European Pharmaceutical Review

JUNE 27, 2024

Looking back briefly to 2023, within the cell and gene therapy space, the US Food and Drug Administration (FDA) approved marketing authorisations for seven of these treatments. It means eligible individuals can be offered twice-yearly subcutaneous administration as alternative treatment option to intravenous administration.

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European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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European Pharmaceutical Review

MARCH 14, 2023

Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer. billion of revenue in 2023.

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Pharmaceutical Technology

JUNE 6, 2023

The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration. Alkeus Pharmaceuticals intends to submit a new drug application for gildeuretinol in 2024.

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European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In May 2024, Ocugen announced the second cohort (medium dose) completed dosing in the dose-escalation phase. What’s the latest and what’s next?

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European Pharmaceutical Review

DECEMBER 1, 2023

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease.

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Pharmaceutical Technology

JULY 31, 2024

The US Food and Drug Administration application fees have increased by around $300,000 from 2024 and by $2 million compared to a decade ago.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

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European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. The drug is also undergoing trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease.

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European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. These agreements have amassed a total deal value of $21 billion.

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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

APRIL 16, 2024

Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN). In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH).

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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

APRIL 17, 2024

The one-year data will be presented at the 2024 American Academy of Neurology (AAN) Annual Meeting. The target decision dates of mid-2024 for the European Medicines Agency (EMA) and September 2024 for the US Food and Drug Administration (FDA) regarding submission of data from the Phase III OCARINA II trial, Roche confirmed.

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Tribeca Knowledge

NOVEMBER 28, 2023

T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.

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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

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). We do not expect entry of Stelara biosimilars in the United States during 2024,” Joseph Wolk CFO, Johnson & Johnson, stated during the company’s Q3 earnings call on 18 October.

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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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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. On 9 January 2024, Eisai confirmed that LEQEMBI was approved in China to treat Alzheimer’s.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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European Pharmaceutical Review

FEBRUARY 8, 2024

Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.

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Pharmaceutical Technology

AUGUST 13, 2024

In March 2024, Madrigal Pharmaceuticals had a breakthrough moment when, after years of research and anticipation, the US Food and Drug Administration (FDA) granted approval for its Rezdiffra (resmetirom), a pioneering treatment for adults with F2-F3 metabolic dysfunction-associated steatohepatitis (MASH).

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European Pharmaceutical Review

DECEMBER 15, 2023

An approval decision by the European Commission is expected in February 2024. Casgevy was also approved by the US Food and Drug Administration (FDA) for use in patients with sickle cell disease earlier in December.

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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). Outside of the US, the European Medicines Agency (EMA) has granted VYJUVEK orphan drug designation and PRIME (PRIority MEdicines) eligibility for DEB.

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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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European Pharmaceutical Review

JANUARY 5, 2024

The Phase III STARLYNG-1 clinical study is designed to bridge to the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the US Food and Drug Administration. Based on the results, the clinical trial was stopped early. “We

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European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). The major depressive disorder treatment is expected to be available for patients in early 2024.

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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. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

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European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

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European Pharmaceutical Review

DECEMBER 13, 2024

Subsequently, Vabysmo PFS was granted first approval for the conditions by the US Food and Drug Administration (FDA) in July 2024, Roche shared. This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.

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European Pharmaceutical Review

AUGUST 26, 2024

Akantior was granted Orphan Drug Designation from the US Food and Drug Administration (FDA) to treat acanthamoeba keratitis. SIFI confirmed that the first commercial launch of the eye drops is planned in Germany in Q4 of 2024.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

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European Pharmaceutical Review

OCTOBER 23, 2024

Donanemab was approved by the US Food and Drug Administration (FDA) as Kisunla (donanemab-azbt) in July 2024. This was followed by regulatory approval in Japan in September 2024. .” Results from the TRAILBLAZER-ALZ 2 study were published in the Journal of the American Medical Association (JAMA) in July 2023.

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Pharmaceutical Technology

FEBRUARY 14, 2023

It will also support smaller dose vials development, selection of strain as per the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market.

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Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ” The final results from AGENT IDE are expected to be presented at CRT 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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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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