The Pharma Data

MAY 8, 2021

The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. Our ambition is to be the world’s leading and most valued generics company.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Pharmaceutical Technology

FEBRUARY 18, 2023

Novartis Overview Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. The company offers generic medicines and biosimilars through Sandoz.

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Pharmaceutical Technology

DECEMBER 22, 2022

Blueprint Medicines wins the Financing award this year after securing significant financing partnerships worth up to $1.25bn. Be Bio Blueprint Medicines Endeavor BioMedicines Kallyope Metagenomi Mineralys Neuron23 Nutcracker RayzeBio Rivus Ventus Therapeutics. Innovation.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. billion.

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The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Source link: [link].

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XTalks

JUNE 8, 2022

In a press release , the company says the goal of the Act4Biosimilars campaign is to help “address global health inequity and inequality” by increasing access to advanced medicines like biosimilars. This will be made achievable by improving the approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars.

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

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The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. billion.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. Today, the U.S.

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Pharma in Brief

SEPTEMBER 19, 2023

Background All three decisions arose during proceedings commenced pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ).

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The Pharma Data

MAY 18, 2021

By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. billion.

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The Pharma Data

MAY 15, 2023

Shamiram holds an AB from Smith College and Doctor of Medicine as well as a Master of Public Health, both from Emory University, U.S.A. About Novartis Novartis is reimagining medicine to improve and extend people’s lives. Our ambition is to be the world’s leading and most valued generics company. billion.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In recent years, GSK has seen significant achievements, with over 20 new medicines and vaccines approved. 13) Takeda Pharmaceutical By: Vincent Xie, M.Sc.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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FDA Law Blog

JANUARY 24, 2024

API production; (2) Criteria for selection of essential medicine small molecule APIs for manufacture; (3) Barriers to reshoring small molecule API manufacturing; and (4) Ways to build a resilient drug supply chain. generic pharmaceutical industry, resulting in low profit-margins.

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