Pharmaceutical Technology

OCTOBER 12, 2022

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

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XTalks

OCTOBER 18, 2024

Additionally, the FDA approved FoundationOne Liquid CDx as a companion diagnostic, enabling early detection of PIK3CA mutations through a routine blood test to help identify patients most likely to benefit from Itovebi. Why Target PIK3CA Mutations?

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Pharmaceutical Technology

DECEMBER 5, 2022

However, the lack of in-person administration by physicians will likely also impact patient compliance. Overall, Aurinia’s Lupkynis is expected to face tough competition from Benlysta in LN, which received FDA approval in December 2020 and EMA approval in May 2021.

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Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally.

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pharmaphorum

SEPTEMBER 1, 2021

One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem. The FDA approval is based on data showing it is as effective as Invega Trinza formulation, keeping 92.5%

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pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. The drug is already approved for this indication in dozens of other countries around the world, including much of Europe, Australia and New Zealand.

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XTalks

JULY 3, 2023

How Can Suflave Boost Patient Compliance? With the introduction of Suflave, a low-volume, lemon-lime-flavored colonoscopy preparation, Sabela Pharmaceuticals aims to overcome these hurdles and boost patient compliance. Sabela Pharmaceuticals says the product will be available by prescription starting in August.

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XTalks

JUNE 12, 2023

The manufacturing process for cell therapies, like autologous T cell therapy, is complex and labor-intensive, involving numerous procedures that can affect regulatory compliance and consistency. In recent years, several cell therapy manufacturing facilities in the US have garnered FDA approval.

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XTalks

MAY 19, 2022

Mitsubishi Tanabe Pharma America last week announced US Food and Drug Administration (FDA) approval of RADICAVA ORS® (edaravone), a medication for patients with amyotrophic lateral sclerosis (ALS). While several of these candidates are in the discovery/pre-clinical phases, a few are moving closer toward the FDA approval process.

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Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients. Ken Phelps.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

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FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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Pharmaceutical Technology

OCTOBER 5, 2022

The US government has recently prioritized the pursuit of cases such as Biogen’s as a warning to the industry to remain in compliance of the law. “I At the same time, companies need to prioritize their compliance programs. The $900 million dollar settlement was previously announced in June but has only been finalized this month.

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FDA Law Blog

NOVEMBER 30, 2022

The purpose of the PAI was to determine whether the facility has a quality system that was designed to achieve sufficient control over the facility and commercial manufacturing operations and evaluate the facility’s Good Manufacturing Practice (GMP) compliance. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. RELATED: GLP-1 Agonists for Diabetes: Mounjaro Versus Ozempic Why is There a Semaglutide Shortage?

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Camargo

OCTOBER 14, 2020

In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device. Senior Director of Regulatory Compliance and Submissions.

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Pharma Marketing Network

MARCH 3, 2025

However, balancing effective targeting, regulatory compliance, and patient trust can be a challenge. The key is precision, personalization, and compliance. However, pharma marketers must navigate strict compliance regulations to avoid misleading advertising or privacy violations. Ensure your ads are responsive and load quickly.

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Pharma Marketing Network

MARCH 3, 2025

However, balancing effective targeting, regulatory compliance, and patient trust can be a challenge. The key is precision, personalization, and compliance. However, pharma marketers must navigate strict compliance regulations to avoid misleading advertising or privacy violations. Ensure your ads are responsive and load quickly.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products. The med spa has agreed to this requirement.

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Pharma Marketing Network

MARCH 3, 2025

This guide explores programmatic advertising best practices , helping pharma marketers refine their strategies, optimize ad spend, and maintain regulatory compliance. Geo-Targeting for Regulatory Compliance Different regions have different regulations for pharmaceutical advertising. For example, a drug approved by the FDA in the U.S.

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Camargo

NOVEMBER 15, 2021

Proposals for novel excipients that have not been previously used in an FDA-approved drug product, and do not have an established use in food, are being accepted through December 7, 2021, for the first stage of review. Manager, Regulatory Compliance. Co-Authors: Bill Stoltman, JD. Vice President, Regulatory Operations.

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ACRP blog

SEPTEMBER 4, 2024

Food and Drug Administration (FDA) approval, while common reasons for trial failure include poor patient selection, recruitment challenges, and complex study designs.{1} Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky.

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). The Figurate automation platform provides a central data repository, enabling process analytics, reporting, and regulatory compliance.

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Pharma Marketing Network

JANUARY 7, 2025

Table of Contents Sr# Headings 1 Introduction: The Importance of Marketing in Pharma 2 Digital Strategies Redefining Pharma Marketing 3 Building Trust Through Patient-Centric Campaigns 4 Navigating Compliance While Innovating Introduction: The Importance of Marketing in Pharma Marketing in pharma has never been more critical.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Say you’re in the midst of securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved. Probably not.

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XTalks

APRIL 21, 2023

And in 2015 the US Food & Drug Administration (FDA) approved an assay on Theranos’ proprietary technology.” It highlights the importance of ethical standards, due diligence and regulatory compliance, and underscores the potential risks associated with over-hyped or fraudulent startups.

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Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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Advarra

JULY 27, 2022

The document also captures how a product will be managed during the commercial phase of the lifecycle, including relevant post-approval CMC commitments and PACMPs. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. Go-to-market Strategy.

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Advarra

JULY 26, 2022

Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. With the exception of one highly purified form of CBD (Epidiolex), no other CBD products are currently FDA approved.

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pharmaphorum

DECEMBER 22, 2022

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance.

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Delveinsight

NOVEMBER 26, 2020

Fortunately, there are FDA-approved products present in the Retinal vision occlusion drug market including Lucentis (ranibizumab), Eylea (aflibercept), and Ozurdex (dexamethasone intravitreal implant) with Avastin in use as an off-label therapy to help manage the condition and improve the vision.

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FDA Law Blog

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

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FDA Law Blog

MAY 3, 2021

While these areas have been the subject of increased enforcement activity because of the national opioid epidemic, DEA registrants should not forget that at the local level compliance with the Controlled Substances Act (“CSA”) and DEA regulatory requirements on recordkeeping, reporting and security remain an Agency priority.

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XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

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XTalks

APRIL 25, 2024

This method preserves the intra-atrial septum for future interventions and potentially offers better accommodation of volume and pressure changes due to the compliance of the coronary sinus. The Barostim NEO System received FDA approval in 2019 for use in specific HFrEF patients who have exhausted other treatment options.

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