2017, Drug Development and Labelling

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

APRIL 8, 2025

Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

Documentation

Documentation Labelling Drug Development

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

JUNE 26, 2025

This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025. 7 Gabriella M. McLoughlin et al., 10 Julie A. 117–169, 136 Stat.

Drug Pricing

Drug Pricing Communication Drug Development Documentation

FDA takes major step to ease access to CAR-T therapy

BioPharma Dive

JUNE 27, 2025

Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market.

Drug Pricing

Drug Pricing Hospitals Immunity Immunization

Smarter learning and better outcomes: How AI can provide an advantage in medical education

pharmaphorum

AUGUST 14, 2025

Skip to main content Thursday 14 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Labelling

Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

JULY 2, 2025

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Drug Development

Newron says pivotal treatment-resistant schizophrenia trial is a go

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.

Labelling

Labelling Drug Development

Roche stops dosing in trial of Huntington’s disease hopeful tominersen

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. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis.

Labelling

Labelling Drug Development

The Caregiver Vertical: How Pharma Engages

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. February 2019.

Labelling

Labelling Drug Development

Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

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. Mirikizumab has lost significant ground in the anti-IL23 drug class to AbbVie’s Skyrizi, and to a lesser extent Janssen’s Tremfya. Ther Innov Regul Sci.

Labelling

Labelling Compounding Drug Development

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. The worldwide trend of using botanical drugs and strategies for developing global drugs.

Drug Development

Drug Development Documentation Labelling Biosimilars

GSK turns to AI specialist Tempus for R&D productivity boost

pharmaphorum

OCTOBER 18, 2022

Its aim is for patients to benefit from the treatment of others who came before, by providing data tools to drug developers and healthcare professionals. The two companies have been working together for some time.

Labelling

Labelling Drug Development

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. weight reduction in obese individuals, as per its label. The same can be said for the US.

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. weight reduction in obese individuals, as per its label. The same can be said for the US.

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B.

Compounding

Compounding Dosage Labelling Drug Development

Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. 2017; 8(23):38022-38043. Oncotarget.

Chemotherapy

Chemotherapy Dosage Labelling Compounding

Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

pharmaphorum

SEPTEMBER 30, 2022

The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017. An oral version of edaravone was cleared this year. Bad news for Biohaven.

Specialty Pharmacies

Specialty Pharmacies Labelling Hospitals Drug Development

Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

FEBRUARY 23, 2023

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

Labelling

Labelling Packaging Drug Development

Pharmacist Digest

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Trending Sources

FDA takes major step to ease access to CAR-T therapy

Smarter learning and better outcomes: How AI can provide an advantage in medical education

Why security-first design is the fix to stalling AI pilot tools

Newron says pivotal treatment-resistant schizophrenia trial is a go

Roche stops dosing in trial of Huntington’s disease hopeful tominersen

The Caregiver Vertical: How Pharma Engages

Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Botanical drugs – what is the best way forward for regulatory and market approval?

GSK turns to AI specialist Tempus for R&D productivity boost

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

Novel oral chemotherapeutic holds potential for stomach cancer patients

Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

Shining a light on Raman for microbiological analysis

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