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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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., Are you hiring?

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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 The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations.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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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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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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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

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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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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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. FDA continues to approve the most NASs.

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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

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

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

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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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Pharmaceutical Food and Drug Administration Medicine Patients 96

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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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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pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). The post Avillion, AstraZeneca asthma rescue treatment given FDA approval appeared first on.

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Pharmaceutical Technology

MAY 30, 2023

The US Food and Drug Administration (FDA) is currently reviewing a biologic licence application (BLA) for the vaccine candidate under priority review. The FDA awarded fast track designation for VLA1553 in 2018, and breakthrough therapy designation in 2021.

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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. About Activ Surgical.

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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?

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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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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 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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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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pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

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Pharmaceutical Technology

OCTOBER 13, 2022

The news of the offer came just weeks after Myovant and its partner, Pfizer , received the US Food and Drug Administration's (FDA) expanded approval of Myfembree (estradiol + norethindrone acetate + relugolix) for the management of moderate to severe pain associated with endometriosis.

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Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. The biopharma aims to start the study as soon as the IND is cleared by the FDA.

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European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. 2018 [Cited 2022Nov]. Late-stage developments in psilocybin therapy. 2014;11(101):20140873.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8].

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Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

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World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

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World of DTC Marketing

FEBRUARY 1, 2022

The last time the SPDR ETF suffered a drop of 15% or more was in 2018, and the fund followed it up with a 33% increase in 2019. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. Bernie Sanders, I-Vt., 2wo: Crowded markets.

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World of DTC Marketing

APRIL 7, 2022

Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018. billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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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). How has the autologous T-cell immunotherapy field progressed in recent years? Medical Affairs.

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European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug. The plant is set to be operational before the end of 2023.

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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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Food and Drug Administration Medicine Food FDA 98

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Food and Drug Administration, 2023). Then, of course, there are the ethical considerations.

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