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‘Digital Pill’ tells doctor when patient takes it

The first drug designed to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.

Bron: Drug Information Online Meer lezen »

Nederlander wordt hoofd consumentendivisie farmaceut Bayer

De Duitse farmaceut Bayer heeft de Nederlander Heiko Schipper benoemd tot hoofd van de consumentendivisie. De 48-jarige bestuurder, die nu nog bij het Zwitserse Nestlé werkt, begint op 1 maart aan zijn nieuwe baan.

Bron: Skipr Meer lezen »

Boehringer celebrates EU approval of Humira biosimilar

Boehringer Ingelheim has announced that Cyltezo, its biosimilar of Abbvie’s Humira, has received marketing authorisation approval from the European Commission, confirming that is comparable in safety and efficacy to its originator product.


Bron: Pharmafile Meer lezen »

Loxo, Bayer to co-develop cancer drugs in up to $1.55 billion deal

Loxo Oncology Inc will collaborate with Germany’s Bayer AG to develop and commercialize two of its cancer therapies, the companies said on Tuesday, in deal that could bring the U.S. drug developer up to $1.55 billion.

Bron: Reuters Meer lezen »

Navigating the new Clinical Trial Regulation with DIA

For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials.

Bron: Pharmafile Meer lezen »

Novartis targets specific patient population with strong Ilaris Phase 3 data

Novartis has presented new Phase 3 data on its cardiovascular drug Ilaris (canakinumab) which demonstrate particular efficacy in a specific subgroup of the trial’s patient population – a subgroup which the Swiss drugmaker is now looking to target with the drug.

Bron: Pharmafile Meer lezen »

EMA Headquarters: There’s no place like home

With the result of the Brexit referendum, the future of the EMA’s London headquarters was cast in doubt. Now, 19 EU member states are bidding to become the new home of the agency. It’s now only one week away from the decision as to which city will host the agency and the competition is fierce.

Bron: Pharmafile Meer lezen »

EMA recommends approval of Roche’s Ocrevus in relapsing forms of multiple sclerosis

Roche has revealed that its humanised monoclonal antibody Ocrevus (ocrelizumab) received a positive recommendation from the Committee for Medical Products for Human Use (CHMP) in the treatment of active relapsing forms of multiple sclerosis.

Bron: Pharmafile Meer lezen »

Novartis touts longer-lasting AMD rival to Eylea

NovartisNovartis posted strong results for its wet age-related macular degeneration (AMD) drug, by showing superiority against Eylea in Phase 3 trials. The data sets Novartis up to take a chunk of the nearly $5 billion that Eylea and Lucentis, the leading products in the market, reap annually.


Bron: Pharmafile Meer lezen »

Hep-B vaccine four-year battle for FDA approval is finally won

Dynavax had said it was the last throw of the dice for its hepatitis B vaccine, Hepislav-B – the data pointed to it entering the market as best-in-class but it had received one knock-back after another, culminating in a final three month user fee action data delay.


Bron: Pharmafile Meer lezen »