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Switzerland’s medicines authority said last month that it will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved there. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
The EU Parliament advanced major data privacy legislation, but not before amending two provisions that pharma companies had said would cripple clinical research. Read More
The European Medicines Agency March 11 published the first risk-management plan summary for Piramal Imaging’s molecular imaging agent NeuraCeq (florbetaben (18F)), used to detect ? amyloid plaques in the brain, a protein associated with Alzheimer’s disease. Read More
GlaxoSmithKline says it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
The UK’s health cost-benefit watchdog is developing new “burden of illness” and “societal impact” measurements to use when assessing new drugs for government reimbursement. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More
The European Medicines Agency has launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More
Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer. Read More
Indian drug regulators have suspended distribution of three drug products made by Wockhardt, the company announced Wednesday, adding to sanctions it already faces from the FDA and UK regulators. Read More