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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Pharmaceutical Technology

JUNE 12, 2023

The two companies announced that the Clarity AD trial met both the primary and all key secondary endpoints in September 2022. However, side effects known as amyloid-related imaging abnormalities, which often involve brain swelling, were also reported, and consequently the treatment has a warning on this specific side effect on its label.

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Medical Schools Labelling Drug Development 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

Netherlands Medicines Evaluation Board (CBG-MEB) 2022 [cited June 2022]. US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. References.

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Pharmaceutical Technology

JUNE 14, 2023

A GlobalData report which analyzes trends in new drug approvals [i] shows that small molecule approvals have now been surpassed (in 2022) by biologics. Small molecules only accounted for 41% of NME (New Molecular Entity) approvals in 2022.

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Packaging Labelling Drug Development 52

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

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Insurance Coverage and Processing Diabetes Labelling Communication 105

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.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. weight reduction in obese individuals, as per its label.

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Insurance Coverage and Processing Diabetes Labelling Communication 98

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA). In December 2022, FDORA was enacted. Among other things, it revised the provisions relating to accelerated approval at 21 U.S.C. §

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Documentation Labelling Drug Development 59

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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Packaging Documentation Labelling Communication 59

Pharmaceutical Technology

MAY 23, 2023

The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time. In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023.

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Labelling Communication Drug Development 59

Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development. Lee, Rose Purcell, and Scott J.

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Pharmaceutical Technology

APRIL 24, 2023

With early nanoparticle studies, researchers often found the human body’s innate immune response to drugs and the short-lasting effects of drugs challenging, as they can also reduce a drug’s efficacy. Since then, the drug has been used off-label in breast cancer and other types of cancer.

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Vaccines Immunity Immunization Medical Schools 59

Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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Communication Drug Development Packaging Labelling 40

Express Pharma

JANUARY 19, 2025

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. 1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. DOI: 10.1002/cpdd.1162

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Clinical Pharmacology Labelling Medical Schools Drug Development 111

pharmaphorum

SEPTEMBER 30, 2022

An open-label extension revealed that ALS patients had around six more months before being hospitalised, requiring a ventilator or dying compared to the control group and, according to Amylyx, patients who continued taking the drug survived about 10 months longer. — The ALS Association (@alsassociation) September 29, 2022.

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Specialty Pharmacies Labelling Hospitals Drug Development 98

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.

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Labelling Packaging Drug Development 121

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.

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FDA Law Blog: Biosimilars

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § Would any such failure to meet DAP goals be reflected in labeling?

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Drug Development Communication Documentation Labelling 59

PharmaShots

APRIL 3, 2023

at current exchange rates In Oct 2022, the acquisition was initiated and the transaction is expected to be adjusted per share by $0.07 greater China region & certain other countries already out-licensed by SCYNEXIS to third parties Related Post: PharmaShots' Key Highlights of Fourth Quarter 2022 events/100 patient-yrs.)

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Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Moreover, an application (NDA or BLA) based upon a surrogate or intermediate clinical endpoint seeking accelerated approval must still meet the substantial evidence of effectiveness standard and contain sufficient information to demonstrate that the drug is safe for use under the conditions of the proposed labeling.

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