European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. AI and future perspectives: a glimpse into tomorrow Figure 2: adapted from Saha, G.

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European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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European Pharmaceutical Review

FEBRUARY 22, 2024

A report by Towards Healthcare has forecasted that the advanced drug delivery market will value $375.86 The year 2023 was “significant” for the progress of advanced drug delivery systems, the author reflected. A key innovation method is the oral route of administration. billion by 2033. Last year, with a size of $234.84

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Approximately 40 million people in the US experience Type I allergic reactions due to food, venom or insect stings, 4 and the numbers are similar in Europe. What are the main advantages of EURneffy over similar treatments?

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Pharmaceutical Technology

JUNE 5, 2023

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Pharmaceutical Technology

NOVEMBER 28, 2024

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months.

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European Pharmaceutical Review

MAY 7, 2024

A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6 Injectable drugs are adopted widely as treatments for chronic infections such as HIV/AIDS and tuberculosis (TB). This has resulted in more access to injectable drugs. Teva Pharmaceuticals Industries Ltd.,

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European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

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World of DTC Marketing

SEPTEMBER 7, 2022

Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it.

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European Pharmaceutical Review

FEBRUARY 5, 2024

Incentivising small molecule drug innovation According to the Biotechnology Innovation Organization (BIO), the bipartisan Ensuring Pathways to Innovative Cures ( EPIC Act ) passed last week in the US, is a “critical” step for incentivising small molecule drug innovation.

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European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

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Pharmaceutical Technology

AUGUST 8, 2024

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

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Pharmaceutical Technology

NOVEMBER 18, 2024

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

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Pharmaceutical Technology

NOVEMBER 1, 2024

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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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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European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The post FDA publishes paper on AI/ML in drug development appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

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European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. Supporting clinical development in the pharmaceutical industry NIH funding for clinical trials represented <3.5 million per approved drug. This was ~10 percent of reported industry spending.

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European Pharmaceutical Review

OCTOBER 9, 2022

QBiotics, a biotech firm in Australia, initially identified tigilanol tiglate as potentially useful for drug development. To develop the drug, researchers used a Chinese herbal medicine called Croton tiglium (purging croton), which has an active pharmaceutical ingredient (API) called phorbol.

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European Pharmaceutical Review

MARCH 27, 2024

Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.

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Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

JUNE 3, 2024

Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).

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Pharmaceutical Technology

JANUARY 17, 2024

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

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Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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Pharmaceutical Technology

SEPTEMBER 13, 2024

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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Pharmaceutical Technology

SEPTEMBER 16, 2024

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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Pharmaceutical Technology

APRIL 29, 2024

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

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