Generic drug

Sterne Kessler Secures Non-Infringement Win for Teva Pharmaceuticals

Retrieved on: 
Friday, January 5, 2024
Orange Book, Teva, Syndrome, FDA, The Orange Book, Therapy, Cushing's syndrome, Mifepristone, Type, Corcept Therapeutics, Teva Pharmaceuticals, Patient, Prediabetes, Generic drug

WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.

Key Points: 
  • WASHINGTON, Jan. 5, 2024 /PRNewswire/ -- Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics.
  • On December 29, 2023, the district court held that Teva does not infringe the two patents asserted at trial, finding that Corcept had failed to show that direct infringement is likely or that Teva's label would induce infringement.
  • Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products.
  • Corcept Therapeutics, Inc., the holder of the Korlym NDA, filed a Hatch-Waxman lawsuit against Teva alleging infringement of two patents listed in the Orange Book for Korlym.

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept)

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Wednesday, January 3, 2024
Paratriathlon, Diabetic retinopathy, Macular degeneration, AMD, Macular edema, Patient, Safety, Generic drug

REYKJAVIK, Iceland, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept).

Key Points: 
  • “The progress of our product pipeline clearly illustrates the advantage of our integrated development and manufacturing platform, which allows Alvotech to pursue its diversified global biosimilar strategy,” said Robert Wessman, Chairman and CEO of Alvotech.
  • In the last twelve months before September 30, 2023, cumulative global sales of Eylea were about US$9.4 billion [1].
  • The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in patients with neovascular (wet) AMD.
  • The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Condom, Marketing, HIV-1, Tenofovir disoproxil, INN, Risk, Immune system, Health care, HIV/AIDS, Infection, Mylan, ATC, AIDS, International, Emtricitabine, Blood, Language, European Medicines Agency, Food, HIV, Tablet, Select, Subtypes of HIV, Patient, Cell, NRTI, Anatomy, Medicine, IIA, Pre-exposure prophylaxis, Generic drug

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Teriflunomide Mylan, teriflunomide, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, INN, Immune system, T cell, Multiple sclerosis, ATC, International, Population, Spinal cord, Disease, Ageing, Language, Brain, Inflammation, European Medicines Agency, Medication package insert, Tablet, Select, Cell, Patient, Human, Safety, Anatomy, IIA, Generic drug

Human medicines European public assessment report (EPAR): Teriflunomide Mylan, teriflunomide, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised

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Human medicines European public assessment report (EPAR): Teriflunomide Mylan, teriflunomide, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

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Tuesday, January 2, 2024
Marketing, Artery, Heart, INN, Risk, Hypertension, Population, Embolism, Rivaroxaban, Moyamoya disease, Death, Thrombus, Coronary artery disease, Chest pain, Vein, Facial muscles, Anatomy, ACS, IIA, Knee, ATC, Clopidogrel, DVT, Bleeding, Disease, Ageing, Atrial fibrillation, ASA, Safety, Leg, Medical Subject Headings, Hip, Peripheral artery disease, Pulmonary embolism, Thrombin, Diabetes, International, CAD, Language, Ventricular fibrillation, Tablet, Select, Aspirin, Patient, Acute coronary syndrome, Coronary thrombosis, Blood, Brain, VTE, Recurrence, European Medicines Agency, Ticlopidine, Deep vein thrombosis, PAD, Generic drug

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 3, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, INN, ATC, International, Population, Ageing, Blood, Language, Plasma protein binding, European Medicines Agency, Select, Human, Patient, Bromide, Anatomy, IIA, Generic drug

Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Physician, ATC, EMA, International, Multiple myeloma, Civil service commission, Lenalidomide, Dexamethasone, Bortezomib, Medication package insert, Committee, Patient, Anatomy, Medicine, CHMP, Generic drug

Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.

Key Points: 
  • Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.
  • Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013.
  • Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid.
  • Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.

Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Acute coronary syndrome, Artery, Moyamoya disease, INN, Risk, ATC, Myocardial infarction, Bleeding, International, Blood, Language, Brain, Heart, TIA, Vascular disease, European Medicines Agency, Preventive healthcare, Tablet, ADP, Select, Chest pain, Aspirin, Patient, Anatomy, Medicine, IIA, Atrial fibrillation, Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

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Human medicines European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan), clopidogrel, Date of authorisation: 21/09/2009, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Acute coronary syndrome, Thrombolysis, Artery, Moyamoya disease, INN, Risk, ABCD2, ATC, Myocardial infarction, Bleeding, International, Blood, ASA, Brain, NIHSS, Language, Heart, TIA, Vitamin K, Vascular disease, Percutaneous coronary intervention, European Medicines Agency, VKA, Preventive healthcare, Tablet, ADP, Select, Chest pain, Aspirin, Patient, Anatomy, IIA, Atrial fibrillation, Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

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Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

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Tuesday, January 2, 2024
RNA, Medical Subject Headings, Non-small-cell lung cancer, Marketing, Malignancy, European Commission, Agency, INN, Risk, Histology, ATC, International, European, Lung cancer, Injection, Disease, Body surface area, Language, DNA, Cisplatin, Cancer, Asbestos, Inflammation, Folate, Enzyme, Select, Committee, Patient, Cell, Dehydration, Risk management, Anatomy, Medicine, IIA, CHMP, Generic drug

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised