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

MAY 12, 2023

Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma. The post $1.7b

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Clarivate

SEPTEMBER 11, 2024

Timely and accurate diagnosis is critical to maximize the efficacy of available interventions – but for most individuals, the diagnostic journey remains long, complex and costly (Alzheimer’s Disease International, 2021; Chiari, 2022; Juganavar, 2023). Currently, of the eight drugs approved by the U.S. 2024; Quanterix, 2024).

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European Pharmaceutical Review

OCTOBER 19, 2023

The Investigational New Drug (IND) application for Intellia Therapeutics’ in vivo CRISPR-based candidate NTLA-2001, has been cleared as a gene editing therapy for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) in the US. This supports NTLA-2001’s potential as a single-administration therapeutic.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” The company expects to launch LODOCO for prescription use in the second half of 2023.

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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

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

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European Pharmaceutical Review

OCTOBER 30, 2023

According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. Additionally, these first results were also presented at the 2023 International Limb-Girdle Muscular Dystrophy Conference. At present, there are no curative treatments for LGMD2I/R9.

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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

SEPTEMBER 8, 2023

Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. Final guidance is scheduled to be published on 11 October 2023. The US Food and Drug Administration (FDA) first approved tirzepatide for type 2 diabetes in May 2022.

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Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

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European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. Under the terms of the deal, BMS will acquire all outstanding shares of Karuna Therapeutics common stock for $330.00

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European Pharmaceutical Review

OCTOBER 24, 2023

PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. In November 2022, the Taiwan Food and Drug Administration granted accelerated approval designation (AAD) to Nefecon.

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European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. 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 December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.

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Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

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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

MAY 15, 2023

Trial centres were located across France, Germany, and the United Kingdom with results collected during the 2022-2023 RSV season. Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023.

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European Pharmaceutical Review

AUGUST 18, 2023

“This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. FDA approves first treatment for geographic atrophy Avacincaptad Pegol Avacincaptad pegol (ACP) is a complement C5 protein inhibitor.

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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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Pharmaceutical Technology

NOVEMBER 7, 2022

A lead product candidate of the company, SNK01 is presently being analysed as a single agent and along with other agents, including checkpoint inhibitors and cell engagers, in trials to treat advanced refractory solid tumours. . “We

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European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 Ultimately, this leads to heart failure and can be fatal for male patients.

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European Pharmaceutical Review

NOVEMBER 3, 2023

UK approval of Litfulo follows Europe and US The MHRA authorisation follows approval by the European Medicines Agency (EMA) in September and by the US Food and Drug Administration (FDA) in July 2023.

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European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The 244,000 square foot facility in Devens is BMS’ third commercial cell therapy facility in the US.

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European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. US FDA granted approval of Abrysvo to Pfizer Inc.

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European Pharmaceutical Review

MARCH 6, 2023

Harwell, the UK’s leading science and innovation campus in Oxfordshire will be the location of the Moderna Innovation and Technology Centre (MITC). Construction will begin in 2023. This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022.

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Pharmaceutical Technology

APRIL 13, 2023

Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices. Projections for 2023 Digitalisation is key moving forward Fully utilising digitalisation as part of a DCT can result in savings in both time and costs.

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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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Pharmaceutical Technology

APRIL 12, 2023

In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients. Variants of these genes cause hyperactivity of the PI3Kδ pathway, preventing immune cells from maturing and functioning properly and leading to immunodeficiency and dysregulation.

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European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). This could lead to significant research waste.

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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. These innovations bestow visual inspection processes with unprecedented precision, identifying imperfections and anomalies that often elude human scrutiny.

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Pharmaceutical Technology

MAY 10, 2023

The acquisition will strengthen Sobi’s haematology medicines portfolio with the addition of CTI’s lead product Vonjo (pacritinib), a novel oral kinase inhibitor of JAK2, IRAK1 and ACRV1. Vonjo has received the US Food and Drug Administration’s approval to treat myelofibrosis in adult patients with a platelet count below 50 x109/L.

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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. SYFOVRE is expected to be available by the beginning of March 2023. GA is an advanced form of age-related macular degeneration (AMD).

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Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. The BLA submission for lifileucel, a leading drug candidate of the company, is a step toward in making TIL therapy an option for patients who have progressed following prior treatments.

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Pharma Leaders

JUNE 20, 2023

F2G has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for olorofim to treat invasive fungal infections. The NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023.

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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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