European Pharmaceutical Review

JULY 11, 2023

A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted the importance of post-approval R&D in advancing oncology treatment options and delivering unprecedented progress over the past ten years.

Food and Drug Administration 74

Food and Drug Administration Medicine Pharmaceutical research FDA 74

Pharmaceutical Technology

SEPTEMBER 15, 2022

However, the FDA's approval of Lumakras for metastatic non-small cell lung cancer in May last year has a global analyst consensus sales forecast of $336m for this year, according to GlobalData’s Drugs Database. BMS expects to see a YoY decrease in its sales of Revlimid from this year onwards. Amgen reported only a marginal 2.2%

Sales 108

Sales Competition Pharmaceutical Pharmaceutical research 108

Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

FDA 145

FDA Pharmaceutical Prospecting Medicine 145

Pharmaceutical Technology

DECEMBER 21, 2022

In pharmaceutical research, this may help secure the privacy of patient data used by AI systems and decrease bias due to ethnicity, sex and other factors. FDA and EMA action.

Pharma 140

Pharma Pharmaceutical Medicine Government 140

Pharmaceutical Technology

MAY 17, 2023

However, Randy Burkholder, vice president of policy and research for the industry group Pharmaceutical Research and Manufacturers of America (PhRMA), said this provision amounted to government “price setting” that would harm future research and development efforts.

Food and Drug Administration 52

Food and Drug Administration Pharma Patients Pharmaceutical research 52

Pharmaceutical Technology

APRIL 12, 2023

Pharmaceutical research has long relied on non-human primate models for early-stage discoveries, but their use continues to cause controversy. Globally, non-human primates make up a relatively small percentage of the animals used in research. The ABPI points to the FDA in the US as an example.

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97