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Regulation & Policy
Meeting report: regulators debate ‘adaptive licensing’
Tuesday 4 December 2012
Is it possible to envisage a situation where drugs could be approved sooner by a regulatory authority, but for a more restricted use? And if so, would this be a way for pharmaceutical companies to get real-life data on a drug that could then be used to expand the approved indication and satisfy the requirements of a European health authority for reimbursement?
Location
United Kingdom
FDA approves flu vaccine produced in cell culture
Wednesday 21 November 2012
The US Food and Drug Administration has approved a new seasonal influenza vaccine from Novartis – the first vaccine of its kind to be produced using cultured animal cells instead of fertilized chicken eggs.
Location
United States
Meningitis B vaccine gets regulatory nod
Saturday 17 November 2012
The first vaccine to treat Meningitis B infection has been recommended for approval by the European Medicines Agency. Developed by Novartis, the vaccine would help protect all age groups, including infants, against the disease.
Location
United Kingdom
CHMP gives positive opinion to Lyxumia
Friday 16 November 2012
Zealand Pharma A/S’s glucagon-like peptide-1 agonist, Lyxumia (lixisenatide), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for Type 2 diabetes. The drug is partnered with Sanofi SA.
Location
United Kingdom
FDA approves Pfizer’s JAK inhibitor for RA
Thursday 8 November 2012
The US Food and Drug Administration has approved Xeljanz (tofacitinib) a Janus kinase (JAK) inhibitor developed by Pfizer Inc for the treatment of rheumatoid arthritis. The approval represents a new treatment option in a field currently dominated by biologics.
Location
United States
Pharming HAE drug meets primary endpoint
Wednesday 7 November 2012
After a trial delay that triggered a corporate restructuring, Pharming Group NV of the Netherlands has now reported positive clinical data for Ruconest, its lead drug for hereditary angioedema (HAE). A US regulatory filing is expected in the 2013 first half.
Location
Netherlands
Lemtrada trial results published
Thursday 1 November 2012
The Lancet has published two Phase 3 studies of the Sanofi SA multiple sclerosis drug, Lemtrada (alemtuzumab), which show that the antibody significantly reduced relapse rates of the disease compared with the standard of care – Rebif (interferon beta 1a).
Location
France
FDA approves new drug for CML
Friday 26 October 2012
The US Food and Drug Administration has approved a new drug to treat chronic myelogenous leukaemia – the second therapy to be approved for CML in about two months. The drug, Synribo (omacetaxine mepesuccinate), comes from Teva.
Location
United States
EMA starts infringement procedure against Roche
Tuesday 23 October 2012
The European Medicines Agency has started an infringement procedure against Roche for alleged deficiencies in its medicine-safety reporting system. It is the first time the agency has started a procedure of this kind against a company.
Location
United Kingdom
EMA recommends new AD diagnostic
Monday 22 October 2012
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a new diagnostic for patients who are being evaluated for Alzheimer’s disease – the first of its kind.
Location
United Kingdom
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Recent Appointments
Pascale Witz to head strategic development at Sanofi
Monday May 6 2013
Srinivas Akkaraju joins Sofinnova Ventures
Monday May 6 2013
Vicente Anido nominated to Nicox board
Monday May 6 2013
Jeremy Farrar named director of the Wellcome Trust
Monday May 6 2013
Harry Kirsch becomes CFO at Novartis
Monday May 6 2013