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EC fines Teva and Cephalon €60.5 million over pay-for-delay deal
europeanpharmaceuticalreview
November 30, 2020
The European Commission has fined Teva and Cephalon €60.5 million for a pay-for-delay deal over Cephalon’s modafinil and Teva’s generic.
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EC approves Opdivo for treatment of oesophageal squamous cell carcinoma
europeanpharmaceuticalreview
November 27, 2020
The European Commission has approved Opdivo (nivolumab) to treat oesophageal squamous cell carcinoma after studies showed its clinical benefits compared to chemotherapy alone.
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EC announces new Pharmaceutical Strategy for Europe
europeanpharmaceuticalreview
November 27, 2020
The strategy outlines actions to strengthen EU supply chains, encourage innovation and ensure medicines are affordable and sustainable.
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Pacira Receives EC Approval for EXPAREL for Postsurgical Pain
americanpharmaceuticalreview
November 26, 2020
Pacira BioSciences announced the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of ...
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Zymeworks gets EC’s orphan drug designation for zanidatamab in patients with gastric cancer
pharmaceutical-business-review
November 24, 2020
Zymeworks announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer.
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Bristol Myers Squibb get EC approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with chemotherapy for metastatic NSCLC
expresspharma
November 09, 2020
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinoma.
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EC Grants Authorization for ARIKAYCE Liposomal Nebulizer Dispersion for NTM Lung Infections
americanpharmaceuticalreview
November 06, 2020
Insmed Incorporated announced the European Commission (EC) has granted marketing authorization for ARIKAYCE® Liposomal 590 mg Nebulizer Dispersion for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium ...
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EC approves AstraZeneca and Merck’s Lynparza for two cancer types
pharmaceutical-technology
November 06, 2020
AstraZeneca and Merck’s (MSD) Lynparza (olaparib) has secured approval from the European Commission for prostate cancer and ovarian cancer treatments in the European Union (EU).
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EC signs agreement for additional doses of Gilead’s Covid-19 drug
pharmaceutical-technology
October 10, 2020
The European Commission (EC) has inked a joint procurement agreement (JPA) with Gilead Sciences for the supply of up to 500,000 treatment courses of the company’s Covid-19 drug, Veklury (remdesivir).
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EC concludes talks with Pfizer, BioNTech for Covid-19 vaccine supply
pharmaceutical-technology
September 18, 2020
The European Commission (EC) has concluded exploratory talks with Pfizer and BioNTech for the potential supply of 200 million doses of the companies’ BNT162 mRNA-based Covid-19 vaccine candidate to the European Union (EU) Member States.