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 | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BC Extra | Jun 3, 2019
Company News

June 3 Company Quick Takes: EU pharmas form consortium to predict late-stage success; plus Lilly/Atomwise, Gilead/HitGen, Emergent and more

EU public-private consortium aims to better predict late-stage compounds  A group of pharmaceutical, technology and academic institutions formed a consortium to use machine learning on chemical libraries of 10 pharmaceutical companies to develop a platform...
BC Week In Review | Sep 28, 2015
Clinical News

Scenesse afamelanotide regulatory update

Clinuvel said that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to a post-authorization safety study (PASS) protocol, which now allows the company to launch Scenesse afamelanotide to treat erythropoietic protoporphyria (EPP). The PASS protocol...
BC Week In Review | Feb 16, 2015
Clinical News

Scenesse afamelanotide regulatory update

In December, the European Commission approved under exceptional conditions Scenesse afamelanotide from Clinuvel to prevent phototoxicity in patients with erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the...
BC Week In Review | Nov 17, 2014
Company News

Clinuvel, Biotech Lab Singapore deal

Clinuvel and Biotech Lab Singapore formed a JV to develop pediatric formulations of Clinuvel's Scenesse afamelanotide ( CUV1647 ) and CUV9900 . Clinuvel will lead and oversee regulatory development, while Biotech Lab Singapore will manage chemistry and formulation...
BC Week In Review | Oct 27, 2014
Clinical News

Scenesse afamelanotide regulatory update

EMA's CHMP recommended approval of Scenesse afamelanotide from Clinuvel to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Scenesse was the first product to be...
BC Extra | Oct 25, 2014
Company News

CHMP recommends Clinuvel's Scenesse

EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic protoporphyria (EPP), a disorder characterized by extreme sensitivity to sunlight. Scenesse...
BioCentury | Oct 6, 2014
Finance

4Q14 Financial Markets Preview: Commercial race in HCV

HCV and cancer immunotherapy again top the list of milestones in 4Q14, as investors expect approval of three new HCV regimens plus clinical data for combos looking to challenge Gilead Sciences Inc. and AbbVie Inc....
Items per page:
1 - 10 of 96
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 | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BC Extra | Jun 3, 2019
Company News

June 3 Company Quick Takes: EU pharmas form consortium to predict late-stage success; plus Lilly/Atomwise, Gilead/HitGen, Emergent and more

EU public-private consortium aims to better predict late-stage compounds  A group of pharmaceutical, technology and academic institutions formed a consortium to use machine learning on chemical libraries of 10 pharmaceutical companies to develop a platform...
BC Week In Review | Sep 28, 2015
Clinical News

Scenesse afamelanotide regulatory update

Clinuvel said that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to a post-authorization safety study (PASS) protocol, which now allows the company to launch Scenesse afamelanotide to treat erythropoietic protoporphyria (EPP). The PASS protocol...
BC Week In Review | Feb 16, 2015
Clinical News

Scenesse afamelanotide regulatory update

In December, the European Commission approved under exceptional conditions Scenesse afamelanotide from Clinuvel to prevent phototoxicity in patients with erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the...
BC Week In Review | Nov 17, 2014
Company News

Clinuvel, Biotech Lab Singapore deal

Clinuvel and Biotech Lab Singapore formed a JV to develop pediatric formulations of Clinuvel's Scenesse afamelanotide ( CUV1647 ) and CUV9900 . Clinuvel will lead and oversee regulatory development, while Biotech Lab Singapore will manage chemistry and formulation...
BC Week In Review | Oct 27, 2014
Clinical News

Scenesse afamelanotide regulatory update

EMA's CHMP recommended approval of Scenesse afamelanotide from Clinuvel to treat erythropoietic protoporphyria (EPP), a severe genetic disorder causing absolute ultraviolet radiation and light intolerance in the skin. Scenesse was the first product to be...
BC Extra | Oct 25, 2014
Company News

CHMP recommends Clinuvel's Scenesse

EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic protoporphyria (EPP), a disorder characterized by extreme sensitivity to sunlight. Scenesse...
BioCentury | Oct 6, 2014
Finance

4Q14 Financial Markets Preview: Commercial race in HCV

HCV and cancer immunotherapy again top the list of milestones in 4Q14, as investors expect approval of three new HCV regimens plus clinical data for combos looking to challenge Gilead Sciences Inc. and AbbVie Inc....
Items per page:
1 - 10 of 96