European Pharmaceutical Review

JANUARY 29, 2024

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. In contrast, NDSRIs (N-Nitrosamine drug substance-related impurities) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis.

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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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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Overall, the data showed that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The regulator will announce its decision during the fourth quarter of 2023.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

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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 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

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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. Attending CPHI Barcelona 2023?

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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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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. physicians the opportunity to treat their patients with this novel device.”

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Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

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Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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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. We are working diligently with the FDA and hope to launch mirikizumab in the US as soon as possible.”

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. With an estimated enrollment of 182 patients undergoing abdominoplasty, the company will present data comparing its transdermal system with a placebo in Q3 of 2023.

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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 The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration.

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European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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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. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

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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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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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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 6, 2023

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced. Astellas to accelerate ocular disease treatments with $5.9

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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

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 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). It targets Covid-19 patients who were asymptomatic or only had mild symptoms.

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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.

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Pharmaceutical Technology

MAY 18, 2023

Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI). Pivotal trials on LMN-201 are expected to commence in 2023. It is compatible with standard-of-care antibiotics.

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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. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient.

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European Pharmaceutical Review

FEBRUARY 27, 2024

The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. It is the company ’s most advanced manufacturing facility to date.

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Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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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

Pharming Group has conducted the first commercial shipments of oral selective PI3Kδ inhibitor Joenja (leniolisib) to patients diagnosed with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in the US. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients.

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European Pharmaceutical Review

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche’s CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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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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European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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