After shuttering its Lincoln, Neb., OTC facility, the firm recalls some lots of Bufferin, Excedrin, Gas-X and NoDoz. FDA found a “pattern of problems” when inspecting the plant in 2011, and Novartis’ actions suggest it seeks to avoid the same scrutiny that Johnson & Johnson’s OTC recalls elicited.
Novartis Consumer Health Inc. voluntarily recalled some lots of Excedrin pain reliever and other OTC products in hopes of minimizing the damage from quality control failures at its Lincoln, Neb., production facility.
How widespread or costly these issues will prove for the Novartis AG business is unclear. But the Swiss firm...
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
The Canadian regulator says its current policy on identifying and labeling drug products in “kits” is insufficient to address the diverse types of co-packaged drug products that are entering the market.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
