BioCentury | Mar 3, 2020
Product Development

March 2 Quick Takes: FDA Priority Review for MorphoSys-Incyte lymphoma therapy; plus Pfizer-Lilly, Merck, AbbVie, Novartis, Cerovene

Priority Review for MorphoSys follows Incyte deal  FDA accepted and granted Priority Review to a BLA for tafasitamab from MorphoSys AG (NASDAQ:MOR; Xetra:MOR) to treat relapsed or refractory diffuse large B cell lymphoma in combination...
BioCentury | Feb 26, 2020
Product Development

Feb. 25 Quick Takes: Vanda’s Phase III miss; plus Iovance; 1st-twoXAR; app for AFib, stroke; ICER-Aetion; new-look Purple Book, and more

Vanda’s itch therapy misses in atopic dermatitis   Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares tumbled after market close Tuesday after tradipitant missed the primary endpoint in the Phase III EPIONE trial to treat atopic dermatitis in...
BioCentury | Feb 18, 2020
Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat...
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 | Oct 8, 2019
Company News

Oct. 8 Company Quick Takes: Novartis’ anti-VEGF approved for AMD; plus Merck-4D, Acorda, Clinuvel and Puma

Novartis’ Eylea competitor approved  FDA approved Beovu brolucizumab-dbll from Novartis AG (NYSE:NVS; SIX:NOVN) to treat wet age-related macular degeneration. In the Phase III HAWK and HARRIER trials, the anti-VEGF single-chain antibody fragment led to vision...
BioCentury | Oct 5, 2019
Finance

Seeking bright spots in 4Q19 amid continued underperformance

Biotech watchers are hoping a busy fourth quarter of data readouts, regulatory actions and IPOs will provide some bright spots to counteract the sector’s continued overall underperformance, which is not expected to improve in 2020....
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 | Jun 14, 2019
Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
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...
BioCentury | Apr 6, 2019
Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
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