pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

Side effects 84

Side effects Safety Biopharma Recruitment 84

Clarivate

OCTOBER 25, 2021

This year, Clarivate acquired Bioinfogate , a leading provider of analytics solutions in the life sciences and producer of the OFF-X portal. The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle.

Safety 110

Safety Biopharma Competition Management 110

PM360

DECEMBER 20, 2023

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. This allows for a complementary portfolio fit without the kind of competitive overlap that comes under regulatory scrutiny from the FTC.

Biopharma 111

Biopharma Pharma Marketing Management 111

European Pharmaceutical Review

DECEMBER 19, 2022

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

Medicine 52

Medicine Biopharma Safety Food 52

Clarivate

JULY 31, 2023

The migration of these products and services into the Clarivate portfolio further bolster solutions that support pharmacovigilance medical literature monitoring, patent research, systematic review literature searches, MDR literature review searches, as well as competitive and business intelligence research.

Healthcare 52

Healthcare Healthcare Safety Competition 52

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

Networking 59

Networking Consulting Safety Side effects 59

Clarivate

OCTOBER 25, 2023

exclusions exist for orphan drug designation and biosimilar competition ). Expect some provider practices to research using alternative treatments not subject to price negotiations for their new patients, assuming comparable efficacy, safety, and tolerability (e.g.,

Prescription 52

Prescription Physicians Manufacturing Healthcare 52