Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?

Revision of the Orphan Medicines Regulation

Mike Hennessy Jr. is the Chairman and CEO of 

Cell and gene therapies is unequivocally viewed as the biggest opportunity in the bio/pharma space.

Paradigm Shift

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

Highlights of December 2022 EMA Management Board Meeting 

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

EMA Recommends Five Medicines for Approval

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

Massive Government Spending Bill Tackles Key FDA and Research Issues

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Consent Decree Against Oklahoma Drug Compounder Enters Federal Court

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi). 

Bylvay Alagille Syndrome Submitted for Regulatory Filings to FDA, EMA

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.



Marketing Authorization Application Accepted for Sugemalimab in Metastatic Non-small Cell Lung Cancer

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US. 

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