BioCentury | Mar 17, 2020
Product Development

Phase II data bring Blueprint closer to major market expansion for Ayvakit

With positive initial data for Ayvakit in indolent systemic mastocytosis, Blueprint is moving into position to expand its only approved drug into a much larger patient population while sticking to its strategy of focusing on...
BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

Boehringer’s Ofev approved as first therapy for lung scarring disease  FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH as the first therapy for chronic fibrosing interstitial lung diseases; the NDA had received Priority Review. The...
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 | Jan 25, 2020
Emerging Company Profile

Aluda: targeting the fundamentals

Five years after its launch, Aluda is pulling back the curtain on its pipeline, leading with a first-in-class anti-VIM therapy for fibrotic indications. CEO Ruihuan Chen co-founded Aluda Pharmaceuticals Inc. in 2015 after 13 years...
BC Extra | Jan 24, 2020
Financial News

January fund-raising sets pace with $2.6B in follow-ons

A series of follow-ons pushed biotechs to raise about $1.5 billion this week, bringing January's total raise to about $2.6 billion via 16 follow-ons. The offerings have already outpaced last January, which saw $1.7 billion...
BC Extra | Jan 9, 2020
Company News

Blueprint gets first FDA approval, with second expected this year

FDA approved Blueprint’s gastrointestinal stromal tumor therapy a month ahead of its Feb. 14 PDUFA date, notching the biotech the first of two expected approvals this year. Ayvakit avapritinib from Blueprint Medicines Corp. (NASDAQ:BPMC) is...
BC Extra | Jan 8, 2020
Company News

Pralsetinib data puts Blueprint on track for two FDA decisions this year

Blueprint moved a step closer to having two precision cancer therapies approved this year after announcing it started a rolling submission of an NDA for RET inhibitor pralsetinib along with updated Phase I/II data. Blueprint...
BC Extra | Dec 16, 2019
Clinical News

Novartis’ asthma failure weighs on Gossamer’s shares ahead of readout

The latest failure of asthma therapy fevipiprant from Novartis in two Phase III studies dimmed hopes for Gossamer’s lead program, which aims for the same target. Novartis AG (NYSE:NVS; SIX:NOVN) said Monday that pooled results...
BC Extra | Dec 10, 2019
Clinical News

Dec. 9 ASH Quick Takes: Kite, Principia, Blueprint, Precision and Rocket

Kite plans marketing applications for CD19 CAR T on pivotal MCL data  Kite Pharma Inc. reported a 93% best objective response rate including a 67% complete response rate -- secondary endpoints -- in 60 evaluable...
BC Extra | Oct 29, 2019
Company News

Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

Galapagos, MorphoSys, Novartis discontinue atopic dermatitis program  With an interim analysis indicating futility of the Phase II IGUANA trial, MorphoSys AG (Xetra:MOR; NASDAQ:MOR), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) and Novartis AG (NYSE:NVS; SIX:NOVN) terminated development of...
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