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. 3 Is two too few?

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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). Imran joined Oncology US Medical Affairs in 2018 as the Therapeutic Area Lead, Lymphoma and Myeloid Malignances.

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European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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European Pharmaceutical Review

SEPTEMBER 28, 2022

Sartans or angiotensin II receptor blockers (ARBs) are drugs indicated for the treatment of cardiovascular diseases. In 2018, one batch of the generic drug valsartan was recalled due to unacceptable levels of the nitrosamine impurity NDMA. mm × 150 mm) with a binary gradient with water as mobile phase A and 0.1 González et al.

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European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (FDA)-approved agents, GlobalData stated. Patent litigation for adalimumab resolved in the US … Mylan’s Hulio (adalimumab), launched in Europe in 2018, is currently undergoing interchangeability studies. Worldwide sales for Humira peaked at $21.2

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Trials peaked at 115 in 2018 before declining to 91 last year.

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European Pharmaceutical Review

SEPTEMBER 7, 2023

A Phase I trial employing the drug dasatinib has shown promise in clearing senescent cells in Alzheimer’s. Recent drugs targeting beta-amyloid plaques have only yielded modest results, according to the study researchers. Then no drugs were given for a period of two weeks. The cycle was repeated six times for a total of 12 weeks.

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pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. appeared first on.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. It cites convenience, ease of administration, and the resulting improved patient compliance as advantages of its transdermal system.

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. A glucosylceramide synthase (GCS) inhibitor, AL01211 has high potency, increased selectivity and other beneficial drug properties that support once-a-day oral dosing.

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European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

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European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2018; 22(5):1589-1604. 2018; 15(141):20170387. Tuijin Jishu / Propuls.

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Pharmaceutical Technology

NOVEMBER 3, 2022

Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. In prior trials, the drug was found to be well tolerated. Tourette syndrome is a serious ailment of CNS.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals.

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pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. The history of PIE. About the author.

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European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

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Legacy MEDSearch

JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Launched in February 2018, Advanced Cardiac & Vascular Centers for Amputation Prevention provides highly personalized and comprehensive cardiac, vascular, and vein care. Cardio Flow, Inc.,

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Pharmaceutical Technology

MAY 19, 2023

It received approval from the US Food and Drug Administration in October 2018. Alimera Sciences has acquired the US commercialisation rights for Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg from EyePoint Pharmaceuticals.

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

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Pharmaceutical Technology

JUNE 29, 2022

The Japanese MHLW granted initial approval for the vaccine in 2018 to prevent shingles in adults of the age 50 years and above. The US Food and Drug Administration granted approval for the vaccine in July last year to prevent shingles in at-risk adults aged 18 years or above due to immunodeficiency or immunosuppression.

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European Pharmaceutical Review

JANUARY 24, 2023

Regulatory applications for fruquintinib Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018. It was launched commercially in China in November 2018 under the brand name ELUNATE ®. This is planned to be completed in the first half of 2023.

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Pharmaceutical Technology

JANUARY 18, 2023

In June last year, Eli Lilly submitted a new drug application to the National Medical Products Administration (NMPA) of China for Galcanezumab to prevent episodic migraine in adult patients. In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults.

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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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Legacy MEDSearch

DECEMBER 6, 2022

Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021. Activ Surgical is the pioneering digital surgery company that completed the world’s first autonomous robotic surgery of soft tissue in 2018. This is a proud day in Activ Surgical’s history.”.

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European Pharmaceutical Review

JUNE 28, 2022

This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions. The drug advanced through to Phase II trials in adults living with obesity and also those with NASH in 2021. 2018 [cited 10 June 2022];93(6):1432-1441. 2021 [cited 8 June 2022].

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Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. What sets lecanemab apart from other Alzheimer’s treatments in the current drug approval space? We believe this is the reason why we were successful with this Clarity AD study.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Pharmaceutical Technology

AUGUST 16, 2022

The number of US Food and Drug Administration (FDA) injectable drug approvals for large and mega-cap pharma sponsors tends to be greater than that for small-cap (market cap <$2bn) and mid-cap (market cap $2–10bn) companies. Why do large and mega-cap sponsors outsource?

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Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. In 2020, fruquintinib received Fast Track designation from the US Food and Drug Administration (FDA) to treat metastatic CRC patients.

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Pharmaceutical Technology

APRIL 3, 2023

HUTCHMED (China) has completed the new drug application (NDA) rolling submission to the US Food and Drug Administration (FDA) for fruquintinib to treat refractory metastatic colorectal cancer (CRC).

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