BC Extra | Dec 13, 2019
Company News

Novartis gains CHMP support for Eylea competitor in wet AMD

EMA's CHMP issued a positive opinion for Novartis’ Beovu brolucizumab in its December roundup of opinions, none of which were negative. The agency backed an MAA from Novartis AG (NYSE:NVS; SIX:NOVN) for Beovu to treat...
BC Extra | Aug 20, 2019
Clinical News

Aug. 20 Clinical Quick Takes: Oxurion misses in Phase II macular edema study; plus NuCana and Moleculin

Oxurion misses in macular edema trial  Oxurion N.V. (Euronext:OXUR) sank €2.39 (43%) to €3.18 after reporting that THR-317 plus Lucentis ranibizumab did not improve mean Best Corrected Visual Acuity (BCVA) at three months, the primary...
BC Innovations | Jun 27, 2019
Product Development

Gene therapy’s next frontier lies beyond rare, monogenic diseases

As in vivo gene therapies continue notching approvals for rare monogenic diseases, the next frontier for the modality will be in treating complex indications without obvious genetic drivers. At least seven companies have clinical or...
BioCentury | May 11, 2019
Product Development

Now grown up, independent biotechs bulk up their platforms with more modalities

As the incoming class of independent biotechs look to build on their clinical and commercial successes, a handful are expanding beyond the technology that got them there, bringing in new modalities to complement their platforms...
BC Extra | Apr 15, 2019
Company News

FDA accepts BLA for Novartis' AMD therapy

Novartis said FDA accepted for review a BLA for brolucizumab to treat wet age-related macular degeneration. The pharma said it used a Priority Review voucher for the application, but declined to disclose details about the...
BC Week In Review | Nov 9, 2018
Clinical News

Adverum reviewing capsid after discontinuing AAT gene therapy

Adverum Biotechnologies Inc. (NASDAQ:ADVM) will discontinue development of gene therapy ADVM-043 to treat α-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency. The company said that although ADVM-043 was well tolerated among six patients in the open-label, U.S....
BC Week In Review | Nov 2, 2018
Clinical News

Genentech's faricimab improves BCVA in Phase II for wet AMD

Genentech Inc. reported data from the Phase II STAIRWAY trial to treat wet age-related macular degeneration (AMD) showing that faricimab (RG7716) dosed every 12 or 16 weeks led to sustained improvements in visual outcomes that...
BC Week In Review | Nov 2, 2018
Clinical News

Eylea meets 52-week endpoint in Phase III for diabetic retinopathy subset

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said both dosing schedules of Eylea aflibercept met the 52-week primary endpoint in the Phase III PANORAMA trial for early intervention of non-proliferative diabetic retinopathy without diabetic macular edema (DME). The...
BC Extra | Nov 2, 2018
Clinical News

Adverum reviewing capsid after discontinuing AAT gene therapy

Adverum Biotechnologies Inc. (NASDAQ:ADVM) sank $1.21 (27%) to $3.34 on Friday after it said it will discontinue development of gene therapy ADVM-043 to treat α-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency. The company said late Thursday...
BC Week In Review | Oct 5, 2018
Company News

U.K. judge upholds preferred prescribing of Avastin off label for wet AMD

A U.K. judge upheld in September a policy of prescribing Avastin bevacizumab as the preferred treatment option for wet age-related macular degeneration (AMD) over Eylea aflibercept and Lucentis ranibizumab. Avastin does not have marketing authorization...
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