related CDC7- Cell division cycle 7-related protein kinase...
BioCentury | Apr 13, 2021
Product Development

FDA’s ‘pause’ could lead to narrowed indication for J&J COVID-19 vaccine

FDA’s non-binding decision to recommend a “pause” in the use of Johnson & Johnson’s COVID-19 vaccine was among the least strenuous measures it could have taken in response to adverse event reports. The action, which...
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

BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) are preparing to submit a BLA to FDA for the partners’ COVID-19 vaccine after reporting six-month efficacy data for BNT162b2. The partners, which did not specify a time frame for the submission,...
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