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Home » Authors » Jennifer Boggs

Articles by Jennifer Boggs

Array boosts data ahead of NDA for BRAF/MEK combo in melanoma

May 11, 2017
By Jennifer Boggs
While last year's positive readout from the first part of Array Biopharma Inc.'s phase III COLUMBUS trial testing binimetinib and encorafenib in BRAF-mutant advanced, unresectable or metastatic melanoma cleared the way for regulatory filings, supplementary results from the study's second part, released late Tuesday, could bolster the combination's prospects for approval and market penetration.
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Mitsubishi Tanabe's ALS drug wins nod ahead of PDUFA date

May 9, 2017
By Jennifer Boggs
The FDA has joined Japanese and South Korean regulators in approving edaravone, an intravenously administered antioxidant free radical scavenger, for treating amyotrophic lateral sclerosis (ALS), with its late Friday approval coming more than a month ahead of the PDUFA date.
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Astrazeneca joins I-O party, gets FDA nod in bladder cancer

May 2, 2017
By Jennifer Boggs
Astrazeneca plc won FDA accelerated approval for durvalumab, its breakthrough-designated PD-L1 inhibitor, for treating locally advanced or metastatic urothelial carcinoma, a market in which it will face Roche Holding AG’s Tecentriq (atezolizumab), approved in May 2016.
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Argos Therapeutics is not ready to bail on ADAPT, seeks benefit in longer-term follow-up

April 20, 2017
By Jennifer Boggs

Companies ignoring the advice of their independent data monitoring committees (IDMCs) do so at their own peril, but Argos Therapeutics Inc. might have a more compelling case than most for opting to continue the phase III ADAPT study testing rocapuldencel-T in combination with Sutent (sunitinib, Pfizer Inc.) in metastatic renal cell carcinoma (mRCC), despite a disappointing interim analysis in February, in which the IDMC recommended the study be stopped for futility.


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Ultragenyx gearing up for BLA after positive phase III XLH study

April 20, 2017
By Jennifer Boggs
Ultragenyx Pharmaceutical Inc. said it believes data from a phase III study testing burosumab (KRN23), a recombinant fully human monoclonal IgG1 antibody, are sufficient to support a BLA filing this year in X-linked hypophosphatemia (XLH), a bone disease characterized by phosphate wasting due to excess activity of FGF23.
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Amorchem spinout Mperia advancing CD36 drug-ligand in dry AMD

April 18, 2017
By Jennifer Boggs
When going after macrophages, "in my view, you play directly with the immune system," said Maxime Ranger, president and CEO of 2016 startup Mperia Therapeutics Inc., which is advancing macrophage-targeting immunotherapies based on the CD36 scavenger receptor for diseases involving chronic inflammation such as dry age-related macular degeneration (AMD) and atherosclerosis.
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Wave Life adding $100M as it preps first three drugs for clinical launch

April 13, 2017
By Jennifer Boggs
Wave Life Sciences Ltd. boasted a balance sheet of $150.3 million as of Dec. 31, funds the company said during its fourth-quarter earnings should get the firm into 2019. But as always in the field of drug development, a little extra padding never hurts, and Cambridge, Mass.-based Wave Life priced a $100 million public offering Wednesday as it gets ready to move its first three candidates into the clinic targeting CNS and neurological disorders.
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Double phase III win for Vertex's two-drug CF combo; filings in 3Q

March 30, 2017
By Jennifer Boggs
Vertex Pharmaceuticals Inc. is targeting third quarter filings in the U.S. and Europe after reporting positive data from two phase III studies testing oral CFTR corrector tezacaftor (VX-661) plus approved CFTR potentiator Kalydeco (ivacaftor) in cystic fibrosis (CF), a combination expected to broaden the swath of patients eligible for therapy.
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As Zejula joins PARP parade, Tesaro is focusing on an expanded clinical plan

March 28, 2017
By Jennifer Boggs
Even as Tesaro Inc. prepares to launch newly approved Zejula (niraparib) late next month in ovarian cancer, the Waltham, Mass.-based company already is setting sights on an expanded clinical development program for the PARP inhibitor, which is not restricted to patients with BRCA mutations.
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Beyond the checkpoint: Pionyr advancing I-O via precision tuning

March 23, 2017
By Jennifer Boggs
The advent of checkpoint inhibitors yielded a big win for the burgeoning immuno-oncology space, supercharging activated T cells to attack cancer cells, and the success with drugs targeting CTLA-4 and PD-1 has translated into efforts chasing other checkpoint mechanisms, all in the hopes of expanding the stunning results into broader patient populations.
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