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. FDA continues to approve the most NASs. 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 84

Manufacturing Pharma Food and Drug Administration Safety 84

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. But it’s’ still the leading cause of cancer deaths.

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255

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 90

Food and Drug Administration Medicine Safety Consulting 90

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 percent and 14.3

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Evolve Your Success

FEBRUARY 7, 2023

The patients like that their copay is lower. Patients have a lower copay. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world. It was April 23, 2002. Do you want to go into healthcare administration? I want to get into pharma.”

Medical 52

Medical Sales Medical sales Doctors 52