BioCentury | Aug 1, 2020
Product Development

July 31 Quick Takes: FDA approves MorphoSys’ tafasitamab; Truvian, AbbVie, Boehringer, Lilly, Alector, Henlius-Accord, Ascletis, Roche, Merck

MorphoSys follows Kress’ first big deal with U.S. approval FDA granted accelerated approval to Monjuvi tafasitamab-cxix from MorphoSys AG (Xetra:MOR; NASDAQ:MOR) and Incyte Corp. (NASDAQ:INCY) in combination with lenalidomide to treat patients with relapsed or...
BioCentury | Jul 25, 2020
Regulation

FDA makes Gilead’s Tecartus, for mantle cell lymphoma, third U.S.-approved CAR T

Kite’s Tecartus has become the third CAR T cell therapy, after Kymriah and Yescarta, to earn FDA approval. On Friday, FDA granted accelerated approval to Tecartus brexucabtagene autoleucel from the Gilead Sciences Inc. (NASDAQ:GILD) unit...
BioCentury | Jul 24, 2020
Product Development

July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit

Priority Review for Aurinia’s lupus nephritis therapy  FDA accepted and granted Priority Review to an NDA for voclosporin from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH; TSX:AUP) to treat lupus nephritis. The PDUFA date for the immune-suppressing, IL-2-blocking...
BioCentury | Jul 14, 2020
Deals

Roche deal clears path for Blueprint’s financial independence

In the year’s largest licensing deal thus far, Blueprint has secured the resources it needs to sustain itself financially while gaining access to Roche’s diagnostic capabilities, a key driver for commercializing its targeted therapies for...
BioCentury | Jun 6, 2020
Management Tracks

COVID-19 vaccine partners Lonza and Moderna announce new execs; plus Samumed, EpicentRx, Immatics, Aligos, ImmunoGen, Ferring, Sanifit and more

Pierre-Alain Ruffieux will become CEO of Lonza Group Ltd. (SIX:LONN), effective Nov. 1. He succeeds Chairman Albert Baehny, who had been serving on an interim basis since former CEO Marc Funk stepped down in January....
BioCentury | Jun 4, 2020
Product Development

June 3 Quick Takes: Double double for BeiGene’s Brukinsa; plus Novartis, Merck-Vaxxas, Antibe, Mirum and more

BeiGene’s BTK inhibitor gets first China approval  BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) said China’s National Medical Products Administration approved Brukinsa zanubrutinib in two cancer indications: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma...
BioCentury | May 21, 2020
Product Development

May 20 Quick Takes: Filgotinib meets in ulcerative colitis; broader labels for Lynparza, Tecentriq, plus updates from Eiger, eGenesis and more

High dose filgotinib meets ulcerative colitis endpoints  A 200 mg dose of filgotinib from Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) met the primary endpoints in the placebo-controlled Phase IIb/III SELECTION trial to...
BioCentury | May 19, 2020
Product Development

May 18 Quick Takes: ChemoCentryx’s Phase II miss; plus Teva, Zai-Novocure, Lava-J&J, Sanofi, Rhythm, ViiV

ChemoCentryx therapy fails Phase II study in rare renal disorder  ChemoCentryx Inc. (NASDAQ:CCXI) and partner Vifor Fresenius Medical Care Renal Pharma said CCX140 failed to meaningfully reduce proteinuria vs. control in a Phase II study...
BioCentury | May 13, 2020
Regulation

Refusal-to-file letter for BMS-bluebird cell therapy further muddies chances of Celgene payout

Partners BMS and bluebird are insistent that FDA’s refusal-to-file letter for their BCMA-targeting cell therapy is merely the result of a documentation issue that isn’t representative of any larger problem. But the resulting delay, which...
BioCentury | May 6, 2020
Regulation

Extended review of Bristol’s CAR T leaves little daylight for CVR from Celgene deal

The latest delay in the regulatory timeline for BMS’s CAR T therapy liso-cel means that any further snags would jeopardize a potential payout worth up to $6.8 billion to Celgene’s shareholders that was associated with...
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