Generic drug

ARCHIMEDES ANNOUNCES BIOSIMILARS FIRST™, AN INDUSTRY LEADING PROGRAM TO DRIVE BIOSIMILAR ADOPTION IN 2024

Retrieved on: 
Thursday, January 11, 2024
WAC, PBM, Patient, Publishing, Social media, Pharmacy, FDA, Physician, Generic drug

BRENTWOOD, Tenn., Jan. 11, 2024 /PRNewswire/ -- Archimedes, a recognized leader in specialty drug management solutions, announced BiosimilarsFirst™, a program, which excludes Humira from formulary in favor of low cost, low WAC biosimilars.

Key Points: 
  • BRENTWOOD, Tenn., Jan. 11, 2024 /PRNewswire/ -- Archimedes, a recognized leader in specialty drug management solutions, announced BiosimilarsFirst™, a program, which excludes Humira from formulary in favor of low cost, low WAC biosimilars.
  • BiosimilarsFirst is projected to drive industry-leading adoption of biosimilars for autoimmune diseases, providing plan sponsor savings of 65% plus and more affordable treatment options for patients.
  • Archimedes' BiosimilarsFirst program stands in direct contrast to the PBM market's approach by preferring low cost biosimilars and excluding both brand and high cost biosimilars.
  • As evidence to this, Archimedes' Biosimilar Fill Rate™ was 94% in 2023 for drugs that had a biosimilar available throughout all of 2023.

Kirby McInerney LLP Announces Pendency of Class Action and Proposed Settlement Involving Purchasers of Reata Pharmaceuticals, Inc. Common Stock

Retrieved on: 
Monday, January 8, 2024
Prejudice, Claim, Action, Clerk, Agreement, Person, Court, CLASS, Notice, Hearing, Reata Pharmaceuticals, ARE, READ, Release, Lawsuit, Class Action, Settlement, Lasso, Counsel, District court, Motion, Certification, Generic drug

PLEASE READ THIS NOTICE CAREFULLY, YOUR RIGHTS WILL BE AFFECTED BY A CLASS ACTION LAWSUIT PENDING IN THIS COURT.

Key Points: 
  • PLEASE READ THIS NOTICE CAREFULLY, YOUR RIGHTS WILL BE AFFECTED BY A CLASS ACTION LAWSUIT PENDING IN THIS COURT.
  • YOU ARE ALSO NOTIFIED that Lead Plaintiff in the Action has reached a proposed settlement of the Action for $45,000,000 in cash (the "Settlement"), that, if approved, will resolve all claims in the Action.
  • If you are a member of the Settlement Class, your rights will be affected by the pending Action and the Settlement, and you may be entitled to share in the Settlement Fund.
  • All questions about this notice, the proposed Settlement, or your eligibility to participate in the Settlement, should be directed to Lead Counsel or the Claims Administrator.

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)

Retrieved on: 
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

Retrieved on: 
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

Retrieved on: 
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

Key Points: 


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

Retrieved on: 
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

Retrieved on: 
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

Retrieved on: 
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

Retrieved on: 
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

Key Points: 


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