Search
Immunoglobulin shortages in the spotlight: EMA, SUPPLY and the SoHO Regulation
EMA executive director Emer Cooke welcoming participants including EHA at the Shortages Workshop, March 1
Shortages of immunoglobulins and the need to increase and sustain plasma supplies have moved to the center of the EU policy and regulatory stage.
Stopping tyrosine kinase inhibitors in a very large cohort of European chronic myeloid leukemia patients: results of the EURO-SKI trial
Tyrosine kinase inhibitors (TKI) have substantially improved survival in patients with chronic myeloid leukemia in chronic phase. However, treatment is in clinical practice considered life-long.
Read moreClinical trials
The advance of highly innovative, increasingly personalized therapies in hematology requires novel clinical trial designs and more flexible, adaptive regulatory frameworks and improved data generation to support decision making both during and after clinical studies.
Read moreAddressing immunoglobulin shortages: EHA and EBA’s strategic recommendations at the EMA
In recent years, shortages of immunoglobulins (Ig) have become a growing concern in the European Union (EU). Since 2018, the European Medicines Agency (EMA)—the EU agency that evaluates and supervises medicines—has received an increasing number of shortage reports.
Read moreIVDR
As of May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect.
Read moreTreatment and survival of patients with chronic myeloid leukemia (CML) in Europe
Since the introduction of tyrosine kinase inhibitors into the treatment of CML survival times have greatly improved.
Read moreUrgent action needed to avoid widespread shortage of in-vitro diagnostic tests
In a new statement, BioMed Alliance highlights its increasing concern about the availability of In Vitro Diagnostic (IVD) testing devices in Europe.
Read moreEU Parliament agrees on pharmaceutical legislation stance
On April 10, the European Parliament adopted its position on the revision of the EU pharmaceutical legislation.
Read more- «
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18
- 19
- 20
- 21
- 22
- 23
- 24
- 25
- 26
- 27
- 28
- 29
- 30
- 31
- 32
- 33
- 34
- 35
- 36
- 37
- 38
- 39
- 40
- 41
- 42
- 43
- 44
- 45
- 46
- 47
- 48
- 49
- 50
- 51
- 52
- 53
- 54
- 55
- 56
- 57
- 58
- 59
- 60
- 61
- 62
- 63
- 64
- 65
- 66
- 67
- 68
- 69
- 70
- 71
- 72
- 73
- 74
- 75
- 76
- 77
- 78
- 79
- 80
- 81
- 82
- 83
- 84
- 85
- 86
- 87
- 88
- 89
- 90
- 91
- 92
- 93
- 94
- 95
- 96
- 97
- 98
- 99
- 100
- 101
- 102
- 103
- 104
- 105
- 106
- 107
- 108
- 109
- 110
- 111
- 112
- 113
- 114
- 115
- 116
- 117
- 118
- 119
- 120
- 121
- 122
- 123
- 124
- 125
- 126
- 127
- 128
- 129
- 130
- 131
- 132
- 133
- 134
- 135
- 136
- 137
- 138
- 139
- 140
- 141
- 142
- 143
- 144
- 145
- 146
- 147
- 148
- 149
- 150
- 151
- 152
- 153
- 154
- 155
- 156
- 157
- 158
- 159
- 160
- 161
- 162
- 163
- 164
- 165
- 166
- 167
- 168
- 169
- 170
- 171
- 172
- 173
- »