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Regulation & Policy
FDA approves Sanofi plant
Tuesday 24 January 2012
Sanofi SA has received FDA approval of its plant in Framingham, Massachusetts with the result that it can start restoring supplies of its treatment for Fabry disease. The FDA approval follows earlier approval by the European Medicines Agency.
Location
France
FDA approves first test for risk of PML
Monday 23 January 2012
The US Food and Drug Administration has approved the first diagnostic that will enable healthcare professionals to determine whether a patient taking the multiple sclerosis drug, Tysabri (natalizumab), faces a risk of the brain infection, PML.
Location
United States
New drug for Cushing’s disease gets positive opinion
Friday 20 January 2012
Novartis’s new treatment for Cushing’s disease, a rare hormonal disorder, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Location
United Kingdom
EMA announces safety review of Gilenya
Friday 20 January 2012
The European Medicines Agency has announced the start of a safety review of the Novartis treatment for multiple sclerosis, Gilenya (fingolimod), less than a year after the drug was authorised for marketing in the European Union.
Location
United Kingdom
FDA turns down AZ, BMS diabetes drug
Thursday 19 January 2012
The US Food and Drug Administration has turned down a new treatment for type 2 diabetes, dapagliflozin, the drug’s co-developers, AstraZeneca Plc and Bristol-Myers Squibb Company announced. The drug inhibits sodium-glucose transport proteins known as SGLT2.
Location
United States
Sanofi reports regulatory approval of plant
Wednesday 18 January 2012
Sanofi SA has received European regulatory assurance of the fitness of a manufacturing plant in Framingham, Massachusetts, signaling progress towards the restoration of global supplies of its treatment for Fabry disease, Fabrazyme.
Location
France
Wilex reports on MEK inhibitor
Wednesday 18 January 2012
Wilex AG has reported the successful completion of a Phase 1 study in volunteers of a small molecule inhibitor of the MEK signalling pathway. MEK inhibition is being studied by a number of companies and institutions as a potential anti-cancer agent.
Location
Germany
Clavis Pharma reports delay in AML trial
Wednesday 18 January 2012
Clavis Pharma ASA has announced a delay in the start of a Phase 3 study of its new treatment for acute myeloid leukaemia (AML). Separately, the Norwegian oncology company said it has raised NOK 163 in a private share placement with investors.
Location
Norway
FDA tightens label on antibody-drug conjugate, Adcetris
Monday 16 January 2012
Just six months after approving Adcetris (brentuximab vedotin), the US Food and Drug Administration has announced that the developer, Seattle Genetics Inc, will be tightening the drug’s label to warn against the rare PML brain infection.
Location
United States
Basilea to seek European approval for antibiotic
Thursday 5 January 2012
After regaining rights to the broad-spectrum antibiotic, ceftobiprole, Basilea Pharmaceutica Ltd has announced plans to file a European marketing authorisation application in the second half. Talks with the FDA are ongoing about a US filing.
Location
Switzerland
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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