Archive for December 2021
FDA Investigators See Shortcomings at Novartis Gene Therapies Facility
Novartis Gene Therapies’ Libertyville, Ill., plant, which produces Zolgensma — the world’s most expensive drug at more than $2.1 million per treatment — has drawn a Form 483 with five observations during a June 8-16 inspection by the FDA. Source: Drug Industry Daily
Read MoreXeris Wins FDA Approval of Recorlev for Cushing’s Syndrome
The FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) for treating hypercortisolemia in adults with Cushing’s syndrome who are unable to undergo surgery. Source: Drug Industry Daily
Read MoreWithout mRNA Booster, CoronaVac Is Useless Against Omicron
CoronaVac, Sinovac’s COVID-19 vaccine, appears to be completely ineffective against the Omicron variant unless boosted with an mRNA vaccine, new data suggest. Source: Drug Industry Daily
Read MorePandemic-Era Strategy Has Limitations for Future Drug Development, Survey Finds
The approach taken by drugmakers during the pandemic turned out COVID-19 vaccines in record time, but it has some shortcomings for use in future drug development and manufacturing, according to a survey of more than 500 industry leaders. Source: Drug Industry Daily
Read MoreFDA Set to Authorize Pfizer COVID-19 Booster Shot in Adolescents
The FDA is poised to authorize a third booster dose of the Pfizer-BioNTech COVID-19 vaccine for use in adolescents aged 12 to 15. Source: Drug Industry Daily
Read MoreSanofi’s Push to Reinstate Lantus Patents Blocked by Federal Court
A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Source: Drug Industry Daily
Read MoreJury Finds Teva Liable in New York’s Opioid Trial
A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Source: Drug Industry Daily
Read MoreBridgeBio’s Potential Cardiomyopathy Treatment Can’t Cross the Phase 3 Finish Line
BridgeBio’s investigational cardiomyopathy molecule acoramidis (AG10) fell short of the phase 3 finish line this week, when it not only failed its primary endpoint, but was associated with decreases in a functional measure of cardiac fitness relative to placebo. Source: Drug Industry Daily
Read MoreJ&J’s Booster Offers Strong Protection Against Hospitalization
Two doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Ad26.COV2.S) cut the risk of a COVID-related hospitalization by 85 percent, the company has reported — and the benefit may be coming from ramped-up T-cells rather than vaccine-induced antibodies. Source: Drug Industry Daily
Read MoreFederal Court Orders New Jersey Foundation to Stop Distributing Misbranded Drug for COVID-19
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy all product distributed this year. Source: Drug Industry Daily
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