Regulatory/GMP Compliance, Europe

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

What impact will the AI Act have on pharma and digital medicine?

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Innovative solutions are making personalized cell and gene therapies accessible to all.

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

The EHDS aims to increase access to health data, but how will it impact pharma?

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.