FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.” Based on this data set, RWD/RWE were identified by FDA as being used in a trivial 0.34

Medical Records 111

Medical Records Documentation 111

Express Pharma

JUNE 26, 2023

Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. To address this need, Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. This creates a strong need to ensure evidence-based safety and efficacy.

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Labelling Compounding 119

Quality Matters

MARCH 8, 2024

Navigating “Trending” Supplements Last year, we witnessed growing interest in consumer health and wellness products that were trending on social media. For some products – like dietary supplements – an impulse buy can be dangerous. For some products – like dietary supplements – an impulse buy can be dangerous.

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Labelling 98

Eye on FDA

NOVEMBER 9, 2023

The first letter posted this week was issued on October 31 and was in sole relation to a direct-to-consumer brochure that contained promotional claims for an on demand contraceptive. In it, language was used to assign a specific percentage in relation to the product’s efficacy. But there has been one trend worth noting.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies 88

LifeProNow

MARCH 17, 2023

Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP). Copenhagen’s moist snuff smokeless tobacco product is a pre-existing tobacco product that has been marketed in the U.S. for years without modified risk information.

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Labelling 100

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

FDA Law Blog: Biosimilars

DECEMBER 12, 2023

The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food. Upper bound of 95% CI ≤ 2.5

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Labelling 59

pharmaphorum

MARCH 25, 2022

In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. The FDA views wellness apps as akin to over-the-counter homeopathic treatments—products with minimal risks and low potency – and they are unregulated. Consistent Standards Matter.

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pharmaphorum

SEPTEMBER 30, 2021

There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken. The post FDA posts guidance on mining real-world data from health records appeared first on.

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Documentation 81

FDA Law Blog: Biosimilars

JUNE 28, 2023

This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.

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Labelling 45

pharmaphorum

JANUARY 22, 2021

In this article, we focus in particular on how COVID-19 may be changing prescribing decisions using market research and claims data. For example, prescribing more established therapies or therapies with more robust efficacy and safety data may make it easier for HCPs to titrate dosing or manage adverse events.

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Specialty Pharmacies Pharmaceutical Companies Pharmaceutical Companies Vaccines 98

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. It was granted based on data from the Phase III study, which demonstrated that the vaccine induced neutralising antibodies against the SARS-CoV-2 original strain.

Vaccines 119

Vaccines 119

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. It is estimated that around 40% of patients with cirrhosis accompanied by fluid build-up in the abdomen will develop HRS during the natural history of their disease.

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Packaging Labelling 93

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management. The 510(k) summaries also include details on the planned modification protocols, including an impact assessment to address requirements for data management.

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Labelling Communication 115

European Pharmaceutical Review

MARCH 28, 2023

Data technologies will include advanced data collection and analysis systems to ensure product and data quality. Ultimately, this will help with productivity and process performance to help deliver quality medicines. Eli Lilly claimed that based on current design estimates, Limerick is estimated to produce 3.17

Pharmaceutical Companies 71

Pharmaceutical Companies Pharmaceutical Companies 71

Pharmaceutical Business Review

JANUARY 7, 2024

The agreement grants Maruho exclusive rights to commercialise the product in Japan for all indications treated by the product. Nitric oxide is a signalling molecule claimed to control vasodilation and inflammation. AOB will be responsible for supplying B244 to Maruho.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. District Court challenging FDA’s plan to remove their products from the market. Phibro Animal Health Corp. has filed suit in the D.C. In its whopping 70-page complaint.

Communication 59

Communication 59

Pharmaceutical Technology

SEPTEMBER 7, 2022

A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals. The vaccine was assessed in Phase I, II and III clinical trials with successful data.

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Vaccines 105

European Pharmaceutical Review

MAY 3, 2023

For instance, digital biomanufacturing, also known as digital bioprocessing, has become promising in helping to improve process robustness and drug product quality. Examples include process analytical technologies (PAT), data analysis software (DAS), manufacturing execution systems (MES) and digital twins. In bioprocessing 4.0,

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Compounding 90

Drug Channels

DECEMBER 5, 2021

Better Data, Better Outcomes: A LexisNexis ® Risk Solutions and Q1 Productions Webinar. Your business depends on the data collected everyday across healthcare. That data not only drives the validation of the products and services your company offers today, but it also generates opportunities for new products and services.

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pharmaphorum

JUNE 22, 2022

Pfizer has harnessed the expertise of health data specialist Truveta to provide close monitoring of safety and other signals for its products, including COVID-19 vaccine Comirnaty, almost in real-time. “We hope to continue to find additional benefit from this growing data such as identifying and addressing health disparities.”

Medical Records 101

Medical Records Vaccines 101

Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). Qdenga is claimed to be the only dengue vaccine approved in the UK to prevent dengue fever, regardless of previous exposure.

Vaccines 105

Vaccines Immunity Immunization 105

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products.

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Labelling Packaging Communication Pharmaceutical Companies 52

pharmaphorum

NOVEMBER 30, 2020

UK artificial intelligence startup Okra Technologies has launched a new software platform that it claims can take the guesswork out of the price that can be charged for new drugs, years ahead of launch. The AI was built using data from more than 1,700 drugs that have been launched in Europe, creating a virtual model for HTA negotiations.

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Drug Pricing Communication 64

Pharma in Brief

JUNE 14, 2022

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure.

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Pharmaceutical Technology

JULY 15, 2022

Yet, data transparency must be foregrounded to foster patient trust, or AI’s potential in fertility treatments will not be realised. This is born out in the data. Fairtility also claims the product reduces the time taken for each IVF cycle by 30 hours. Data transparency is essential for cultivating a culture of trust.

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Pharmaceutical Technology

MAY 1, 2023

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

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Packaging 64

European Pharmaceutical Review

MARCH 27, 2024

Data from SwedenBIO’s 2023 Pipeline report shows that drug development companies with Swedish headquarters (excl. Given the strong focus on precision medicine, we also need to measure the development of companion diagnostics and other tools and technologies accompanying the drug development and production.”

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Drug Development 83

Pharmaceutical Technology

MARCH 31, 2023

The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually.

Vaccines 105

Vaccines 105

Safe Biologics

JANUARY 12, 2024

Participants discussed how the price-setting policy will result in fewer drugs being developed, reduced patient access to these medicines, and will likely fail to control costs as its proponents claim. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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Biosimilars Drug Pricing 130

Pharmaceutical Technology

MAY 11, 2023

It is claimed to be the first and only IDH1-targeted therapy to receive approval in Europe. This regulatory approval for Tibsovo to treat cholangiocarcinoma was supported by the data obtained from the ClarIDHy Phase III trial. Findings showed that the median progression-free survival (PFS) for Tibsovo was 2.7

Chemotherapy 52

Chemotherapy 52

Pharmaceutical Technology

MAY 8, 2023

The China National Medical Products Administration (NMPA) has granted approval for BeiGene’s four applications for Brukinsa (zanubrutinib). The latest regulatory approvals from NMPA to treat CLL/SLL are supported by data from SEQUOIA, which was conducted in previously untreated CLL/SLL patients.

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PharmaShots

MAY 15, 2023

In just a few years, the Kalderos platform has had a major impact on the industry, with more than 4,250 CEs onboarded, 850,000 Medicaid and commercial claims reviewed, $675 million in noncompliance identified, and CEs in all 50 states responding to inquiries.

Drug Pricing 40

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

PharmaState Academy

FEBRUARY 29, 2024

CASE STUDY Seizing Opportunities Launching a Revolutionary Pharmaceutical Product Across Diverse Tier 2 Cities Table of Contents Case Study Introduction: Introduction to the case study focusing on launching a new pharmaceutical product in multiple Tier 2 cities in India. Let us gain more insights into the case study!

Health and Personal Care Stores 52

Health and Personal Care Stores Hospitals Communication Customer Service 52

pharmaphorum

JANUARY 11, 2023

Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. Data generation and chess.

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Compounding Drug Development 121

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products.

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Labelling Packaging Communication Pharmaceutical Companies 40

Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. After assessing the New Drug Application (NDA) under priority review, the FDA granted the approval based on the data obtained from a Phase II/III clinical trial.

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Dosage 52