BioCentury | May 22, 2020
Product Development

May 21 Quick Takes: EC approves Zolgensma for SMA; plus Sunovion, Kadmon, Sorrento, tafasitamab, Zentalis’ new JV

Immediate access to Zolgensma in France  The European Commission conditionally approved Zolgensma onasemnogene abeparvovec from Novartis AG (NYSE:NVS; SIX:NOVN) to treat spinal muscular atrophy in babies and young children who have SMA Type 1 or...
BioCentury | Mar 26, 2020
Regulation

China’s NMPA suspends Abraxane imports after U.S. inspection

China’s suspension of the importation and sale of Celgene’s Abraxane by BeiGene following an inspection at a U.S. manufacturing site demonstrates how far the country has come in its drive to ensure safety of drugs,...
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 | Mar 3, 2020
Product Development

Following Phase III readout, Karyopharm seeks approval of Xpovio for second-line MM

Karyopharm gained $11.38 (70%) to $27.72 on Monday, adding about $746 million in market value, after announcing that Xpovio selinexor met the primary endpoint of improving PFS in the confirmatory Phase III BOSTON trial to...
BioCentury | Mar 3, 2020
Regulation

Sanofi sees first fruit of renewed oncology commitment with Sarclisa approval

Sarclisa isatuximab will be the first oncology drug Sanofi launches in more than a decade, its approval Monday marking the pharma’s first cancer win after its re-entry into the space. The company’s next step is...
BC Extra | Jan 13, 2020
Company News

MorphoSys nets $900M up front in global deal with Incyte for anti-CD19 mAb

The first major deal under the watch of MorphoSys’ new CEO Jean-Paul Kress triples the German biotech’s cash position through a global partnership with Incyte to develop and commercialize blood cancer therapy tafasitamab. While the...
BC Extra | Jan 7, 2020
Company News

BeiGene looks to carve out niche in China for tislelizumab

As it looks to roll out what will be at least the sixth marketed PD-1 inhibitor in China, BeiGene hopes the therapy’s differentiated efficacy profile and commercial infrastructure will help the company carve a niche...
BC Innovations | Dec 6, 2019
Targets & Mechanisms

A view of immune reprogramming from ASH

ASH presentations on immune reprogramming point to new targets and mechanisms that control macrophage and T cell phenotype switching, and highlight the phenomenon's translational relevance in diseases beyond solid tumors. Strategies to convert immunosuppressive macrophage...
BioCentury | Nov 9, 2019
Product Development

Amgen to accelerate China strategy via BeiGene deal

Amgen is taking a hybrid approach to building out its China business that will allow it to accelerate its commercial plans in the country without biting off more than it can chew. Through the deal...
BC Innovations | Nov 7, 2019
Targets & Mechanisms

New cereblon substrates linked to thalidomide teratogenicity

A Celgene-funded study from Tokyo Medical University and the University of Milan has identified two new thalidomide-dependent CRBN substrates that could be applied to screens for new, safer thalidomide derivatives. Thalidomide and its analogs, collectively...
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