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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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

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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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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 3D rendering of Antibody Drug Conjugate Molecules.

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Fierce BioTech

MAY 22, 2024

So, how can pharmaceutical and biotech companies enter this market, and how can EAPs support and facilitate future successful commercialization? In addition, EAPs can help serve as introductions to the dizzying array of regulations and guidelines in European countries. On Demand Start Date Tue, 06/25/2024 - 12:00

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DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

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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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The Premier Consulting Blog

APRIL 13, 2025

All of this information will then need to be integrated into comprehensive Weight-of-Evidence (WOE) assessments to justify initially the safety of the drug to enter the clinic and then the overall benefit:risk of the drug for formal marketing approval. 8] ICH Harmonised Guideline S1B(R1) (2022): Testing for carcinogenicity of pharmaceuticals.

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DrugBank

MARCH 15, 2024

According to Grand View Research , the global weight loss and weight management market size was valued at $142.5 Many drug discovery and repurposing initiatives are shifting focus to capturing a share of this market in light of Eli Lilly and the Novo Nordisk success. With sales soaring to $2.2 for this class of drugs.  

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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The Pharma Data

JANUARY 24, 2021

million through the issuance of an aggregate 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules. CRANFORD, N.J. ,

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The Premier Consulting Blog

JANUARY 22, 2024

In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval. The decision of where to launch first requires careful consideration. Degree of novelty. Therapeutic area.

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. With trials facing a median delay of 12.2

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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The Premier Consulting Blog

NOVEMBER 6, 2024

The combination of different active pharmaceutical ingredients (APIs), each with distinct physical and chemical properties, along with the need for precise, efficient drug delivery to the lungs, requires careful CMC planning and execution. ICPs are subject to rigorous regulatory scrutiny due to their complexity.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). 2014 ; Begley et al.

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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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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. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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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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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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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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The Premier Consulting Blog

AUGUST 21, 2024

The major markets follow ICH guidelines, which affords harmonization of a significant portion of the chemistry, manufacturing, and controls (CMC) content. The National Medical Products Administration (NMPA) and the Pharmaceuticals and Medical Devices Agency (PMDA) both follow the CTD format for submissions to China and to Japan, respectively.

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Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments.

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Drug Target Review

OCTOBER 31, 2023

Ashley Hall, CDO of Reneo Pharmaceuticals Throughout my education I was discouraged by many around me. How did that transfer into the pharmaceutical industry? This sector of the pharmaceutical industry combined both my science and law background. I’ve been lucky to have seen several drugs make it all the way to market.

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The Pharma Data

JULY 15, 2021

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION. In addition, the new AstraZeneca American Depositary Shares (ADSs) will be admitted on the Nasdaq Stock Market.

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The Pharma Data

SEPTEMBER 24, 2020

It tested 10 of these products, and found that through consuming recommended serving sizes, participants could be exposed to pharmaceutical-level dosages of drugs. ” These unapproved drugs slip through the regulatory process due to supplements not being strictly regulated by the FDA. Conor Kavanagh. Source link.

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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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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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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 Patent Watch

JANUARY 9, 2025

Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation.

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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. STOCKHOLM , Nov.

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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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DS in Pharmatics

FEBRUARY 24, 2023

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

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