AGL 40.00 No Change ▼ 0.00 (0%)
AIRLINK 128.01 Decreased By ▼ -1.52 (-1.17%)
BOP 6.71 Increased By ▲ 0.03 (0.45%)
CNERGY 4.45 Decreased By ▼ -0.18 (-3.89%)
DCL 8.62 Decreased By ▼ -0.32 (-3.58%)
DFML 40.50 Decreased By ▼ -1.19 (-2.85%)
DGKC 80.00 Decreased By ▼ -3.77 (-4.5%)
FCCL 32.73 Decreased By ▼ -0.04 (-0.12%)
FFBL 74.30 Decreased By ▼ -1.17 (-1.55%)
FFL 11.50 Increased By ▲ 0.03 (0.26%)
HUBC 109.20 Decreased By ▼ -1.35 (-1.22%)
HUMNL 13.80 Decreased By ▼ -0.76 (-5.22%)
KEL 5.34 Decreased By ▼ -0.05 (-0.93%)
KOSM 7.90 Decreased By ▼ -0.50 (-5.95%)
MLCF 38.60 Decreased By ▼ -1.19 (-2.99%)
NBP 62.70 Increased By ▲ 2.41 (4%)
OGDC 195.00 Decreased By ▼ -4.66 (-2.33%)
PAEL 25.71 Decreased By ▼ -0.94 (-3.53%)
PIBTL 7.36 Decreased By ▼ -0.30 (-3.92%)
PPL 155.50 Decreased By ▼ -2.42 (-1.53%)
PRL 25.65 Decreased By ▼ -1.08 (-4.04%)
PTC 17.13 Decreased By ▼ -1.33 (-7.2%)
SEARL 78.00 Decreased By ▼ -4.44 (-5.39%)
TELE 7.80 Decreased By ▼ -0.51 (-6.14%)
TOMCL 33.20 Decreased By ▼ -1.31 (-3.8%)
TPLP 8.35 Decreased By ▼ -0.71 (-7.84%)
TREET 16.51 Decreased By ▼ -0.96 (-5.5%)
TRG 57.50 Decreased By ▼ -3.82 (-6.23%)
UNITY 27.50 Increased By ▲ 0.07 (0.26%)
WTL 1.42 Increased By ▲ 0.04 (2.9%)
BR100 10,497 Increased By 90.3 (0.87%)
BR30 31,350 Decreased By -362.9 (-1.14%)
KSE100 97,549 Increased By 220.5 (0.23%)
KSE30 30,374 Increased By 181.4 (0.6%)

Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving $2.1 million gene therapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data integrity. Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the US Food and Drug Administration before it won approval for the world's most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal investigation.
While the FDA has concluded Zolgensma is safe and effective and should remain on the market, the US drug watchdog raised questions about the timing of Novartis's disclosure. US senators have also demanded the Swiss drugmaker explain why it took so long to inform the agency. Novartis could face possible civil or criminal penalties, the FDA has said. Zolgensma treats spinal muscular atrophy, the leading genetic cause of death in infants.
"We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality (control) organisation of any credible allegation related to data integrity impacting any pending application in the Novartis Group," Narasimhan said at an investor event, adding Novartis will take a similar approach in other jurisdictions.
Novartis said it gave "detailed explanations" on Aug. 23 to the FDA about the company's investigation into the data manipulation, and addressed regulators' questions over why the company waited until late June to make disclosures. The company has said it has "exited" scientists it identified in its data manipulation probe. One of those scientists, Brian Kaspar, through his lawyer, has denied wrongdoing.

Copyright Reuters, 2019

Comments

Comments are closed.