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. The funding will be used for the Phase III clinical trial and potential marketing of the investigational compound, ecopipam, for treating Tourette syndrome patients.

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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. With an estimated enrollment of 182 patients undergoing abdominoplasty, the company will present data comparing its transdermal system with a placebo in Q3 of 2023.

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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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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. The patient centricity movement has been building momentum in recent years. Building relevance.

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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.

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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

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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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. Affecting patient care. The AMCP backed bill (H.R. The history of PIE.

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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

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

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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Clarivate

SEPTEMBER 11, 2024

It has been shown that Aβ deposition can begin more than 20 years before symptom onset (Gordon, 2018), and that accumulation of NFT starts during the preclinical stage (Counts, 2017), when cognitive function appears normal (Anon., Currently, of the eight drugs approved by the U.S. Food and Drug Administration, 2023 and 2024).

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European Pharmaceutical Review

JANUARY 24, 2023

FRESCO-2 showed clinically meaningful improvement in overall survival in patients with metastatic CRC and was generally well tolerated. Regulatory applications for fruquintinib Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018.

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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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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). The findings showed that fruquintinib treatment reduced the risk of death by 34%.

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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. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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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. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

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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.

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Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. We look forward to utilising our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China. “We

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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. Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

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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. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

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European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

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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

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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European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

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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

APRIL 4, 2023

of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. 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.

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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. *For

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Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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European Pharmaceutical Review

JUNE 28, 2022

The approvals of empagliflozin were based on data from two pivotal, placebo controlled trials – the EMPEROR-Preserved and EMPEROR-Reduced studies, involving 5,988 and 3,730 patients, respectively. percent of patients taking placebo. Of the patients taking empagliflozin for around 23 months in the EMPEROR-Preserved trial, 13.8

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European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs kill more than 250,000 children a year, doctors warn. World Health Organization; 2006.

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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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European Pharmaceutical Review

DECEMBER 15, 2022

12 In addition, over 40 percent of patients who did not respond to between three and four conventional antidepressants within their current depressive episode continued to be managed sub‑optimally through subsequent cycles of ineffective monotherapy. Additionally, the Phase IIb trial found that outcome was associated with dose.

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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). Physically threatening and emotionally significant for patients, such exacerbations can be fatal. Commenting on the approval, Bradley E.

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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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European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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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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