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

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

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European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously.

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European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs? However, these are still investigational products.

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Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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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. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). Participant enrolment is anticipated to commence in the second half of 2023.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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European Pharmaceutical Review

OCTOBER 30, 2023

Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. Additionally, these first results were also presented at the 2023 International Limb-Girdle Muscular Dystrophy Conference. ATA-100 has received an Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

APRIL 16, 2024

In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data, Novartis confirmed.

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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European Pharmaceutical Review

JANUARY 9, 2024

Safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was found to be generally consistent with the known safety profile of each medicine. While a key secondary endpoint, favouring TALZENNA plus XTANDI was also observed, these data are immature, Pfizer noted.

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European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. XPHOZAH is expected to be available to eligible patients in the US in November 2023. It was investigated both as monotherapy and in combination with phosphate binder therapy.

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Pharmaceutical Technology

MAY 9, 2023

The US Food and Drug Administration (FDA) has granted Vedanta Biosciences’ oral microbiome treatment VE303 a fast track designation for the treatment of recurrent Clostridioides difficile (C.diff) infection, as the company plans to start a Phase III trial later this year, based on a May 8 announcement.

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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 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. This follows granting of a marketing authorisation for the antibody therapy in Japan in September 2023.

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European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto. The PSMAfore study.

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European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. In some cases, this occurred in less than 12 months, which is why fewer patients stayed on the drug for a full year.”

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European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Overall, the authors summarised that the enhanced sensitivity improves safety assessments for volatiles in medical devices.

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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

SEPTEMBER 18, 2023

The first and only treatment for anaemic patients with myelofibrosis has been approved by the US Food and Drug Administration (FDA). Phase III study SIMPLIFY-1 compared the safety and efficacy of momelotinib to ruxolitinib in patients with myelofibrosis who had not received prior treatment with a JAK inhibitor.

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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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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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Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

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Pharmaceutical Technology

MAY 3, 2023

Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares. The Center for Drug Evaluation of China’s National Medical Products Administration has also awarded a BTD to spesolimab.

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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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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). So far, 68 trials have been initiated in 2023.

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European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. These findings were presented at the 2023 Annual Meeting of the Society of Urologic Oncology (SUO).

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Pharmaceutical Technology

JULY 28, 2022

Many of the mainstay drugs for the treatment of moderate to severely active UC, such as anti-tumour necrosis factor (anti-TNF) agents like infliximab, target inflammatory mediators that are dysregulated in this condition. Data from the QUASAR induction study demonstrated positive efficacy and safety results.

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European Pharmaceutical Review

DECEMBER 5, 2022

MOMENTUM was a randomised, double-blind Phase III clinical trial of momelotinib versus danazol in symptomatic and anaemic myelofibrosis patients treated with a US Food and Drug Administration (FDA)-approved JAK inhibitor. The post EMA accepts momelotinib marketing application appeared first on European Pharmaceutical Review.

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Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. The Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). In response to the approval news, some pointed concerns about long-term safety.

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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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