article thumbnail

Are timely access and robust safety mutually exclusive?

pharmaphorum

And how can regulators balance timely access with robust safety? A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. The post Are timely access and robust safety mutually exclusive?

Safety 96
article thumbnail

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Safety 113
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

The trial’s data readout found that the momelotinib group had a favourable safety profile and the drug caused clinically significant improvements in myelofibrosis-associated symptoms, anaemia symptoms, and more, in comparison to the danazol group.

article thumbnail

Thursday pharma headlines

World of DTC Marketing

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma 180
article thumbnail

Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. 2011 Dec;12(4):1248-63. Eur Pharm Rev.

article thumbnail

Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

FDA 98
article thumbnail

Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson. MSCs and CAR-Ts for lupus.