Regulation & Policy

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

Novo gets green light for haemopilia B drug

Novo Nordisk A/S has received a positive opinion from the European Medicines Agency (EMA) for its new treatment for haemophilia B, a genetic disorder caused by missing or defective factor IX, a blood clotting protein.

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Location

Denmark

First approved drug for Merkel cell carcinoma

An antibody checkpoint inhibitor has become the first drug to be approved in the US for Merkel cell carcinoma, an aggressive form of skin cancer where fewer than half of patients survive more than one year.

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Location

Germany

Xadago approved to treat Parkinson’s disease in US

Two years after launching in Europe, the Parkinson’s disease drug Xadago (safinamide) has been approved in the US as an add-on treatment to the combination therapy levodopa/carbidopa. The new approval means it will be available in both regions for treating symptoms of the disease such as tremor and impaired mobility.

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Location

Italy

Commentary: Gottlieb tipped as FDA head

President Donald Trump announced on 10 March that he intends to nominate Scott Gottlieb as head of the Food and Drug Administration. Mr Trump has chosen a medical doctor with considerable experience in the politics of medicine, often arguing on television and in print that increasing competition is the way to deal with the medical industry’s complex problems.

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Location

United States

ALK-Abelló sets sights on US

Denmark-based ALK-Abelló A/S is preparing for an expansion of its business in the US following the Food and Drug Administration’s approval on 1 March of its allergy immunotherapy tablet Odactra for adults with house dust mite allergies.

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Location

Denmark

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