Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry.

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ACTO

DECEMBER 17, 2024

Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

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.

Pharmaceutical Companies 59

Pharmaceutical Companies FDA Production Regulations 59

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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SugarCone Biotech

JUNE 27, 2025

Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets. Each target and each therapeutic modality induces varying degrees of clinical efficacy, as well as causing toxicities.

Therapies 64

Therapies Pharmaceutical Companies Trials Regulations 64

DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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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.

Marketing 59

Marketing Pharmaceutical Companies Regulations Pharmaceuticals 59

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.

Pharmaceutical Companies 59

Pharmaceutical Companies Compliance Pharmaceuticals Regulations 59

The Pharma Data

JUNE 6, 2025

The Strategic Role of CSOs in a Changing Pharmaceutical Landscape Pharmaceutical contract sales outsourcing is no longer viewed as a temporary or stop-gap measure. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

Pharmaceutical Companies 40

Pharmaceutical Companies Compliance Pharmaceuticals International 40

DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity.

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The Pharma Data

JUNE 25, 2025

Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc. , a biotechnology firm known for its expertise in microRNA-targeting therapies.

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RNA Clinical Trials Disease Small Molecule 52

DrugBank

MARCH 15, 2024

Mounjaro distinguishes itself from other treatments on the market by being the first to simultaneously activate GIP and GLP-1 pathways, offering a novel approach to regulating blood sugars for people with Type 2 Diabetes. This has caused a great deal of hesitation from pharmaceutical companies in the past.

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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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Pharmaceutical Companies FDA Regulations Pharmaceuticals 59

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.

Pharmaceutical Companies 59

Pharmaceutical Companies International Regulations Pharmaceuticals 59

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.

Therapies 52

Therapies Treatment Clinical Trials Science 52

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.

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceutical Companies 52

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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Drug Patent Watch

FEBRUARY 17, 2025

The generic drug approval process is a complex, multi-step journey that involves several stakeholders, including pharmaceutical companies, regulatory agencies, and healthcare professionals. The journey to approval is often shrouded in mystery, but it's a crucial process that affects millions of people worldwide.

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Packaging Drugs FDA Pharmaceutical Companies 52

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. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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 […]

Pharmaceutical Companies 52

Pharmaceutical Companies Regulations Drug Development Pharmaceuticals 52

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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Pharmaceutical Companies Pharmaceuticals Regulations Drugs 52

Drug Patent Watch

JANUARY 14, 2025

Key Stakeholders in Pharmaceutical Negotiations Successful negotiations in the pharmaceutical industry require a deep understanding of the various stakeholders involved. These may include: Pharmaceutical companies (big pharma and biotech firms) Contract research organizations (CROs) Regulatory bodies (e.g.,

Pharmaceuticals 54

Pharmaceuticals Compliance Licensing Licensing 54

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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Compliance Science Regulations Pharmaceutical Companies 59

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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PPD

AUGUST 16, 2023

The study’s objective was to supplement the findings of PPD surveys conducted in 2020 and 2021 that examined similar issues from the perspective of sponsor pharmaceutical companies. Fortunately, leading global regulators have launched key initiatives.

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Clinical Trials Trials Clinical Research FDA 98

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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Drug Target Review

JULY 18, 2023

Alongside that, there is a need for some regulatory changes, or creative approaches to reviewing data packages, but regulators are well aware of that, and seem to be quite adaptive to change.” With support from pharmaceutical companies, ultimately, the answer to this question should be yes.

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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.,

Government 52

Government Vaccine Pharmaceutical Companies Pharmaceuticals 52

Drug Patent Watch

JANUARY 14, 2025

”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. The Plot: Generic vs. Brand-Name Two major pharmaceutical companies sued over 10 generic drug manufacturers for infringing on a patent for their schizophrenia medication[4].

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Drug Development Drugs FDA Production 71

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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Production FDA Pharmaceutical Companies Drugs 52

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.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

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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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.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

ACTO

DECEMBER 17, 2024

Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

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.

Pharmaceutical Companies 74

Pharmaceutical Companies Regulations Pharmaceuticals Drugs 74

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.

Disease 87

Disease Regulations Pharmaceutical Companies DNA 87

Fierce BioTech

JANUARY 19, 2024

Explore the shifts the digital and social landscape that have led to the rise and boom of video content on social media platforms Gain insights into real-world case studies showcasing how pharmaceutical companies are effectively utilizing video to revolutionize communications Consider the challenges and strategies for navigating regulatory hurdles (..)

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