Ga direct naar de inhoud

Ga direct naar de navigatie

Uitgave van

Archief voor de categorie ‘Toezicht’

From pipeline to patients: Navigating treatments through the UK system

Pharmafocus spoke to Karen Lightning-Jones, Integrated Franchise Leader, Pipeline, to discuss the current UK climate for successfully developing drugs to provide to patients, covering what is needed by the next government and how Switzerland provides a model to thrive outside the EU.

Bron: Pharmafile Meer lezen »

Animaties tonen verspreiding nieuwe medicijnen

Animaties zijn een goede manier om inzicht te krijgen in de verspreiding van nieuwe geneesmiddelen. Dit kan beleidsmakers helpen gerichte actie te ondernemen. Onder leiding van het Instituut voor Verantwoord Medicijngebruik (IVM) zijn in het pilotproject MOVIE animaties gemaakt voor nieuwe antistollingsmiddelen en nieuwe geneesmiddelen tegen diabetes.

Bron: Medicalfacts Meer lezen »

FDA to review effectiveness of abuse deterrent opioid drugs

FDA Commissioner Scott Gottlieb continues his fightback against the US opioid crisis after requesting an unprecedented recall of Endo Pharmaceuticals’ painkiller Opana ER by calling for a review of all ‘abuse deterrent’ opioid drugs to confirm their efficacy at preventing addiction and abuse.

Bron: Pharmafile Meer lezen »

Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs. triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.

Bron: Monthly Prescribing Reference (MPR): Drug News Meer lezen »

European Medicines Agency: Staying consistent in a turbulent time

With Brexit looming, the future of the EMA headquarters in London has been cast in doubt. Pharmafocus spoke to Marie-Agnes Heine, Head of the Communication Department, and Juan García Burgos, Head of the Public Engagement Department, to discuss the medical communication role within the organisation and how the department is busier than ever.

Bron: Pharmafile Meer lezen »

FDA Approves First Generic Version of Truvada

The Food and Drug Administration (FDA) has approved Teva’s Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg, the first generic version of  Gilead’s Truvada 200mg/300mg. Teva’s product was determined to be bioequivalent and therapeutically equivalent to the reference drug.

Bron: Monthly Prescribing Reference (MPR): Drug News Meer lezen »

New FDA commissioner Gottlieb unveils price-fighting strategies

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices.

Bron: FiercePharma Meer lezen »

Merck’s Keytruda picks up a trifecta with FDA approval to treat rare tumor type

Talk about going on a roll. Merck’s Keytruda nabbed its third FDA approval in two weeks on Tuesday, becoming the first checkpoint inhibitor to pick up an approval to treat microsatellite instability-high cancer, a rare tumor type identified with genetic testing.

Bron: FiercePharma Meer lezen »

Opioid crisis “highest initial priority” for new FDA Commissioner

Scott Gottlieb, the newly appointment FDA Commissioner, has indicated that his first priority is to tackle the opioid crisis currently wracking the US, through messages on the FDA blog and in an internal email to FDA employees. He stated that the agency needed to examine what “additional, forceful steps” it could take to address the […]

Bron: Pharmafile Meer lezen »

Drugs approved with limited data aren’t always well-tested later

New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren’t always proven to work after they go on sale, a recent research review suggests. Researchers focused on medicines approved for sale based on single pivotal trials or based on what’s known as “surrogate markers”.

Bron: Reuters Meer lezen »

« Oudere artikelen |