European Pharmaceutical Review

FEBRUARY 17, 2023

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase.

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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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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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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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Food and Drug Administration FDA Food Safety 97

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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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

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

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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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

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 manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

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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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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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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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 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

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

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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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

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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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. billion in 2029. GlobalData is the parent company of Pharmaceutical Technology.

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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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Food and Drug Administration Pharma Manufacturing Marketing 64

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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World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 ” Ouch. Annual U.S.

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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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Food and Drug Administration Pharmacology Side effects Physicians 141

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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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

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

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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Food and Drug Administration Manufacturing Safety Transportation 85

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

Expansion has followed in 2018 with the United Kingdom, where it is experiencing an exceptional adoption rate. Food and Drug Administration (FDA) Clearance for CardioSTAT® Press Release by: Icentia Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Are you hiring?

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Food and Drug Administration Food FDA Recruitment 98

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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Food and Drug Administration Medical Patients FDA 73

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). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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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

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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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.

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