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Geneesmiddelen voor zeldzame ziekten zijn tussen 2012 en 2016 voor meer patiënten vergoed. Ook het bedrag dat zorgverzekeraars voor deze zogeheten weesgeneesmiddelen hebben vergoed is in die jaren flink gestegen. Dat...
First-in-Class OTC Bioelectronic Device for Sinus Pain Gets FDA-Cleared
Tivic Health Systems announced that ClearUP Sinus Pain Relief has been cleared by the Food and Drug Administration (FDA) for the treatment of sinus pain due to allergic rhinitis, or hay fever, in adults aged ≥18 years.
Additional Naloxone Formulation Submitted to FDA for Review
Currently, naloxone is supplied in ampules and vials for IV, IM or SC administration, in a prefilled auto-injector, and as a nasal spray.
Andexxa will go nationwide with FDA nod on Portola’s commercial production of the bleeding antidote
Portola will finally see the commercial release of its universal bleeding reversal agent Andexxa, a milestone not only for the biotech but also for Pfizer and Bristol-Myers Squibb, as well as Bayer and Johnson &...
Researchers evaluate digital medicine tool to treat children with autism and co-occurring ADHD
Researchers at Children’s Hospital of Philadelphia evaluated a digital medicine tool designed as an investigational treatment for children with autism spectrum disorder and co-occurring attention/deficit...
BSE Healthcare index underperforms to BSE Sensex in 2018 and close at 13,923.37 points
BSE Healthcare index of 68 major pharmaceutical and healthcare service companies has declined during 2018 by 5.9 per cent to 13,923.37 on December 31, 2018 from 14,799.42 on the last trading day December 29, 2017.
Luye Pharma to submit NDA for Risperidone ER microspheres for injection with US FDA
Luye Pharma Group, an international pharmaceutical company, announced that the company has entered the final stage of New Drug Application (NDA) submissions for the innovative drug, Risperidone extended release...
Experimenteel onderzoek in Catharina Ziekenhuis voor patiënten met uitgezaaide darmkanker
Het Catharina Ziekenhuis is een onderzoek gestart naar een nieuwe behandeling voor patiënten met uitgezaaide darmkanker in het buikvlies. Deze patiënten, die palliatief worden behandeld, krijgen naast hun reguliere...
PolarityTE seeks US FDA nod for OsteoTE, a human cellular and tissue─based product derived from patient's own bone
PolarityTE, Inc, a commercial─stage biotechnology company, announced that it registered OsteoTE with the US Food and Drug Administration (FDA) pursuant to applicable regulations governing human cells, tissues and...
De knuppel in het data-hoenderhok: ePrivacy Verordening
Zegt het je nog niet veel, de ePrivacy Verordening? Tijd om daar verandering in aan te brengen, want deze specifieke wetgeving gaat binnen anderhalf jaar in, heeft betrekking op alle elektronische communicatie (e-mail...
Edwards Lifesciences receives US FDA approval for SAPIEN 3 Ultra transcatheter heart valve
Edwards Lifesciences Corporation, the global leader in patient─focused innovations for structural heart disease and critical care monitoring, announced that the SAPIEN 3 Ultra system has received US Food and Drug...
Ravicti Approved for Children Under 2 Months With Urea Cycle Disorders
The approval was based on a study that assessed the safety, efficacy, and pharmacokinetics of Ravicti in 16 patients with UCDs less than 2 months of age.
Xynomic Pharma to present phase 3 trial of abexinostat plus pazopanib to treat advanced/metastatic RCC at ASCO symposium
Xynomic Pharma, a clinical stage US-China oncology drug development company, announced that its Trials-in-Progress poster discussing the ongoing, potentially pivotal, phase 3 trial of abexinostat plus pazopanib as first...
Marketing moet in 2019 terug naar de basis
Het is tijd om vooruit te kijken. En als het dan ergens over mag gaan in 2019 is het: terug naar de basis. Laten we weer moeite doen om te begrijpen wat klanten bedoelen of van ons vragen. Laten we zorgen dat we de...
FDA gifts Alexion quick OK for Soliris follow-up Ultomiris
Alexion was expecting a decision on its Soliris successor by February, but thanks to a quick review from U.S. regulators, it’s made its way onto 2018’s list of new drug approvals.
Pfizer, Merck KGaA’s Bavencio takes a hit with second ovarian cancer failure
Back in November, Pfizer and Merck KGaA reported that immuno-oncology drug Bavencio had failed a late-stage ovarian cancer trial. And now the companies can make it two.
Sanofi’s pediatric hexavalent vaccine approved by U.S. FDA
The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases, the French pharmaceutical lab said on Wednesday.
First Digital Inhaler With Built-In Sensors Gets FDA Approval
ProAir Digihaler is the first digital inhaler with built-in sensors that connects to a mobile application and provides data on inhaler use to patients with asthma and chronic obstructive pulmonary disease (COPD).
