2019, 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 ). 314.150(c).

Documentation

Documentation Labelling Drug Development

FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

JANUARY 16, 2023

The drug is administered via intramuscular injection and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology. In 2019, there were 40 million individuals with bipolar disorder worldwide. It plans to launch the drug in more countries and regions around the world.

Labelling

Labelling Drug Development

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

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.

Labelling

Labelling 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

The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. 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. February 2019.

Labelling

Labelling Drug Development

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

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. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

Drug Development

Drug Development Documentation Labelling Medical Records

PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

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.

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

Tackling multimorbidity through collaboration

pharmaphorum

AUGUST 5, 2020

“Secondly, this single-disease focus leads to polypharmacy, and we still don’t understand all of the drug-to-drug interactions that this older multimorbid patient will be experiencing and the impact on their health. Porkess adds that there are many other challenges in researching drugs that take into account multiple conditions.

Hospitals

Hospitals Labelling Diabetes Drug Development

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% 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. compared to a 5.1%

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% 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. compared to a 5.1%

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

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. 2019; 83(1):169-178. Oncotarget.

Chemotherapy

Chemotherapy Dosage Labelling Compounding

Drug Repurposing: Unlocking access to rare solutions

Express Pharma

NOVEMBER 1, 2024

In the marathon of drug development, where billions of dollars and over a decade of research are the norm, drug repurposing is quietly reshaping the landscape. Challenges in drug repurposing Despite these technological and regulatory advancements, the journey of drug repurposing is not without its challenges.

Drug Development

Drug Development Compounding Generic Medicine Vaccines

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

Top 20 Radiopharma Companies Based on Market Cap

PharmaShots

FEBRUARY 21, 2023

Market Cap: $10.67M Founded Year: 2009 Total Employees: ~410 Headquarters: Colorado, United States Stock Exchange: OTCMKTS Clovis Oncology is a biopharma company that develops and delivers anti-cancer agents to the US, EU, and other international markets.

Dosage

Dosage Labelling Immunity Immunization

PharmaShots' Key Highlights of First Quarter 2023

PharmaShots

APRIL 3, 2023

The system offers alternative options for those patients receiving other medications The system was originally approved in 2019 for treating chronic pain. vs 10%) The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl.

Pharmacist Digest

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

FDA approves long-acting injectable for schizophrenia and bipolar disorder

Trending Sources

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

Newron says pivotal treatment-resistant schizophrenia trial is a go

The Caregiver Vertical: How Pharma Engages

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

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

Tackling multimorbidity through collaboration

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

Novel oral chemotherapeutic holds potential for stomach cancer patients

Drug Repurposing: Unlocking access to rare solutions

Shining a light on Raman for microbiological analysis

Top 20 Radiopharma Companies Based on Market Cap

PharmaShots' Key Highlights of First Quarter 2023

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