21:21 , Jun 14, 2019 |  BioCentury  |  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...
23:58 , Jun 5, 2019 |  BC Extra  |  Company News

Management tracks: Settleman to lead Pfizer cancer R&D; plus Roivant, LabCorp and more

Pfizer Inc. (NYSE:PFE) hired Jeff Settleman as SVP and group head of oncology R&D, effective July 1. He was head of oncology research at Calico Life Sciences LLC (South San Francisco, Calif.) and prior to...
00:21 , Jun 1, 2019 |  BioCentury  |  Product Development

SMA drug Zolgensma’s label more surprising than its price

FDA surprised Novartis, patient advocates and physicians by approving a label for the pharma’s gene therapy that creates hope that newborns diagnosed with spinal muscular atrophy can be treated before symptoms appear -- in time...
00:05 , May 29, 2019 |  BC Extra  |  Clinical News

Longevity of hemophilia gene therapy in question as BioMarin seeks accelerated approval

As BioMarin reported interim Phase III data Tuesday that sets the company up for regulatory submissions, long-term Phase I/II data cast doubt on the durability of gene therapy valoctocogene roxaparvovec to treat severe hemophilia A....
22:33 , May 24, 2019 |  BC Extra  |  Company News

Novartis breast cancer drug marks first approval of PI3Kα inhibitor

Piqray alpelisib became the first FDA-approved PI3Kα inhibitor on Friday, as well as the first novel drug approved under the agency's Real-Time Oncology Review pilot program. FDA approved the breast cancer drug about three months...
21:09 , May 24, 2019 |  BC Extra  |  Company News

AveXis says label makes Zolgensma gene therapy ‘treatment of choice’ for newly diagnosed SMA

Gene therapy Zolgensma from Novartis’ AveXis unit received a label from FDA that will allow it to become the “treatment of choice” for newly diagnosed spinal muscular atrophy patients, according to the company, as well...
23:55 , May 7, 2019 |  BC Extra  |  Clinical News

More SMA data at AAN suggest new therapies could displace Spinraza

Novartis continued to add on new data for its spinal muscular atrophy gene therapy Zolgensma at AAN while Roche and Genentech presented updated SMA data for their oral small molecule risdiplam. The dosing and potential...
22:05 , May 6, 2019 |  BC Extra  |  Clinical News

Zolgensma data show rapid onset of response for SMA type 2

As Novartis awaits an FDA decision any day on its spinal muscular atrophy gene therapy Zolgensma, data presented over the weekend at AAN suggest that at least half of patients could see a benefit within...
22:17 , Apr 24, 2019 |  BC Extra  |  Company News

Novartis reports details on Zolgensma patient death, hires Saynor as Sandoz CEO

After reporting Phase III efficacy data a week ago for SMA therapy Zolgensma, Novartis unveiled details on a patient death suggesting that it may be linked to previous baseline respiratory complications. The pharma also said...
21:13 , Apr 17, 2019 |  BC Extra  |  Clinical News

Ionis slides after AveXis reports SMA data for Zolgensma

Ionis lost $10.61 (13%) to $72.67 on Wednesday after AveXis reported that Zolgensma improved event-free survival, motor function and milestone achievement in the Phase III STR1VE trial to treat the type 1 form of spinal...