Belgium
Country
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.
Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.
The aim of the pilot project is to demonstrate that an electronic package leaflet has no negative effects on the proper use of medicinal products in a hospital setting, says the industry body VIG.
While the introduction of joint clinical assessments under the new EU HTA Regulation could be “fruitful,” the bloc should take a more “integrated approach” to enabling access to ATMPs, according to a Belgian HTA expert.
Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.
J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.
“Incomprehensible” is how the industry group Medaxes describes a new annual tax that Belgium plans to impose on companies to address the costs arising from shortages of medicines.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Santhera Pharmaceuticals did not provide enough evidence to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.
Belgian company Hyloris Pharmaceuticals has reported a 44% revenue increase in its 2023 results while doubling down on its long-standing ambition to have 30 portfolio assets in the near future.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Orchard Therapeutics has secured reimbursement in Ireland, the Netherlands and Belgium nearly a year after the collapse of joint pricing talks between the company and the three countries.
Adverse reactions related to consumption of dietary supplements and novel foods in Belgium must be reported by companies within 10 days following the introduction of the new Nutrivigilance system.
France's Biocodex will introduce to European markets a probiotic supplement targeted as sufferers of functional dyspepsia after taking in a stake the product's manufacturer, My Health.
CSL’s Hemgenix is the latest expensive gene therapy to come under scrutiny from the BeNeLuxA cross-country coalition.
Ceres Pharma will grow its presence in Hungary, adding consumer health brands including 1x1 Vitamin and Innopharm supplements and Medistus medical devices, through its acquisition of Budapest's VitaPlus.
New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.
New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.
The European Commission’s proposals for legislative reform in the pharmaceutical sector are welcome but must go further to address patient and societal needs, says a coalition of five EU countries dedicated to improving access to medicines.
ADVERTISEMENT