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Libtayo (cemiplimab) Receives Positive CHMP Opinion for the Treatment in Europe of Two Advanced…

May 24, 2021
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for…
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Three weeks to go until Pre-filled Syringes West Coast Virtual Conference 2021 – Registration…

May 24, 2021
SMi reports: Have you secured your place at Pre-filled Syringes West Coast 2021 conference returning as a virtual event in June? Now only 3 weeks away there are limited places…
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EMA issues positive scientific opinion on GSK and Vir Biotechnology’s sotrovimab for the early…

May 24, 2021
GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific…
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AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan

May 24, 2021
AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S ), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18…
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FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

May 24, 2021
The U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of…
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Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan

May 21, 2021
Takeda Pharmaceutical Company Limited announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under article 14-3 of the Pharmaceuticals and Medical…
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AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan

May 21, 2021
AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S ), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18…
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Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Pivotal Clinical Trial of…

May 20, 2021
Sorrento Therapeutics, Inc. announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 Pivotal clinical trial of COVI-MSC™, an injectable…
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GSK announces sale of stake in Innoviva Inc

May 20, 2021
GlaxoSmithKline has agreed with Innoviva, Inc (“Innoviva”) - a royalty management company - to sell all of its approximately 32 million shares of common stock of Innoviva back to…
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Arecor Announces an Exclusive Formulation Study Collaboration With Lilly

May 20, 2021
Arecor Limited the biopharmaceutical company advancing therapies to enable healthier lives,  announces that it has signed a formulation study partnership with Eli Lilly and Company…
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