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

...drugs from United Therapeutics Corp. (NASDAQ:UTHR) and Sanofi (Euronext:SAN; NASDAQ:SNY) and expanded the labels of PCSK9...
BioCentury | Mar 6, 2021
Product Development

The pace of new modality approvals is picking up

...non-orphan indication for the modality. The siRNA PCSK9...
...antigen A4 NY-ESO-1 (CTAG1B) – Cancer/testis antigen 1B PCSK9Proprotein convertase subtilisin/kexin type 9 SOD1...
BioCentury | Feb 12, 2021
Regulation

FDA approval of Regeneron’s Evkeeza brings new drug class to HoFH patients

...familial hypercholesterolemia, offering a new mechanism of action to patients who don’t respond to statins or PCSK9...
...Phase III trial were receiving maximally-tolerated lipid lowering therapy, with 98% on statins, 81% on PCSK9...
...of ELIPSE HoFH’s patients had no LDLR function, meaning they don’t respond to statin or PCSK9...
BioCentury | Jan 14, 2021
Deals

Jan. 13 Quick Takes: Takeda, KSQ enter immunotherapy deal; plus Taysha, Cardea, Esperion-Serometrix, Paion-La Jolla and more

...Esperion adds oral PCSK9 program through Serometrix dealEsperion Therapeutics Inc. (NASDAQ:ESPR) in-licensed a preclinical oral PCSK9...
...uptake due to the availability of lower cost statins. The company plans to develop the PCSK9...
...expectations of $23-$23.5 billion; it had not previously broken out its expectations for Veklury.TARGETSPCSK9Proprotein convertase subtilisin/kexin type 9 BC...
BioCentury | Jan 13, 2021
Product Development

Why Verve chose base editing over standard CRISPR for its lead CV candidate

...lead candidate VERVE-101 induced and sustained an 89% reduction in plasma levels of target protein PCSK9...
...preventative setting for high-risk individuals.Verve has not disclosed the specific A-to-G sequence change in the PCSK9...
...as “turning off the production of PCSK9 protein from liver.”Naturally occurring loss-of-function mutations in human PCSK9...
BioCentury | Jan 6, 2021
Deals

Jan. 5 Quick Takes: Myriad restructuring; plus ViGeneron-Biogen, Rhythm, Sosei and more

Myriad’s autoimmune unit on the blockMyriad Genetics Inc. (NASDAQ:MYGN) said it will focus on women’s health, cancer and mental health and pursue strategic alternatives for its autoimmune unit. In November on its earnings call, the...
BioCentury | Dec 19, 2020
Product Development

Dec. 18 Quick Takes: FDA approves expanded label for Benlysta and first oral prostate cancer therapy; plus Novartis, FibroGen, A2i, China’s NRDL and more

FDA expands Benlysta label to include lupus nephritisFDA approved Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for adults with active lupus nephritis, making it the first therapy specifically approved for the systemic lupus erythematosus complication....
BioCentury | Dec 12, 2020
Regulation

RNA therapies get another 2020 win with inclisiran approval

...hypercholesterolemia or mixed dyslipidemia.The therapy, which targets PCSK9...
...require daily oral dosing and mAbs against PCSK9...
...the factors behind their slow uptake. The PCSK9...
BioCentury | Dec 2, 2020
Distillery Therapeutics

Blocking PCSK9 alone or with anti-PD-1 therapies for cancer

...and melanoma, tumor-specific PCSK9 knockout alone reduced tumor growth and protected mice from rechallenge with PCSK9-expressing...
...NYSE:NVS; SIX:NOVN) and Silence Therapeutics plc (NASDAQ:SLN; LSE:SLN), is in registration for hypercholesterolemia and hyperlipidemia.TARGET/MARKER/PATHWAY: Proprotein convertase subtilisin/kexin type 9 (PCSK9...
...Compound #), SAR236553 (Compound #), REGN727 (Compound #), alirocumab (Generic), Praluent (Other) Duke University Medical Center Proprotein convertase subtilisin/kexin type 9 (PCSK9) Programmed...
BioCentury | Dec 1, 2020
Product Development

Nov. 30 Quick Takes: Grail piloting blood test in U.K.; plus Rhythm, Kadmon, venture rounds for Adrenomed, Xbiome, Transition

Grail piloting cancer blood test with NHS EnglandGrail Inc. announced a pilot program with NHS England using the company's Galleri blood test to monitor 140,000 asymptomatic participants aged 50 to 79 for three years, and...
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