Indian company can now make Spinal Muscular Atrophy drug, High Court cites public interest
The high court noted that SMA is a debilitating disease which has no cure, and the only approved drug, Risdiplam, marketed ...
ScienceAlert on MSN1mon
Fetus Receives Life-Saving Medication Inside Womb in Medical First
For this single case, the FDA approved the early administration of the oral drug risdiplam, brand name Evrysdi, owned by the ...
pharmaphorum5d
FDA cues up May verdict for Roche’s SMA challenger risdiplam
The FDA has started a priority review of Roche’s spinal muscular atrophy (SMA) candidate risdiplam, with a decision due by 24 May next year. If approved, risdiplam will be the third drug to be ...
HC allows Natco Pharma to make Swiss firm Roche’s spinal muscular atrophy drug in public interest
The bench said that public good outweighs the company’s profit as the drug is not available at an affordable price in India.
Delhi HC restrains Natco Pharma from launching generic of Roche's rare disease drug
"Roche has filed an appeal against the Hon. Delhi High Court order and the matter is subjudice in the appeal court," Roche ...
Delhi HC tells Natco Pharma to pause launch of generic version of Risdiplam
Roche had appealed against a single judge order of March 24 that had refused to stop Natco Pharma from manufacturing a generic version of Risdiplam ...
The Week7d
How Delhi High Court's latest verdict is a boon for spinal muscular atrophy patients
A rare genetic condition, Spinal Muscular Atrophy (SMA) affects one in 7,000 people in India. It mostly affects children and ...
pharmaphorum9d
Novartis pulls rival to Roche’s risdiplam in SMA, says market limited
While Roche’s oral risdiplam has been tipped by some analysts to be a big contender in the market for spinal muscular atrophy (SMA) treatments, Novartis’ research chief Jay Bradner has a ...
Delhi HC denies interim injunction on Roche rare disease drug, opening the door for generic versions
Patients with Spinal Muscular Atrophy (SMA) are hopeful of getting access to generic versions of Roche’s patented drug ...
Delhi HC rejects Roche's plea to block Natco Pharma on Risdiplam patent
The Delhi High Court denied Roche's request to temporarily restrain Natco Pharma from producing its spinal muscular atrophy ...
Business Wire1mon
FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
About Evrysdi ® (risdiplam) Evrysdi is a survival motor neuron 2 (SMN2) pre-mRNA splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival of motor neuron ...
Medical Dialogues8d
Setback to Roche: Plea Against Natco on Risdiplam Patent Rejected by Delhi HC
In a major relief to Indian drugmaker Natco Pharma, the Delhi High Court has rejected an interim injunction plea filed by ...