Acetaminophen

Savara reports Q3 2024 financials, plans BLA rolling submission for MOLBREEVI in aPAP by end of 2024, updates BLA completion to 1Q 2025, and expects MAA submission to EMA by end of 2025. The company has $219M in cash, sufficient through 2Q 2027.

A Phase 1 study (NCT03733717) administered Isa to adult RRMM patients via IV infusion, starting at 20 mg/kg QW in cycle 1, then Q2W. The regimen was based on globally recommended doses from previous studies. Premedications were given to reduce infusion reactions. The primary objective was to characterize Isa's PK profile in Chinese patients, with secondary objectives including safety, tolerability, immunogenicity, and anti-myeloma activity. Eligible patients had measurable MM, received at least 2 prior lines of treatment, and were refractory to the most recent therapy. Safety and efficacy were assessed using NCI-CTCAE and IMWG criteria, respectively. Statistical analyses were conducted using SAS 9.4 and Phoenix WinNonlin® v8.2.

The FDA proposes removing oral phenylephrine from decongestants due to its ineffectiveness, impacting $1.76 billion market. Popular products like Advil Sinus, Sudafed PE, Vicks DayQuil, and Tylenol Cold & Flu may be affected. Phenylephrine, once deemed effective in 1976, was criticized for lack of efficacy in 2005 and 2007, leading to ongoing debate. The FDA's decision follows recent trials confirming its ineffectiveness at any dose.

The article explains the differences between brand-name and generic drugs, detailing the FDA approval process and how these medications impact patient treatment options. Brand-name drugs are original medications protected by patents, while generics, once the patent expires, must prove equivalency to the original. The main differences lie in cost, appearance, and sometimes formulation, with generics often preferred for cost-effectiveness.

The FDA proposes removing oral phenylephrine, a decongestant in many OTC cold and flu meds, due to concerns over its effectiveness. Phenylephrine, used since 1976, replaced pseudoephedrine in 2006. Studies show no difference between phenylephrine and placebos for congestion relief. CVS removed oral phenylephrine products in 2023. The FDA notes phenylephrine is more effective when applied directly to the nose.

FDA proposes to ban oral phenylephrine from OTC drugs due to ineffectiveness in treating nasal congestion, despite its common use in cold medications. Public comment period open until May 7, 2025, with no safety concerns cited. Proposal does not affect nasal spray form. Alternatives include nasal sprays, oral pseudoephedrine, and antihistamine nasal sprays.

FDA approves Journey Medical’s Emrosi (minocycline hydrochloride extended-release capsules) for rosacea treatment, with initial supplies expected in Q1-Q2 2024. FDA also proposes removing oral phenylephrine from OTC nasal decongestants due to lack of efficacy, and mandates mail-back envelopes for opioid disposal under OA REMS program starting March 2025.

FDA seeks to ban oral phenylephrine in OTC nasal decongestants due to ineffectiveness; no safety concerns; found in NyQuil, Benadryl, Sudafed, Mucinex; public comment period open.

The DEA's proposed rescheduling of cannabis from Schedule I to Schedule III under the Controlled Substances Act, driven by the Biden administration, aims to facilitate medical research and regulatory compliance, though it does not federally legalize marijuana. This shift raises questions about workplace drug policies, particularly in healthcare and transportation sectors, and introduces potential ADA claims if marijuana is no longer federally illegal. The process of rescheduling is lengthy, involving public hearings and extensive review, and may not harmonize with existing state laws, complicating employer compliance.

FDA proposes ban on phenylephrine, deemed ineffective for nasal congestion, despite its inclusion in products like Sudafed PE and Vicks Sinex. The proposal follows an advisory panel's unanimous decision in 2023. The FDA found no evidence supporting phenylephrine's efficacy, and higher doses pose safety risks. The ban would apply to oral forms, not nasal sprays, and is open for public comment until May 7, 2024.