Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

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Regulations Clinical Trials Production International 40

Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. So if you're a researcher, you can pour your heart and soul into a hepatitis C vaccine, and it probably won't ever get tested.

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Vaccine Trials Disease Virus 117

Drug Discovery World

MARCH 13, 2023

They can manufacture the drug substance and then pass it to a specialised fill-finish facility that will load it into its final sterile packaging.   Conversely, cell therapy manufacturing starts with a highly heterogeneous source material: human blood. McKinsey &Company Pharmaceuticals & Medical Products Practice.

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Therapies Drug Development Clinical Trials Cell Based Assays 130

Agency IQ

NOVEMBER 27, 2023

In recent years, nitrosamines, and most commonly N-nitrosodimethylamine (NDMA), have been found in finished drug products in several classes, including medicines used for diabetes, hypertension, acid reflux, and smoking cessation. [ In a study of more than 12,000 small molecule drugs , researchers found 40.4%

Regulations 40

Regulations Production FDA Packaging 40

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The average annual growth in non-orphan pharmaceutical expenditure in the same period was only 3%. member states.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

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FDA Science Production Regulations 40