Round-up of Early Clinical Trials
Evotec starts Phase 2 depression study
Regulation & Policy
EMA says Fabrazyme supply problems continue
The European Medicines Agency has issued a second warning about supply problems for the Genzyme Corp drug, Fabrazyme (agalsidase beta), for Fabry disease. It is recommending that, where possible, an alternative treatment be used.
EMA proposes new fee structure
The European Medicines Agency is proposing a new method for calculating the fees that it charges to industry for its services. The fee structure would be simplified, with fewer fees charged for applications for a marketing authorisation.
Pharming receives positive opinion for Rhucin
The Pharming Group NV said that its recombinant human C1 inhibitor for hereditary angioedema, Rhucin, has received a positive opinion from the European Medicines Agency. This ends a three-year effort to gain regulatory approval for the drug.
SkyePharma gives update on talks with FDA
SkyePharma Plc said it is reviewing all of its options following a meeting with the US Food and Drug Administration during which the agency outlined the work that would be required to meet its approval criteria for Flutiform, an asthma drug.
Pfizer suspends tanezumab osteoarthritis clinical programme
At the request of the US Food and Drug Administration, Pfizer Inc has suspended the clinical development programme for its investigational compound for osteoarthritis, tanezumab. The clinical hold follows reports of adverse events.
Commentary: Europe has the power to harmonise HTA data, but will it do so?
Experts say that existing European law permits the establishment of common criteria for determining the relative effectiveness of licensed drugs. But will it happen?
FDA approves first diagnostic for HIV antigen and antibodies
The US Food and Drug Administration said that it has approved the first diagnostic assay to detect both antigen and antibodies to the Human Immunodeficiency Virus (HIV). Most current tests detect HIV antibodies only.
Pharma cuts capacity, but the pendulum can’t swing too far – Andrew Witty
Despite downward pressure on drug prices, Big Pharma needs to keep enough research capacity in the system so that it can produce the medicines that patients will need in the future, according to Andrew Witty, chief executive officer of GlaxoSmithKline, and incoming president of the European Federation of Pharmaceutical Industries and Associations (Efpia).
Clinical trial data likely to be made public
Regulatory authorities in the US and Europe are taking steps to make more clinical trial data available to the public, possibly including information on the results of these trials, speakers at the Drug Information Association said on 16 June 2010