BioCentury | Feb 19, 2020
Regulation

Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label. The agency will consider granting accelerated approval to Xpovio selinexor to...
BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BioCentury | Feb 13, 2020
Finance

Vivo-led $105M round to spur development of ALX’s CD47

Encouraged by safety data for ALX’s CD47-targeted cancer therapy, Vivo Capital led the biotech’s $105 million series C Wednesday to fuel its clinical catch-up to its most advanced competitor. Other new investors including funds managed...
BioCentury | Feb 13, 2020
Finance

Vivo-led $105M round to spur ALX’s CD47

Encouraged by safety data for ALX’s CD47-targeted cancer therapy, Vivo Capital led the biotech’s $105 million series C Wednesday to fuel its clinical catch-up to its most advanced competitor. Other new investors including funds managed...
BioCentury | Feb 12, 2020
Emerging Company Profile

Volastra raises $12M seed led by Polaris to shut down metastasis

A trio of Weill Cornell and Sloan Kettering researchers have launched Volastra with $12 million in seed funding to develop therapies targeting chromosomal instability -- a driver of cancer metastasis. Polaris Partners led the seed...
BioCentury | Feb 8, 2020
Tools & Techniques

Beyond PROTACs and the proteasome: broadening the TAC toolbox

The idea of sending disease-driving proteins to the cell’s garbage can is only the first act in a field that now centers around targeted degradation. In the sequel, researchers are extending the principle to other...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
BioCentury | Jan 28, 2020
Distillery Therapeutics

Inhibiting CD36 to overcome resistance to Tykerb in HER2-positive breast cancer

DISEASE CATEGORY: Cancer INDICATION: Breast cancer Inhibiting CD36, a fatty acid transporter, could treat HER2-positive breast cancer and sensitize tumors resistant to Tykerb lapatinib. In patients with HER2-positive breast cancer, CD36 protein levels were higher...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BioCentury | Jan 25, 2020
Product Development

Radiotherapy blasts forward

High-wattage takeouts and commercial launches have revived interest in radiopharmaceuticals for cancer. The challenge for the new wave of candidates is to achieve enough differentiation to justify the logistical hurdles of manufacturing and delivering products...
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