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Stakeholders Urge Faster Generic Approval, Save Healthcare Dollars
Earlier this week, the FDA heard from various stakeholders and experts from the healthcare industry on how delays in the generic approval process impact healthcare costs.
Earlier this week, the FDA heard from various stakeholders and experts from the healthcare industry on how delays in the generic approval process impact healthcare costs. The meeting saw participation by members of the Generics Pharmaceutical Association, Specialty Pharma Association, Bulk Pharmaceutical Task Force, and Kaiser Permanente's Medical Group.
Participants urged the FDA to reduce the generic drug review period (currently at about 50 months), which they say could have saved the healthcare system over $3 billion over a year and a half. These delays reduce access for patients who then have to turn to more expensive brand-name drugs.
Generic Drug User Fee Amendments (GDUFA) fee schedule; smaller companies or biotechs that file for an abbreviated new drug application have to pay the same GDUFA fees as big pharma, which
Perry Cole, president and executive director of Specialty Pharma Association, thinks “Is financially unfair to smaller companies.”
Another point raised during the meeting was the similar
Read more at Insider Health Policy: http://bit.ly/1JZKnBF
NK Cell Therapy SNK01 Improves Cognitive Function in Alzheimer Disease for up to 11 Weeks
December 3rd 2023Among 10 patients evaluated, compared with their baseline at 1 week after receiving their final dose in the trial, 30% demonstrated clinical improvement on the Alzheimer’s disease composite score.
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Consumers should not eat precut cantaloupe if they do not know the source, as the number of illnesses and recalls tied to a deadly salmonella outbreak grows; the White House and the Department of Education urged schools to take proactive steps to prevent youth drug use; a study published this week found a high prevalence of arrhythmia in patients with long COVID.
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Understanding the Unmet Need for Therapies to Treat Rare Bile Duct Cancer
May 24th 2022On this episode of Managed Care Cast, we bring you an excerpt of an interview with a co-chair of the 2022 Cholangiocarcinoma Foundation (CCF) annual conference, held earlier this year, about the significant unmet therapy needs facing most patients with this rare cancer.
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Bimekizumab-bkzx, the Newest Psoriasis Treatment, Is Now Available
November 30th 2023Bimekizumab-bkzx (Bimzelx) is the first dual interleukin 17A (IL-17A) and interleukin 17F (IL-17F) inhibitor to treat moderate-to-severe plaque psoriasis. It launches with a list price of $7200 per syringe.
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