Biotech | February 27, 2022
VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
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