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MSD has announced the European approval of two of its products for the treatment of HIV: the single-tablet combination Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate), and the non-nucleoside reverse...
US FDA approves Catalyst Pharma’s Firdapse to treat LEMS in adults
LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.
Chinese heparin maker banned by EMA over contamination risks
World regulators are cautious about crude heparin after China-made APIs were responsible for dozens of deaths in the U.S. more than a decade ago. Now, European regulators are banning heparin from a Chinese facility...
FDA: MS Drug Linked to Cases of Stroke, Blood Vessel Wall Tears
Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada.
Bayer announces major restructure, 12,000 jobs to go
Bayer has announced a major restructure of its operations in 2019 which will see the loss of 12,000 of its 118,200 positions following a number of lawsuits in the wake of its $63 billion buyout of agricultural biotech...
Positief advies vier geneesmiddelen
De Europese geneesmiddelenbeoordelingscommissie CHMP heeft een positief advies gegeven over handelsvergunningen voor vier nieuwe geneesmiddelen.
Bayer’s Jivi approved in Europe for previously treated haemophilia A
Bayer has revealed that its recombinant Factor VIII (rFVIII) replacement therapy Jivi, also known as BAY94-9027, has received approval from the European Commission for the treatment and prophylaxis of bleeding in...
‘Meer geneesmiddelen goedkoper na te maken door apothekers’
Er zijn meer dure geneesmiddelen die een stuk goedkoper gemaakt kunnen worden, dan de prijs die een farmaceut ervoor vraagt. Dat zegt de stichting Farma ter Verantwoording, een actiegroep die de hoge prijzen van...
Aethlon Hemopurifier cancer therapy receives US FDA breakthrough device designational
Aethlon Medical, Inc, a therapeutic technology company focused on unmet needs in global health, has received a “Breakthrough Device” designation from the US Food and Drug Administration (FDA) to support the...
Sandoz bags EC marketing approval for biosimilar Ziextenzo
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim).
Korte- en langetermijndenken in marketing
Langetermijneffecten zijn geen optelsom van kortetermijneffecten en campagnes die zich uitsluitend richten op kortetermijnresponse zijn op de lange termijn minder succesvol. De meest succesvolle campagnes combineren een...
De marketingkracht van papier
Als marketeer durf ik het soms bijna niet te zeggen: “Ik maak ook brochures en brieven”. Het voelt als vloeken in de marketingkerk. Maar nu zeg ik het hardop: alle kritiek op dit met uitsterven bedreigde...
Content Marketing alleen succesvol bij een effectieve Customer Journey
De enorme hoeveelheid prikkels die je doelgroep over zich heen krijgt neemt alleen maar toe. Hoe zorg je ervoor dat je in dat enorme reclamelandschap positief opvalt. Niet door vooraan te lopen of te schreeuwen, wel...
Medicijnen tegen hepatitis C worden goedkoper
De prijs van enkele medicijnen tegen hepatitis C wordt verlaagd. Minister Bruins heeft nieuwe afspraken gemaakt met leveranciers. Daardoor worden deze middelen ook volgend jaar vergoed. Over medicijnen tegen hepatitis C...
Roche buys U.S. biotech Jecure in race for liver disease drugs
Swiss drugmaker Roche is buying U.S.-based Jecure Therapeutics, joining Pfizer, Gilead Sciences and Novartis in pursuit of new drugs to treat fatty liver disease.
Vertex posts positive data from cystic fibrosis triple combo trials
Vertex Pharmaceuticals Inc said on Tuesday that its triple combination therapy showed significant improvement in lung function in patients with cystic fibrosis (CF) in two late-stage clinical studies, sending its shares...
Stratasys and Materialise bring 3D printed medical models to life
Further bringing 3D printed medical models to life, Stratasys is expanding the suite of printers and materials validated by its collaborator Materialise as part of FDA-cleared Materialise Mimics inPrint software.
Phase 3 failure of asthma therapy sends Vectura’s ailing shares falling
Vectura has announced it is terminating development of its severe asthma therapy VR475, an inhaled formulation of the corticosteroid budesonide, after it failed in Phase 3 trials to demonstrate a significant impact on...
