Regulation & Policy

Drug approved in US for enzyme deficiency

An enzyme replacement therapy, Brineura (cerliponase alfa), has been approved in the US for children with a rare inherited disorder that primarily affects the nervous system. The disorder, tripeptidyl peptidase-1 (TPP1) deficiency, is a form of Batten disease.

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Location

United States

Durvalumab is approved by the FDA

AstraZeneca Plc has received an accelerated approval in the US for its checkpoint antibody Imfinzi (durvalumab), which is expected to be the cornerstone of a prospective portfolio of immune oncology products targeting a variety of cancers.

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Location

United Kingdom

Novartis drug is approved for AML

Novartis has secured US approval for a new kinase inhibitor, Rydapt (midostaurin), to treat patients with FLT3-mutated acute myeloid leukaemia (AML) in combination with chemotherapy. The approval also covers a diagnostic designed to detect the mutation.

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Location

United States

EMA gives positive opinion for Spinraza

The European Medicines Agency has issued a positive opinion for the antisense oligonucleotide medicine Spinraza (nusinersen) to treat patients with spinal muscular atrophy, a rare genetic disease that causes muscle weakness and a progressive loss of movement.

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Location

United Kingdom

Vernalis application turned back by FDA

Vernalis Plc has had its application for the cough-cold medicine CCP-07 turned back by the US Food and Drug Administration, with the result that the product will not reach the US market as quickly as planned.

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Location

United Kingdom

FDA says more data needed for baricitinib

The US Food and Drug Administration has turned back an application from Eli Lilly and Company for baricitinib, a candidate treatment for rheumatoid arthritis, saying that more data is needed to determine the most appropriate doses of the drug for use in patients.

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Location

United States

EMA reaches out to academia

The European Medicines Agency EMA) has formalised its ongoing relationship with universities in order to tap into research that could lead to new medicines and provide regulatory guidance to academic entrepreneurs.

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Location

United Kingdom

Novartis CAR T therapy to get priority review

Novartis has become the second developer to have a candidate chimeric antigen receptor T (CAR T) cell therapy for cancer accepted by the US Food and Drug Administration for review. If successful, the two applications will mark a new era in cancer therapy.

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Location

Switzerland

Ocrevus approved in US for MS

A monoclonal antibody developed by Genentech (Roche) for multiple sclerosis (MS) has been approved for marketing in the US, the first therapy to show a delay in disability for those with progressive forms of the disease. In clinical trials, Ocrevus performed better than Rebif, the standard of care.

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Location

United States

FDA approves new PARP inhibitor

The US Food and Drug Administration has approved a new drug for women with ovarian cancer whose disease has recurred despite treatment with platinum-based chemotherapy. The drug, Zejula (niraparib), is a poly ADP-ribose polymerase (PARP) inhibitor.

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Location

United States

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