XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. Biohaven’s Nurtec ODT is the first and only FDA-approved CGRP receptor antagonist available in a quick-dissolve ODT formulation.

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Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES. Novaliq’s CyclASol (0.1%

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Drug Discovery World

NOVEMBER 24, 2022

The drug is approved for the treatment of adults with haemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage or have repeated, serious spontaneous bleeding episodes. . A unique approach. at 24 months post infusion.

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Gene Therapy FDA Approval Gene Clinical Trials 52

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 76

FDA Approval Drugs Trials Development 76

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 102

FDA Approval Insulin Drugs Hormones 102

Pharmaceutical Technology

NOVEMBER 30, 2022

This is the first approval for Biktarvy in paediatric indication in the EU and applies to all 27 EU member states, Liechtenstein, Norway and Iceland. The latest development is based on data obtained from an open-label clinical trial of Biktarvy.

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Marketing FDA Approval Clinical Trials Clinical Trials 246

XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. The data showed a 98.9

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FDA Approval Vaccination Vaccine In-Vitro 59

Drug Discovery World

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). The post FDA approves gene therapy for rare neurological disorder appeared first on Drug Discovery World (DDW).

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Gene Therapy FDA Approval Gene Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. 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.

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Clinical Development Vaccination Vaccine Development 52

Outsourcing Pharma

SEPTEMBER 30, 2020

The companyâs Phase II trial of ultramicronized PEA has received FDA approval and expects to begin dosing patientparticipants as early as next month.

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Trials FDA Approval Clinical Development Development 118

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 101

FDA Approval Clinical Trials Clinical Trials Trials 101

pharmaphorum

OCTOBER 5, 2020

The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab), as the first and only immunotherapy for previously untreated unresectable malignant pleural mesothelioma. The post FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma appeared first on.

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FDA Approval Trials Clinical Development Development 57

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%

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Trials Clinical Trials Clinical Trials FDA Approval 84

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 57

FDA Approval Drugs Gene Therapy Protein 57

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).

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FDA Approval Clinical Development Drugs Medicine 130

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.

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Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Initial approval in 1994: FDA, U.S.

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Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

Trials 52

Trials Clinical Trials Clinical Trials FDA Approval 52

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.

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Gene Therapy Gene FDA Approval Trials 52

pharmaphorum

MAY 30, 2022

Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. Continuing to advance valuable combination therapies into the clinic, and finally, crack resistance to RAS targeted therapeutics.

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Development Drugs FDA Approval Clinical Trials 52

Delveinsight

SEPTEMBER 9, 2021

A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications. TransMedics receives FDA approval for its OCS heart system.

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FDA Approval Development Research Production 73

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.

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FDA Approval Trials Engineer Clinical Development 53

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).

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Clinical Trials Clinical Trials FDA Approval Trials 52

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.

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Trials Marketing FDA Approval Development 104

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

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.

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Gene Therapy Gene Trials Protein 80

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]

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FDA Approval HR Vaccination Vaccine 40

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 FDA Approval 52

Pharmaceutical Technology

AUGUST 5, 2022

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) recommended approving the treatment in this setting. This EC approval was based on findings from the parallel-group, double-blind, placebo-controlled, global Phase III OlympiA clinical trial of Lynparza versus placebo.

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FDA Approval DNA Clinical Trials Clinical Trials 147

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

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.

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Clinical Trials Clinical Trials Trials FDA Approval 57

XTalks

JULY 3, 2023

The US Food and Drug Administration (FDA) has given its approval to Suflave, a colonoscopy preparation product developed by Braintree Laboratories, a division of Sebela Pharmaceuticals. How Can Suflave Boost Patient Compliance? Sabela Pharmaceuticals says the product will be available by prescription starting in August.

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FDA Approval Compliance Clinical Trials Clinical Trials 97

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.

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FDA Approval Production Trials Clinical Development 97

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Clinical Development Development Medicine Clinical Trials 52

Roots Analysis

NOVEMBER 3, 2023

Despite their potential therapeutic benefits, NAMPT inhibitors have faced several challenges in clinical development. One of the main challenges is the development of drug resistance, as cancer cells can develop mechanisms to bypass the inhibition of NAMPT. Below, I have pasted a few figures from the analysis.

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