European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. SpringWorks Therapeutics’ Ogsiveo (nirogacestat) tablets are authorised for adults with progressing desmoid tumours who require systemic treatment.

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European Pharmaceutical Review

AUGUST 26, 2024

The European Commission has granted the first approval for a medicine to treat acanthamoeba keratitis, an ultra-rare corneal infection that can lead to blindness. Akantior was granted Orphan Drug Designation from the US Food and Drug Administration (FDA) to treat acanthamoeba keratitis.

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European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. Eisai is leading development of LEQEMBI and regulatory submissions globally.

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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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PM360

FEBRUARY 12, 2024

Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?

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European Pharmaceutical Review

SEPTEMBER 2, 2024

Three anti-hypertensive drugs combined in low doses into a single pill has been shown to be superior to standard care for lowering blood pressure in patients with uncontrolled hypertension. The oral treatment GMRx2 is biopharma George Medicines’ lead drug candidate.

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Pharmaceutical Technology

MAY 19, 2023

It received approval from the US Food and Drug Administration in October 2018. will be paid in equal quarterly instalments in 2024. 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

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

JANUARY 5, 2024

These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted. Based on the results, the clinical trial was stopped early. “We

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Pharmaceutical Technology

MAY 23, 2023

The company expects that the proceeds obtained from the deal will extend its cash runway into the fourth quarter of 2024. In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration.

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Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. But if it proves difficult, the company may be open to potentially licensing the drug, Kelleher-Andersson noted.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma.

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Pharmaceutical Technology

APRIL 20, 2023

Abdera Therapeutics president and CEO Lori Lyons-Williams stated: “Radiopharmaceuticals hold the potential to transform the treatment of cancer, but the ability to finely tune radioisotope delivery to the tumour, while sparing healthy tissue, remains a major challenge for this class of drugs.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. GA is an advanced form of age-related macular degeneration (AMD). SYFOVRE is expected to be available by the beginning of March 2023.

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Pharmaceutical Technology

APRIL 24, 2023

Such activation may lead to the onset and progression of many serious diseases. Validated through the access consortium work-sharing initiative, the marketing applications are currently under review, with approval decisions expected in the first half of 2024.

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Pharmaceutical Technology

OCTOBER 12, 2022

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death.

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European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. The Phase II clinical trial for Orano Med’s candidate AlphaMedix ( 212 Pb-DOTAMTATE) is still ongoing and top-line data are expected in mid-2024.

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. 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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European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.

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Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). While the drug is marketed in other countries, it is not registered in the US.

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European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

They will also be used for funding operating expenses and capital expenditure needs up to 2024. . Carisma president and CEO Steven Kelly will lead the combined business. On closing of the deal, the merged company will be called Carisma Therapeutics, and its headquarters will be located in Philadelphia, Pennsylvania, US.

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PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. and is one of the leading causes of kidney failure. Car T cells can help slow down aging by attacking senescent cells that multiply with age but don’t die off.

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European Pharmaceutical Review

APRIL 30, 2024

In fact, we are working with the US Food and Drug Administration (FDA) and Massachusetts Institute of Technology (MIT) on a grant where the whole emphasis is on developing a continuous mRNA vaccine manufacturing platform. Sticking to the cell and gene therapy space, what’s your main prediction for 2024?

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Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024.

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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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Pharmaceutical Technology

MAY 16, 2023

This comes with an upfront cash payment of $375 million, with a potential additional $25 million if Hemgenix net sales reach a certain milestone in 2024, based on a May 15 announcement. Hemgenix was approved by the US Food and Drug Administration (FDA) for the treatment of adult haemophilia B patients in November 2022.

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European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

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Penrod

JUNE 6, 2024

Life Sciences Cloud also drives compliance with various regulatory agencies, such as the US Food and Drug Administration. It includes Salesforce Data Cloud’s segmentation power to identify potential candidates for new trials, therapy adherence, and other insights. We’ll be updating this blog as availability changes.

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Legacy MEDSearch

JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Some countries have blocked parallel trade to prevent supplies from depleting.

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European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. Additionally, the attempt to borrow outcome measures from other diseases, which can lead to a lack of sensitivity in the measure.

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PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. The overarching theme: As with rare disease drug development, precision and personalization are key. Food & Drug Administration (FDA).

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