pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA 89

FDA Side effects Biopharma Marketing 89

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 85

Side effects Safety Biopharma Recruitment 85

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 59

Consulting Side effects Manufacturing Safety 59

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). For example, in the U.S.,

Networking 59

Networking Consulting Safety Side effects 59

European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. Can you share an update on the clinical trial for your lead candidate? Hoppin served as lead director of Noria as the two organisations were sold to Bayer Healthcare in June of 2021.

Food and Drug Administration 89

Food and Drug Administration Side effects Manufacturing Doctors 89

PM360

JULY 13, 2023

Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC). The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023.

Patients 98

Patients Engineering Side effects Leads 98

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Regardless of the tactics and strategies employed, I would encourage more biopharma professionals to get personally involved in patient engagement programs. A Patient-Centric Month Leads to Results.

Patients 59

Patients Pharma Education Media 59