European Pharmaceutical Review

JUNE 28, 2022

billion by 2026, achieving a compound annual growth rate (CAGR) of 13.2 percent CAGR between 2022 and 2026. According to recent market research , the global market for biopharmaceutical bioseparation systems, estimated to value $13 billion in 2022, is projected to grow to $19.6

Dosage 111

Dosage Compounding Drug Development 111

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Dosage Packaging Labelling 96

European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Blister packs can also benefit from anticounterfeiting holography.

Packaging 111

Packaging Labelling Documentation Dosage 111

FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

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Dosage Drug Pricing 64

European Pharmaceutical Review

SEPTEMBER 26, 2023

Tyruko ® has the same strength/dosage form, intravenous (IV) route of administration, dosing regimen and presentation as the reference medicine, according to Sandoz. The site is planned to be completed by 2026. Tysabri ® is a registered trademark of Biogen MA, Inc.

Biosimilars 59

Biosimilars Dosage Packaging 59

European Pharmaceutical Review

MARCH 9, 2023

With a career spanning over 20 years, Dr Hotha has extensive expertise in developing drug substances and products, particularly in HPAPI, Drug linkers, ADCs, and complex drug dosage forms. He has authored over 40 scientific research publications and serves on several editorial boards. internet] GlobeNewswire. Research and Markets.

Compounding 98

Compounding Dosage Communication 98

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

Dosage 59

Dosage 59