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 81

Side effects Safety Biopharma Recruitment 81

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

Side effects 102

Side effects Biopharma Patients Competition 102

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

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

Medicine 52

Medicine Biopharma Safety Food 52

Clarivate

OCTOBER 25, 2023

The biggest impacts are likely to be felt by patients with PDPs that use coinsurance, which most plans do for specialty drugs. Impact for patients taking the diabetes drugs and blood thinners might be less noticeable since these drugs tend to receive coverage as preferred brand tiers with copays.

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Positive outcomes in a key patient segment could broaden TRODELVY’s uptake in metastatic breast cancer. Market impact.

Marketing 52

Marketing Safety Patients 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