Pharmaceutical Technology

APRIL 27, 2023

Seres president and CEO Eric Shaff said: “Seres has led the development of microbiome therapeutics, and today’s FDA approval of Vowst as the first orally administered microbiota-based therapeutic for the prevention of recurrent C difficile infection marks a tremendous milestone for the patient community, and for Seres.

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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.

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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.

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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.

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Pharmaceutical Technology

MAY 23, 2023

Indivior CEO Mark Crossley said: “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids such as fentanyl. and five minutes.

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Pharmaceutical Technology

MAY 22, 2023

Continued approval for the indication is dependent on verification and description of the clinical benefit of Epkinly in confirmatory trials. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “The

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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.

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Pharmaceutical Technology

AUGUST 12, 2022

The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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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.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Pharmaceutical Technology

MAY 22, 2023

It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials.

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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.

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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.

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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.

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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.

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. For the U.S. Source link: [link]

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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.

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Pharmaceutical Technology

FEBRUARY 1, 2023

The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042. This will enable the addition of US trial sites, as well as the recruitment of eligible patients in the country to the trial.

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Pharmaceutical Technology

FEBRUARY 9, 2023

Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also for the family navigating a delicate time after preterm birth.

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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

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Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. After assessing the New Drug Application (NDA) under priority review, the FDA granted the approval based on the data obtained from a Phase II/III clinical trial.

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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.

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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.

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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.

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Pharmaceutical Technology

NOVEMBER 9, 2022

The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial. With this FDA approval, Libtayo can expand its role as a key treatment option for advanced non-small lung cancer, in addition to serving as a standard-of-care for two advanced non-melanoma skin cancers. “We

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Pharmaceutical Technology

JANUARY 12, 2023

The regulatory approval was based on the data obtained from the Phase III MANDALA and DENALI trials. Airsupra significantly reduced severe exacerbations risk compared to albuterol in moderate to severe asthma patients in the MANDALA trial.

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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.

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Pharmaceutical Technology

APRIL 18, 2023

The regulatory approval for the expanded indication was based on the data obtained from the pivotal Phase III PROGRESS trial, which assessed the efficacy, tolerability and safety of oral Qulipta 60mg once daily (QD) in adult patients with chronic migraine.

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Pharmaceutical Technology

MARCH 6, 2023

The regulatory approval was supported by the data obtained from the randomised, open-label, two cohort, multicentre, global Phase III monarchE clinical trial, which was conducted in 5,637 HR+, HER2-, node-positive EBC adult patients who are at high risk of recurrence.

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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.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

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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.

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Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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Pharmaceutical Technology

APRIL 27, 2023

The regulatory approval for the label expansion was supported by a 24-week open-label Phase III trial conducted in 75 children with CF aged between two and five years. The trial showcased the tolerance of Trikafta and indicated that its safety profile was in line with that observed in older age groups.

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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.

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

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