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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Pharmacopoeia guidance on DEG and EG. Ann Intern Med.

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Competition is on the horizon for costly narcolepsy treatments

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Tentative approval means Lumryz has satisfied all the FDA requirements for efficacy, safety, and quality standards, but it can’t be fully approved until a patent or other exclusivity expires. Furthermore, Molina stated Jazz “suppressed generic competition and raised the price of Xyrem 841% between 2007 and 2014.”

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Continuous manufacturing: an evolving technology for drug substance manufacturing

European Pharmaceutical Review

For pharmaceuticals, the motivating factors likely include the desire for greater quality control, along with expected improvements in safety and efficiency. 1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere.

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Company profile: NeoImmuneTech

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NT-I7 exhibits reliable Pharmacokinetic (PK) and safety profiles, making it an ideal combination partner. Across the current 14 on-going clinical trials, safety results have been very consistent: NT-I7 has demonstrated a well-tolerated safety profile. Several combinations being studied. He received his Ph.D.

Safety 105
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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

2007; 2(1):5-11. neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. 2022 ; 17(11). Fitzcharles-Bowe C et al. Hand (N Y). Derived from IQVIA Claims Data, 2023.

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

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It is, however, the first that can be substituted across all Lucentis’ five indications and to be fully interchangeable – which means it is considered to have no clinically meaningful difference compared to the reference drug in safety, purity, or potency and can be substituted for it without any prescriber intervention.

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NK cell immunotherapy: what’s next in clinical development?

European Pharmaceutical Review

A favorable safety profile was also observed. Beyond Sezary Syndrome, lacutamab showed also preliminary safety and efficacy in TELLOMAK on the first 21 patients having KIR3DL2-expressing Mycosis fungoides with an encouraging global response rate of 28.6 An ORR of 46.4 percent has been also reported in the skin and 48.2

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