Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

FDA Approval 343

FDA Approval Clinical Trials Clinical Trials Drugs 343

Pharmaceutical Technology

FEBRUARY 2, 2023

The regulatory approval is based on the data obtained from the ASCEND-D trial, which is evaluating Jesduvroq’s safety and efficacy to treat patients. The ASCEND programme included five Phase III trials that enrolled more than 8,000 patients who received treatment for up to 4.26 dL) for the patients.

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

Pharmaceutical Technology

MAY 29, 2023

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

FDA Approval 246

FDA Approval Trials Medicine Drugs 246

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

NOVEMBER 18, 2022

Tzield was evaluated in the placebo-controlled, double-blind, randomised, event-driven TN-10 clinical trial, for delaying T1D (Stage 3, or clinical T1D) in Stage 2 T1D patients. Provention Bio stated that Tzield delayed the median onset of Stage 3 T1D by 25 months, or nearly two years, compared to a placebo in a clinical trial.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

Pharmaceutical Technology

FEBRUARY 20, 2023

The regulatory approval is based on positive data obtained from the Phase III OAKS and DERBY trials, which were conducted across a broad and representative population of GA patients. The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Trials Drugs 246

Pharmaceutical Technology

JULY 8, 2022

In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3% The trial demonstrated that after a median follow-up of 5.2 The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

FDA Approval 246

FDA Approval Medicine Trials Drugs 246

Pharmaceutical Technology

JUNE 9, 2023

Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks. Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

Bio Pharma Dive

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA Approval 327

FDA Approval Clinical Trials Clinical Trials Trials 327

Pharmaceutical Technology

SEPTEMBER 19, 2022

bluebird bio was granted a rare paediatric priority review voucher following approval. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects. “For thalassemia.

FDA Approval 246

FDA Approval In-Vivo Gene Therapy Clinical Trials 246

Pharmaceutical Technology

JULY 4, 2023

The gene therapy prevents neovascularisation from a single, intravitreally delivered injection.

FDA Approval 243

FDA Approval Gene Therapy Gene Trials 243

Bio Pharma Dive

OCTOBER 16, 2024

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

FDA Approval 254

FDA Approval Trials 254

Pharmaceutical Technology

APRIL 30, 2024

The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.

FDA Approval 246

FDA Approval Trials Drugs 246

Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

FDA Approval 246

FDA Approval Trials Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

FDA Approval 191

FDA Approval Drugs Clinical Trials Clinical Trials 191

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

FDA Approval 315

FDA Approval Drugs Trials 315

Bio Pharma Dive

JUNE 8, 2021

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it.

FDA Approval 289

FDA Approval Clinical Trials Clinical Trials Trials 289

Pharmaceutical Technology

MARCH 23, 2023

The approval from the FDA was based on the data obtained from the multiregional, open-label, single-arm POD1UM-201 trial, conducted in metastatic or recurrent locally-advanced MCC adults who did not receive systemic therapy previously for their advanced disease.

FDA Approval 245

FDA Approval Licensing Licensing Antibody 245

Pharmaceutical Technology

MARCH 13, 2023

It increased the branching of dendrites and synaptic plasticity signals in animal trials. Daybue is claimed to be the first and only drug to receive approval to treat Rett syndrome, a complex, rare neurodevelopmental disorder that affects 6,000 to 9,000 patients in the US.

FDA Approval 182

FDA Approval Trials Drugs 182

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). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

AUGUST 16, 2024

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

FDA Approval 263

FDA Approval Trials 263

Bio Pharma Dive

MARCH 30, 2021

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain.

FDA Approval 239

FDA Approval Medicine Drugs Trials 239

Pharmaceutical Technology

AUGUST 8, 2022

At week 24, both SPIRIT trials met the co-primary endpoints, with 75% of women receiving Myfembree having a clinically meaningful decline in dysmenorrhea versus 27% and 30% of women in the placebo arms, respectively. . The post US FDA approves Pfizer-Myovant’s Myfembree for endometriosis pain appeared first on Pharmaceutical Technology.

FDA Approval 189

FDA Approval Drugs Trials Marketing 189

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. 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.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

Pharmaceutical Technology

FEBRUARY 3, 2023

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. In the PATH-HOME trial, 92% of healthcare providers, patients and caregivers successfully administered Tezspire in the clinic and at home throughout the study.

FDA Approval 147

FDA Approval Antibody Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). Lilly stated that the continued approval of Jaypirca for this indication is based on clinical benefit in a confirmatory trial.

FDA Approval 147

FDA Approval Trials Drugs Development 147

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The label expansion for Cibinqo was supported by the data obtained from the placebo-controlled, randomised Phase III JADE TEEN clinical trial.

FDA Approval 147

FDA Approval Trials Clinical Trials Clinical Trials 147

Pharmaceutical Technology

APRIL 9, 2024

The Phase I/II trial will assess iadademstat in combination with immune checkpoint inhibitors in lung cancer patients.

FDA Approval 130

FDA Approval Trials 130

Pharmaceutical Technology

AUGUST 29, 2022

The approval was based on findings from the multicentre, open-label, single-arm Phase II FIGHT-203 clinical trial that assessed the safety and efficacy of Pemazyre in 28 adult patients with r/r MLNs with FGFR1 rearrangement. In the trial, the median time to response of CR was 104 days and the median duration of CR was not attained.

FDA Approval 147

FDA Approval Trials Clinical Trials Clinical Trials 147

XTalks

JANUARY 7, 2025

In addition, Traumagel, an FDA-cleared plant-based hemostatic gel , is designed to rapidly control bleeding, demonstrating the variety of solutions emerging in trauma and wound care. Symvess does carry risks, including thrombosis, graft rupture and infection.

FDA Approval 105

FDA Approval Engineer Clinical Trials Clinical Trials 105

Pharmaceutical Technology

MAY 11, 2023

The submission of sNDA was based on the data obtained from two placebo-controlled, double-blind, fixed-dose, randomised 12-week Phase III trials. The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

FDA Approval 147

FDA Approval Trials Regulation Drugs 147

World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. 78 % of all subjects were enrolled outside the U.S.

Clinical Trials 187

Clinical Trials Clinical Trials Trials Drugs 187

Pharmaceutical Technology

MAY 1, 2023

The regulatory approval is based on the data obtained from the Risperidone Subcutaneous Extended-Release Study (RISE) and the SHINE Phase III trials. Uzedy reduced the risk of schizophrenia relapse by up to 80% compared to placebo in a Phase III clinical trial.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

Pharmaceutical Technology

FEBRUARY 24, 2023

The regulatory approval is supported by the data obtained from the pivotal Phase III XTEND-1 trial. The trial evaluated the pharmacokinetics, efficacy, and safety of once-a-week ALTUVIIIO in people aged 12 years or above living with severe haemophilia A. Earlier, they received treatment with factor VIII replacement therapy.

FDA Approval 147

FDA Approval Protein Trials Drugs 147

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264