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Wholesale price increases for brand-name drugs analyzed by the research group 46Brooklyn outpaced inflation for the past two years with a median increase of 5 percent in both years. Read More
Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. When pediatric trials must be conducted first, sponsors should provide a rationale for why adult studies are not ethical or feasible, the guidance says. Read More
Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More
HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More
The Department of Justice quotes extensively from internal Walmart documents allegedly showing its pharmacists raised “red flags” against illicit opioid prescribers but that the company filled the prescriptions anyway, in a federal civil lawsuit filed against the company. Read More
The pharmaceutical industry will see more mergers and acquisitions in 2021 than in the pandemic-depressed year just ended, top financial firms are saying. Read More
The FDA has released a draft guidance on investigational new drug (IND) submissions by developers of individualized gene therapies that use antisense oligonucleotides (ASO), as part of the agency’s ongoing efforts to encourage orphan drugs. Read More