pharmaphorum

MAY 16, 2022

The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinical trials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.

FDA Approval 115

FDA Approval Insulin Drugs Hormones 115

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The study is one of the largest DMD Phase III trials to date. million last year, of which $131.3

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

XTalks

NOVEMBER 26, 2024

The FDA’s decision follows compelling data from the ATTRibute-CM Phase III study, which enrolled 632 symptomatic patients with either wild-type or hereditary ATTR-CM. Notably, acoramidis delivered measurable benefits as early as three months into treatment, making it the most rapid response observed in Phase III trials for ATTR-CM to date.

Genetic Disease 105

Genetic Disease Genetics Protein Clinical Development 105

Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

FDA Approval 102

FDA Approval Clinical Trials Clinical Trials Trials 102

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. The Phase III VISIONARY trial enrolled 530 adults aged 18 to 65, with varying degrees of kidney function, and most were at risk of progressing to end-stage kidney disease.

Trials 101

Trials Clinical Trials Clinical Trials Antibody 101

pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.

Gene Therapy 102

Gene Therapy Gene Trials Protein 102

pharmaphorum

JUNE 1, 2022

Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on. sensitivity and 93.3%

Trials 98

Trials Clinical Trials Clinical Trials FDA Approval 98

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 96

FDA Approval Drugs Trials Development 96

pharmaphorum

JANUARY 6, 2022

PureTech is developing a modified version of the active ingredient in Esbriet (pirfenidone) that has just been shown to be less likely to cause gastrointestinal side effects than Roche’s drug in a proof-of-concept trial. The first clinical data on the drug in healthy older adults seems to back up that hypothesis.

Trials 105

Trials Marketing FDA Approval Development 105

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

pharmaphorum

OCTOBER 5, 2020

While there are several immunotherapies in development for mesothelioma the Opdivo and Yervoy combination is the first to win FDA approval in this stage of the disease, based on findings of the CheckMate-743 trial.

FDA Approval 59

FDA Approval Trials Clinical Development Development 59

Outsourcing Pharma

JUNE 22, 2022

The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.

FDA Approval 98

FDA Approval Production Trials Clinical Development 98

Pharmaceutical Technology

JUNE 7, 2023

In 2017, the therapy received FDA approval for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The trial’s main objective was to assess the efficacy of letermovir against valganciclovir (VGCV).

FDA Approval 130

FDA Approval Clinical Development Drugs Medicine 130

Outsourcing Pharma

NOVEMBER 19, 2020

The control arm, engineered from historical trial data derived from more than 22,000 previous studies, will be used in a Phase III cancer trial.

FDA Approval 54

FDA Approval Trials Engineer Clinical Development 54

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 78

FDA Approval Drugs Trials Development 78

Delveinsight

SEPTEMBER 9, 2021

For each component, Adaptimmune has agreed to supervise clinical candidates development by using its induced pluripotent stem cell (iPSC) derived allogeneic platform for production of T-cells (iT cells). TransMedics receives FDA approval for its OCS heart system. Owlstone Medical raises USD 58 Million in Series D round.

FDA Approval 73

FDA Approval Development Research Production 73

The Pharma Data

AUGUST 24, 2020

In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

Gene Therapy 52

Gene Therapy Gene FDA Approval Trials 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinical trials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%

Development 147

Development Drugs Clinical Trials Clinical Trials 147

pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. MindMed has a combination of the MDMA and LSD in a phase 1 clinical trial scheduled to start this year, to see if the drugs can be used to aid a psychedelic-assisted therapy session.

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). Initial testing is planned for late 2024 through early 2026, with further preclinical and Phase I trials depending on additional funding.

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccine Vaccination Development 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

pharmaphorum

FEBRUARY 21, 2022

One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Clinical trial diversity improved during COVID-19 (but not enough) .

Clinical Research 111

Clinical Research Research Clinical Trials Clinical Trials 111

pharmaphorum

JULY 25, 2022

Shares in VistaGen Therapeutics have plummeted after the company reported that its lead pherine nasal spray candidate failed the first of two phase 3 trials in social anxiety disorder (SAD), placing the future of the programme in doubt. The company is now firmly in penny share territory at $0.15, down from a 52-week high of more than $3.25.

Clinical Trials 59

Clinical Trials Clinical Trials Trials FDA Approval 59

Pharmaceutical Technology

MARCH 1, 2023

While the pandemic dramatically increased public awareness of mRNA therapeutics, lesser-known categories of RNA-based therapies have been established and approved for use by the FDA for almost a decade. RNA-based drug development warrants close monitoring as more RNA drug assets enter late-stage clinical trials.

RNA 147

RNA Vaccine Vaccination Genetics 147

pharmaphorum

MARCH 10, 2021

With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. .

Clinical Trials 94

Clinical Trials Clinical Trials Trials Drugs 94

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). percent and the risk of developing severe RSV-associated LRTD by 94.1

Vaccine 105

Vaccine Vaccination FDA Approval Development 105

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Production RNA Medicine 52

pharmaphorum

JANUARY 5, 2022

Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a vaccine for shingles based on the same technology platform through clinical development, with trials due to start later this year.

Vaccine 105

Vaccine Vaccination Sales Clinical Development 105

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials 52

Trials Clinical Trials Clinical Trials Research 52

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

Delveinsight

JULY 20, 2021

QUEST is a 180-subject, randomized, double-blinded, active sham-controlled clinical trial that is being conducted under an investigational device exemption (IDE). for the clinical development and commercialization of infectious disease molecular diagnostic products. On July 01, 2021, Seegene Inc.,

FDA Approval 96

FDA Approval Marketing Trials Gene 96

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

FDA Approval 40

FDA Approval HR Vaccine Vaccination 40

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Recombinant DNA Technology 100

Recombinant DNA Technology Production Antibody FDA Approval 100