Regulation & Policy

Amsterdam to be new home for EMA

Amsterdam is to be the new home for the European Medicines Agency following Britain’s decision to leave the European Union, and give up its right to host EU institutions at the end of March 2019. The decision was announced on 20 November by the EU General Affairs Council.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Belgium

New FDA guidance for cells, tissues

The US Food and Drug Administrations has issued four guidance documents explaining how it intends to regulate products derived from human cells and tissues. The guidance updates rules that first took effect in 2005 and includes new incentives for developers of potentially life-saving therapies.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

New drug for CMV after transplants

The European Medicines Agency has recommended a new medicine that can prevent cytomegalovirus (CMV) reactivation and disease in patients who have received an allogeneic stem cell transplant. The medicine, Prevymis (letermovir), was developed by Merck & Co Inc.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United Kingdom

Roche MS drug recommended by EMA

A new monoclonal antibody treatment for multiple sclerosis (MS) has been recommended for approval by the European Medicines Agency following clinical studies that showed significant benefits for patients with both relapsing and primary progressive forms of the disease.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United Kingdom

FDA approves new drug for mantle cell lymphoma

The US Food and Drug Administration has granted an accelerated approval to Calquence (acalabrutinib), a new kinase inhibitor for the treatment of adults with mantle cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

US-EU GMP agreement comes into force

An agreement on the full mutual recognition of pharmaceutical factory inspections was reached on 1 November when the US Food and Drug Administration and the European Commission confirmed that they can now accept one another’s standards.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

Belgium

Second gene therapy approved

The US Food and Drug Administration has approved a second gene therapy to treat cancer, giving a further boost to developers of the new technologies. The approval is for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy to treat adults with certain types of large B-cell lymphoma.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Sales of antibiotic drugs for animals drop

Sales of antibiotic drugs for the treatment of animals has declined in Europe against a backdrop of appeals from public health authorities to curb their use in food-producing species. Overuse of these drugs is linked to a rise in bacterial resistance to existing medicines.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United Kingdom

FDA committee recommends Spark’s gene therapy

Spark Therapeutics Inc’s gene therapy for the treatment of inherited retinal dystrophy has received the unanimous backing of an advisory committee of the US Food and Drug Administration ahead of the agency’s decision on marketing in early 2018.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United States

EMA relocation to be decided on 20 November

The General Affairs Council of the European Union is expected to decide on a new location for the European Medicines Agency on 20 November following the UK’s decision to leave the union, known as Brexit. The EMA is currently based in London.

Full text available to subscribers only. Click here for information on subscribing to MedNous.

Location

United Kingdom

Syndicate content