MedCity News

NOVEMBER 10, 2023

In addition to safety and convenience, it is usually less expensive and just as effective as the care provided in a hospital or skilled nursing facility. If you have Original Medicare or a Medicare Advantage health plan, home health benefits are often covered at no cost – although it’s always good to check with your insurance provider.

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Pharmaceutical Technology

OCTOBER 24, 2023

The Indonesian Ministry of Food and Drug Safety approved Genexine and KGbio's Efepoetin alfa for chronic kidney disease-induced anaemia.

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PharmExec

AUGUST 4, 2022

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

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Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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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. In conclusion, it is clear US and UK regulators are working to streamline guidelines to ensure the quality and thus safety of medical devices that are made available.

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Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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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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Pharmacy Times

MAY 10, 2023

During a fireside chat, USP CEO Ronald T. Piervincenzi, PhD, and the Honorable Dr. Oh Yu-Kyoung, Minister of MFDS, Republic of Korea, discuss interruptions to the medical supply chain and the interventions used.

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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

JANUARY 29, 2024

Overall, the authors summarised that the enhanced sensitivity improves safety assessments for volatiles in medical devices. The paper discussed the detection of volatile extractables released during the clinical use of medical devices.

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Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

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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

DECEMBER 22, 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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European Pharmaceutical Review

MARCH 18, 2024

He added that the trial results could lead to this specific infusion pump delivery system to be approved by regulatory bodies such as the US Food and Drug Administration (FDA).

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PharmaTech

MARCH 14, 2023

billion to enhance food safety and advance medical product availability. FDA is seeking $7.2

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. It also achieved non-inferiority of MACE compared to ESA control, in the primary safety analysis of the ITT population.

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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). Like Stelara, the most serious known side effect of Wezlana is infection.

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European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

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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.

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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. The Data Safety Monitoring Board (DSMB) has authorised enrolment of the second dose cohort for this clinical trial in LGMD2I/R9, Atamyo noted.

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European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings. The post Sandoz granted novel biosimilars approval appeared first on European Pharmaceutical Review.

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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. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics.

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European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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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

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin.

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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

AUGUST 29, 2023

“Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” stated Dr Levi Garraway, PhD, Roche ’s Chief Medical Officer and Head of Global Product Development.

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Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

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Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

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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. It was investigated both as monotherapy and in combination with phosphate binder therapy.

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Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients.

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Food and Drug Administration FDA Food Safety 97

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. PREVNAR 20 has been designed to avert IPD caused by 20 streptococcus pneumoniae (pneumococcal) serotypes.

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European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

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Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings.

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European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . In addition, the safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported.

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Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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European Pharmaceutical Review

APRIL 25, 2023

Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months. Recent data from the ongoing Phase III trial in that enrolled 4,800 children, also show high levels of efficacy and a reassuring safety profile.

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