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MSD’s Keytruda scores EU approval in certain oesophageal cancer patients
pharmatimes
July 02, 2021
MSD’s immunotherapy Keytruda has received approval from the European Commission (EC) in combination with chemotherapy as a first line treatment for certain oesophageal cancer patients.
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EC approves Chugai’s Enspryng for NMOSD treatment
pharmaceutical-technology
June 29, 2021
The European Commission (EC) has approved Chugai Pharmaceutical’s Enspryng (satralizumab) to treat anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD).
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EC Approval for Opdivo Plus Yervoy as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma
americanpharmaceuticalreview
June 04, 2021
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
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EC authorises Diurnal’s Efmody for CAH
pharmatimes
June 02, 2021
The European Commission (EC) has approved UK-headquartered pharma company Diurnal’s Efmody for the treatment of congenital adrenal hyperplasia (CAH).
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EC approves Ponvory for relapsing MS
pharmatimes
May 26, 2021
The European Commission (EC) has cleared Janssen’s Ponvory for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease.
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EC to procure 1.8 billion doses of Pfizer-BioNTech’s Covid-19 vaccine
pharmaceutical-technology
May 24, 2021
The European Commission (EC) has signed a new contract with BioNTech and Pfizer to procure additional 1.8 billion doses of their Covid-19 vaccine, Comirnaty, between this year end to 2023.
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EC approves new Sarclisa indication
pharmatimes
April 20, 2021
The European Commission has approved Sanofi’s Sarclisa in combination with standard of care regimen carfilzomib and dexamethasone (Kd) for the treatment of relapsed multiple myeloma.
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EC approval for Ontozry
pharmatimes
April 07, 2021
Angelini Pharma has announced European Commission (EC) approval for anti-seizure drug Ontozry (cenobamate).
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EC approves Novartis’s Kesimpta for relapsing multiple sclerosis
pharmaceutical-technology
April 01, 2021
The European Commission has approved Novartis’s Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features.
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Dynavax secures EC marketing authorisation for hepatitis B vaccine
pharmaceutical-business-review
February 25, 2021
Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.