STAT

MAY 30, 2023

LONDON — A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug’s chances of entering the European market.

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Express Pharma

NOVEMBER 1, 2023

As the report sums up, it is clear that future profit margins and growth strategies of Indian pharma companies will hinge on their ability to navigate regulatory inspections successfully. The caveat to this rosy picture is concerns with respect to adverse observations if any from regulatory authorities.

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Express Pharma

DECEMBER 29, 2023

Therefore, Express Pharma is launching “Regulatory Watch” a series of Master Classes led by experts and thought leaders to empower you with the knowledge and insights needed to navigate the ever-changing regulatory landscape successfully. In this ever-changing environment, continuous learning is key.

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STAT

OCTOBER 28, 2022

One of the most pressing concerns involves what constitutes “regulatory grade” real-world data and real-world evidence, and when sponsors need to ensure that research conducted using data other than those generated via clinical trials meets the definition of regulatory grade.

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European Pharmaceutical Review

APRIL 2, 2024

Pharmacopoeia guidance on recombinant BET methods Currently, the regulatory landscape surrounding the use of (rFC) and (rCR) can be complex and confusing. Additionally, there are positive regulatory developments on the horizon. It is important to understand the guidance provided by different pharmacopoeias.

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Method Validation Medical Schools 91

PharmaState Academy

FEBRUARY 29, 2024

CASE STUDY The Regulatory Riddle Unraveling Sales Strategies in the Pharmaceutical Jungle Table of Contents Case Study Scenario: In the heart of XYZ Pharma’s bustling headquarters, the sales team gathers for a crucial meeting that could shape the future of the company.

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Big Molecule Watch

DECEMBER 26, 2023

Food and Drug Administration (FDA) and the Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA). The post CRISPR Regulatory Updates appeared first on Big Molecule Watch.

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European Pharmaceutical Review

JANUARY 4, 2024

concluded that updating regulatory guidelines and developing relevant standards and guidelines to accommodate the development of these systems “are essential to reduce the associated costs and allow off-the-shelf solutions to be developed.” Borgosz et al. To facilitate the adoption of IIoT systems in bioprocessing, Borgosz et al.

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PharmExec

APRIL 9, 2024

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, talks about the ethical and regulatory problems weight loss companies like WW, Noom, and Ro present.

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European Pharmaceutical Review

APRIL 25, 2023

Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Ghana’s regulatory approval is a vital step in helping to reduce over half a million malaria-related deaths annually, stated the institution.

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European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The European regulatory body amended Q&A 10 and added three appendices. Cioc et al.

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pharmaphorum

DECEMBER 1, 2023

How to advance more late-stage neuroscience drugs to regulatory approval Mike.Hammerton Fri, 01/12/2023 - 09:00 Bookmark this

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PharmaTech

APRIL 29, 2024

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

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Compounding Controlled Substances Drug Development 111

PharmaVoice

AUGUST 4, 2023

From Congress to the FTC to state legislatures, regulators are cracking the whip against PBMs.

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PharmaState Academy

AUGUST 22, 2023

The winner will be announced on 27th Aug (Sunday) in the Upcoming Career Counseling Session on the Topic: "Regulatory Affairs". Regulatory Affairs Quiz Competition Learn more about how effective regulatory affairs management is transforming the pharmaceutical industry’s compliance landscape and innovation journey.

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Express Pharma

APRIL 6, 2023

Nutraceutical startups in India face a complex and evolving regulatory landscape. Challenge 1: Unclear regulatory framework The regulatory framework for nutraceuticals in India is complex and evolving. Startups often struggle to understand the regulations and requirements, which can lead to delays and non-compliance.

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Drug Patent Watch

AUGUST 15, 2023

Over the past three decades, biotherapeutics have revolutionized healthcare by providing effective treatments for complex diseases… The post Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review appeared first on DrugPatentWatch - Make Better Decisions.

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Biosimilars 98

PharmaTech

APRIL 17, 2024

Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.

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Express Pharma

JANUARY 31, 2024

Therefore, Express Pharma is launching “Regulatory Watch” a series of Master Classes led by experts and thought leaders to empower you with the knowledge and insights needed to navigate the ever-changing regulatory landscape successfully.

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Express Pharma

JANUARY 31, 2024

Therefore, Express Pharma is launching “Regulatory Watch” a series of Master Classes led by experts and thought leaders to empower you with the knowledge and insights needed to navigate the ever-changing regulatory landscape successfully.

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Express Pharma

JANUARY 31, 2024

Therefore, Express Pharma is launching “Regulatory Watch” a series of Master Classes led by experts and thought leaders to empower you with the knowledge and insights needed to navigate the ever-changing regulatory landscape successfully.

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Express Pharma

JANUARY 2, 2024

However the trickier part is weeding out the corrupt from its ranks, even while it aims to do the same with pharma companies The post Will 2024 be a year of regulatory renaissance? 2024 will thus be a year to rebuild trust in the CDSCO, with more stringent regulations, coupled with stricter implementation of these regulations.

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European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

Hospitals 91

Hospitals 91

PharmExec

APRIL 22, 2024

In this Pharmaceutical Executive video interview, Jon Hamrick, Partner, Curatio Scientia Advisors and Jon Rawlson, President & Founder, Armory Hill Advocates, discusses how they went about testing their various hypotheses for the 2023 Patient Access: State Legal and Regulatory Environment Survey and how they collected the data.

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PharmExec

FEBRUARY 6, 2024

GenAI is on the precipice of breaking new ground in regulatory intelligence; making strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

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PharmaVoice

JANUARY 8, 2024

New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

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Express Pharma

DECEMBER 13, 2023

However, regulatory focus on malignancy data might extend clinical trial timelines and increase costs for pipeline therapies, says GlobalData. Sahu adds, “The Korean regulatory agencies will now be more focussed on receiving expansive data regarding malignancies as well. There was no similar assertion in the Korean notification.

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Pharma Mirror

NOVEMBER 7, 2023

Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. Good Manufacturing Practices The post Navigating Regulatory Compliance in the Pharmaceutical Industry appeared first on Pharma Mirror Magazine.

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PharmaVoice

FEBRUARY 12, 2024

Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.

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Drug Development 147

European Pharmaceutical Review

MARCH 24, 2023

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period.

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Big Molecule Watch

FEBRUARY 1, 2024

The post Biosimilar Regulatory Updates appeared first on Big Molecule Watch. As we previously reported , Formycon’s aBLA for FYB203 was accepted for review by the FDA in August 2023.

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Biosimilars 62

Pharma Pathway

FEBRUARY 28, 2023

Executive/ Executive Job Location: MSN R&D Center, Pashamylaram, Hyderabad Core Regulatory Experience Fresher’s please do not Apply Send your Resume to : careers.r&d@msnlabs.com Ltd-Openings for Regulatory Affairs-API & Regulatory Affairs -Formulation -Apply Now MSN Laboratories Pvt.

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Pharma Marketing Network

SEPTEMBER 19, 2023

Navigating regulatory constraints in pharma advertising is essential for success in this competitive industry. Understanding Regulatory Requirements In order to comply with regulatory requirements, it is important to understand the relevant laws and regulations.

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pharmaphorum

AUGUST 1, 2023

How pharma can improve regulatory compliance with AI-based technology Mike.Hammerton Tue, 01/08/2023 - 08:00 Bookmark this

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PharmaTech

MARCH 15, 2024

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

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Pharmaceutical Technology

DECEMBER 13, 2023

Pfizer has obtained all necessary regulatory approvals for concluding the acquisition of biotechnology company Seagen for $43bn in cash.

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