JD Supra1h
Investigations Newsletter: Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed ...
FiercePharma4d
After delay with FDA, Novartis touts pivotal trial win for intrathecal Zolgensma in older SMA patients
More than three years after Novartis’ plan for a speedy approval for intrathecal Zolgensma was thwarted by an FDA requirement ...
Novartis Says New Drug Helps Children With Rare Spinal Condition
Novartis AG said a new experimental medicine improved motor function in children with a form of spinal muscular atrophy, the ...
Novartis must face claims it paid kickbacks to promote MS drug, US appeals court rules
A U.S. appeals court on Friday revived a whistleblower lawsuit accusing Swiss drugmaker Novartis of paying illegal kickbacks ...
Novartis gene therapy helps children with rare muscle disorder in study
Swiss drugmaker Novartis said on Monday its gene therapy helped improve motor function in children with a rare muscle ...
Pharmaceutical Technology23h
Iptacopan hydrochloride by Novartis for Proteinuria: Likelihood of Approval
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, ...
Pharmaceutical Technology22h
ITU-512 by Novartis for Sickle Cell Disease: Likelihood of Approval
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, ...
SA Asks: Which biotechs are most likely to be acquired near-term?
Which biotechs are most likely to be acquired near-term? We asked Seeking Alpha analysts Edmund Ingham and Terry Chrisomalis for their thoughts on the topic. Read more here.
pharmaphorum6d
New data could widen use of Novartis' SMA therapy Zolgensma
Now, Novartis hopes to be able to share the data with regulatory authorities in 2025, including the US FDA, in the hope of ...
Positive data could expand use of Novartis’ gene therapy for SMA
On 30 December 2024, Novartis reported that its intrathecal (IT) formulation of onasemnogene abeparvovec (OAV101 IT) reached ...
Novartis’ Phase III spinal muscular atrophy therapy trial meets primary endpoint
Novartis has reported positive topline outcomes from the Phase III STEER trial of an investigational gene therapy, ...
Novartis7d
Novartis intrathecal onasemnogene abeparvovec Phase III study meets primary endpoint in children and young adults with SMA
The Phase III STEER study met its primary endpoint showing an increase from baseline in HFMSE total score in patients with SMA treated with intrathecal onasemnogene abeparvovec (OAV101 IT) OAV101 IT ...