Negative Recommend. (Panels)
07-20-2010 |
18:54 hs.
A Food and Drug Administration panel gave a negative recommendation for Roche Holding AG cancer drug, Avastin (Bevacizumab), the leading company´s product will no longer be prescribed as breast cancer treatment. The 12 to 1 votation ended Avastin as an option for breast cancer drug.
07-20-2010 |
12:42 hs.
An FDA independent advisory panel, rejected approval of Vivus Inc. experimental weight-loss drug, Qnexa (Phentamine + Topiramate).
FDA Panel: Negative Recommendation for Respiratory Syncytial Virus Dis
06-27-2010 |
14:47 hs.
The Food and Drug Administration decided to delay final decision for approval of AstraZeneca Plc. monoclonal antibody drug Motavizumab, indicated to treat serious respiratory syncytial virus disease.
Novartis Oral Drug
06-08-2010 |
20:18 hs.
According to Food and Drug Administration regulators, Novartis AG, multiple sclerosis oral drug Gilenia (Fingolimod) has not met beneficial criteria its benefits are outweigh its risks.
AstraZeneca Plc. Drug
06-03-2010 |
16:02 hs.
A Food and Drug advisory panel, gave negative recommendation on the approval of AstraZeneca Plc. drug Motavizumab, indicated to treat Respiratory syncytial virus. The drug was pointed out as Synagis (Palivizumab) successor, was originally submitted for approval on 2008.
Diffuse Large B-Cell Lymphoma (DLBCL).
06-03-2010 |
15:38 hs.
Roche Holding AG decided to stop enrollment of Avastin (Bevacizumab)+ Rituxan/MabThera (Rituximab) +ChemotherapyCHOP (Cyclophosphamide + Doxorubicin + Vincristine + Prednisone) Phase III clinical trial on patients with Diffuse Large B-Cell Lymphoma (DLBCL).
Negative Recommendation
04-08-2010 |
17:30 hs.
An FDA advisory panel does not recommend approval of Nycomed A/S and Forest Laboratories Inc. experimental drug Daxas (Roflumilast) indicated to treat chronic obstructive pulmonary disease (COPD).
07-25-2008 |
13:13 hs.
Sanofi-Aventis´s blockbuster
07-25-2008 |
11:53 hs.
The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMEA) advisory panel, has recommended against the extended use of Sanofi Aventis´ drug Taxotere as an HER2 positive breast cancer treatment, the London-based watchdog announced.
06-02-2008 |
13:06 hs.
An EMEA advisory panel has recommended against approval of Takeda Pharmaceutical’s insomnia drug Ramelteon for adults. This is yet another blow to the Japan-based drugmaker, who is seeking to compete against Sanofi Aventis’ sleep aid drug Ambien
Hemopure
04-07-2008 |
12:51 hs.
Velcade
03-24-2008 |
09:41 hs.
The European Medicines Agency (EMEA) recommended that Millennium Pharmaceuticals’ cancer drug injection Velcade (bortezomib) should not be used in patients with certain severe pulmonary or heart problems. Treatment had already been approved in the U.S. and Europe for patients with multiple myeloma who have received at least one prior therapy
Injectable Anaemia Drug
03-12-2008 |
08:32 hs.
U.S. regulators have rejected Daiichi Sankyo Co injectable anaemia drug Injectafer for the broad treatment of uterine bleeding. Also, the FDA Advisory Panel had voted in February against recommending broad use of the drug but said the benefits outweighed the risks for women who could not tolerate oral iron or had an unsatisfactory response to it.


