FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. The Court thus explained that interpreting the patent in 35 U.S.C.

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DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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thought leadership

MAY 8, 2024

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking registration and market access in the European Union (EU) for their products.

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DrugBank

MARCH 15, 2024

Eli Lilly's Triumph: Pioneering Solutions in Weight Management Eli Lilly's remarkable achievement with its drug Mounjaro (tirzepatide) in the fourth quarter of 2023 has sent ripples of excitement through the pharmaceutical industry. This has caused a great deal of hesitation from pharmaceutical companies in the past.

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thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

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DS in Pharmatics

DECEMBER 12, 2023

There are no holidays or time off when it comes to complying with regulations. Companies always need to be ready to meet the latest standards. With that in mind, new FDA programs are sure to keep pharmaceutical companies of all sizes busy in the year ahead. Here’s how to get through.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

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The Pharma Data

JANUARY 5, 2021

The funds will help advance one of its drug candidates, CPV-101, to stages that will facilitate further investment from venture capitalists and/or pharmaceutical companies. This will enable additional investment from venture capital firms and/or pharmaceutical companies on the path to approval. About Eleva.

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DS in Pharmatics

FEBRUARY 24, 2023

Specialist regulatory affairs consultants offer services to companies operating across this challenging industry. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market. Continue reading to learn how regulatory […]

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

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Drug Target Review

JULY 18, 2023

If we look at the pharmaceutical industry’s discovery and development success rate over the last 20 to 30 years, it has not improved, staying stubbornly at around 10 percent. With support from pharmaceutical companies, ultimately, the answer to this question should be yes. Will systems like the NHS be able to deliver it?

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. a synthetic control arm)?

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The Pharma Data

AUGUST 31, 2020

Company working to ensure broad Canadian access to COVID-19 vaccine candidate, following approval from Health Canada. one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has agreed in principle to supply the Government of Canada with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. August 05, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. New Brunswick, N.J.,

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

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KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. Making drug repositioning a part of therapeutic development is a complicated endeavor relying on interactions between regulatory bodies, pharmaceutical companies, rare disease researchers, and patients.

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The Pharma Data

JANUARY 4, 2021

Drug discovery and development for these drug products is often carried out by academic investigators rather than by biopharmaceutical or pharmaceutical companies, said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, in announcing the draft’s release.

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Crown Bioscience

MAY 4, 2021

Pediatric cancer has been a low priority for pharmaceutical companies due to a combination of factors, including scientific hurdles, additional regulatory burdens, and financial disincentives. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

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The Pharma Data

JANUARY 24, 2021

About Citius Pharmaceuticals, Inc. Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. SOURCE Citius Pharmaceuticals, Inc. .

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Fierce BioTech

JANUARY 19, 2024

Uncover the revolutionary role of video in transforming communication within the pharmaceutical industry and learn how to harness its power effectively. The session will delve into the current digital landscape, featuring case studies on how pharma is leveraging video.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

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Drug Channels

OCTOBER 30, 2023

View the Agenda Snapshot As healthcare stakeholders continue to prioritize the move to value-based care and aim to provide equitable access to care for all, health plan, provider, and pharma leaders must develop novel approaches to empower the patient and ensure effective risk-sharing strategies.

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The Pharma Data

JULY 28, 2021

Additionally, Viviane Monges will join EUROAPI, a future leading European company dedicated to the development, production, and marketing of active pharmaceutical ingredients (API), as an independent non-executive Chair of the Supervisory Board. a multinational dermatology company. She served as Group CFO at Galderma S.A.,

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The Pharma Data

SEPTEMBER 3, 2020

The pre-clinical studies were conducted by researchers from Beth Israel Deaconess Medical Center (BIDMC) in collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson and others as part of its ongoing collaboration to accelerate the development of a SARS-CoV-2 vaccine. Source link.

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Drug Channels

SEPTEMBER 3, 2024

Register Today. Download the brochure.

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The Pharma Data

SEPTEMBER 23, 2020

September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J., Learn more at www.jnj.com.

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ACTO

SEPTEMBER 26, 2023

Understanding the ROI Challenge in Pharma Training Before delving into the potential of personalized learning, it's crucial to understand pharmaceutical companies' challenges when measuring training ROI. Conclusion The pharmaceutical industry is complex, and sales representatives must stay ahead of the curve.

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Broad Institute

MAY 25, 2023

To find genes driving the MONW phenotype, the team employed a variant-to-function framework Claussnitzer has been developing since she was a PhD student for linking non-coding genetic variants to the genes they regulate, the cell types in which they are active, and the biological pathways they affect. Nature Metabolism. Online May 30, 2023.

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The Pharma Data

NOVEMBER 13, 2020

November 14, 2020 – Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S.

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Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1.

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