LifeProNow

FEBRUARY 2, 2025

This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management.

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Express Pharma

DECEMBER 2, 2024

The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. Novo Nordisk is leading the pack with four separate products, two apiece in Phase III and Phase II.

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Labelling Diabetes Drug Development 126

PharmExec

NOVEMBER 20, 2024

Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.

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Labelling Drug Development 52

Drug Patent Watch

MARCH 12, 2025

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? It's not just a matter of copying a formula and slapping a new label on it. Share your thoughts in the comments below!

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Packaging Labelling Drug Development 97

Pharmaceutical Technology

OCTOBER 19, 2023

Adcetris/AVD is already approved as a first-line treatment for patients with CD30+ Stage IV Hodgkin lymphoma.

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Labelling Drug Development 105

European Pharmaceutical Review

JANUARY 16, 2023

It plans to launch the drug in more countries and regions around the world. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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Labelling Drug Development 122

Pharmaceutical Technology

MARCH 29, 2024

Its label was expanded in 2022 for use in patients 12 years and older. Vemlidy was first approved to treat adults with HBV in 2016.

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Labelling Drug Development 52

Pharmaceutical Technology

NOVEMBER 24, 2022

We talked to Iain Shaw, Senior Director of 14 C Enabled Drug Development, and Eleanor Row, Executive Director of Commercial, at Quotient Sciences, a drug development and manufacturing accelerator. How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

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Labelling Drug Development Packaging 52

pharmaphorum

AUGUST 18, 2021

The accelerated approval means GSK’s drug has a broader label in dMMR tumours than both Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab), which so far are approved for dMMR-positive colorectal cancer only. billion takeover of Tesaro in 2019.

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Labelling Drug Development 52

FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial.

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Drug Development Labelling 69

Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .

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Labelling Communication Drug Development 128

FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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Labelling Biosimilars Drug Pricing Dosage 104

Express Pharma

JULY 1, 2024

Momna Ali, Healthcare Analyst at GlobalData, states, “Amylyx’s acquisition of avexitide marks its entry into the drug development field for metabolic diseases, a departure from its prior focus on neurodegenerative diseases. This shift in strategy comes after Relyvrio’s disappointing efficacy results from the drug’s confirmatory trial.

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Labelling Diabetes Drug Development 104

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. ” The new data could accelerate partnering efforts of the drug this year.

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Labelling Drug Development 105

Pharmaceutical Technology

MARCH 2, 2023

SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease. There are three more drug candidates with major trial readouts that are expected in 2023. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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Labelling Drug Development 105

European Pharmaceutical Review

SEPTEMBER 26, 2023

Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm. In terms of drug development , the company stated that filing for marketing approval of the oral small molecule treatment in the EU, Switzerland and UK is planned for Q1 2024.

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Labelling Drug Development 110

European Pharmaceutical Review

FEBRUARY 7, 2023

RMAT designation will provide the benefits of added intensive FDA guidance and expedited review through the programme’s development. RMAT designation RMAT designation is designed to expedite the drug development and review processes for promising pipeline products, including gene therapies.

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Labelling Drug Development 105

pharmaphorum

MARCH 23, 2021

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study.

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Labelling Drug Development 98

Drug Patent Watch

DECEMBER 12, 2024

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Express Pharma

MAY 22, 2023

The addition of India to this important study will help to accelerate the development of this drug,” said Mickey Mikitani, Co-CEO, Rakuten Medical. ASP-1929 is a conjugation of antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform.

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Labelling Drug Development 98

European Pharmaceutical Review

OCTOBER 4, 2022

The electrochemistry-based technique, recorded in the journal Analytical Chemistry , actively monitors the efficacy and safety of therapeutic protein components throughout the drug development process.

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Labelling Drug Development 103

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Biosimilars Packaging Labelling Drug Development 130

FDA Law Blog: Biosimilars

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”). Tobolowsky & David B.

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Labelling Drug Development 40

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Clinical trial packaging and labelling solutions. Trends in clinical packaging.

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pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. To be clear, there will always be challenges in drug development, and stakeholders are no stranger to this.

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Insurance Coverage and Processing Drug Development Documentation Labelling 89

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 97

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Additional concerns for the caregiver include a strain on physical and mental health.

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Labelling Drug Development 98

pharmaphorum

JULY 22, 2021

The green light for Pemazyre (pemigatinib) has been hailed by cholangiocarcinoma charity AMMF, which said it was a “major milestone” in the fight against the “Cinderella” cancer, which for years has been overlooked by drug developers.

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Chemotherapy Labelling Drug Development 59

Pharmaceutical Technology

JULY 28, 2022

The current standards of care (SOCs) in OA focus on symptom management and are made up of generic pharmaceuticals, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, antidepressants and intra-articular (IA) injections. There are no disease-modifying drugs currently approved for OA.

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Labelling Drug Development 52

Pharmaceutical Technology

JANUARY 23, 2023

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. The Role of Master Protocols in Pediatric Drug Development. This lack of options and progression within this IBD patient subpopulation presents a clear unmet need and opportunity.

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FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Drug Development Documentation Labelling Medical Records 64

Pharmaceutical Technology

SEPTEMBER 15, 2022

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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Packaging Labelling Pharmaceutical Manufacturing Documentation 40

Pharmaceutical Technology

JUNE 14, 2023

The increase in demand for CPO services today and over the last decade is evidence of the added value that they offer to pharma companies both large and small, especially as drug developers seek to claim their share of the evolving ATMP market while overcoming complex challenges in its supply chain.

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Packaging Labelling Drug Development 52

pharmaphorum

DECEMBER 5, 2022

Dr Shreeram Aradhye, president of global drug development and CMO at Novartis, said: “We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis.”.

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Chemotherapy Labelling Compounding Drug Development 59

FDA Law Blog: Biosimilars

MARCH 26, 2024

Beyond the unmet medical needs that Duvyzat helps to address, we see this approval to be notable from a drug development and regulatory perspective. The primary basis for approval, like other drugs for DMD, was based on a single placebo-controlled randomized trial.

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