European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. billion in 2022, a product that was launched in 2002. The Soliris (eculizumab) biosimilar is indicated as a treatment for patients with the rare haematology disorder paroxysmal nocturnal haemoglobinuria (PNH).

Marketing 83

Marketing Food and Drug Administration Food Medicine 83

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. The drug is currently under review in Australia, the EU and Switzerland.

FDA 97

FDA Food and Drug Administration Food Pharmaceutical 97

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals. N) = number of approvals.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 89

Manufacturing Pharma Food and Drug Administration Safety 89

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Food and Drug Administration 95

Food and Drug Administration Medicine Safety Consulting 95

World of DTC Marketing

MARCH 17, 2022

What treatment works in one patient may not work in another but we have to keep trying to beat cancer anyway we can. The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. ” There is also the issue of medical debt of surviving cancer patients.

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Food and Drug Administration Medical Ethics Patients 255