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.

FDA Approval 52

FDA Approval HR Trials Hormones 52

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

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

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).

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

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%

Development 147

Development Drugs Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

FDA Approval 130

FDA Approval Clinical Development Drugs Medicine 130

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. Bringing a new cancer drug to market costs an average of $2.8 Bringing a new cancer drug to market costs an average of $2.8

Trials 98

Trials Clinical Trials Clinical Trials FDA Approval 98

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

Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

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Antibody Marketing Drugs Licensing 98

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

FEBRUARY 21, 2022

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. Renal complications were reduced by 18%.

Drugs 122

Drugs Trials Insulin FDA Approval 122

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

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 Vaccination Vaccine 40

The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 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.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 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.

FDA Approval 147

FDA Approval DNA Clinical Trials Clinical Trials 147

pharmaphorum

MAY 30, 2022

For decades, RAS has existed as an elusive therapeutic target, and drugging this high-value oncogene was deemed impossible. 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.

Development 52

Development Drugs FDA Approval Clinical Trials 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

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.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

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.

FDA Approval 97

FDA Approval Compliance Clinical Trials Clinical Trials 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

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 Vaccination Vaccine Development 52

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

Drugs 98

Drugs Antibody Pharma Companies Development 98

XTalks

JANUARY 6, 2021

Psychedelic drugs are rapidly becoming mainstream as various research supports their effectiveness in alleviating mental health problems. Psychedelic drugs such as LSD, psilocybin, ketamine and more are being studied to explore their effects on mental illnesses, like depression.

Drugs 97

Drugs Clinical Trials Clinical Trials Medicine 97

Pharmaceutical Technology

MARCH 1, 2023

The FDA approval of Sarepta’s Exondys 51 to treat Duchenne muscular dystrophy (DMD) and the approval of Ionis’ Spinraza to treat spinal muscular atrophy (SMA) in 2016 marked critical milestones in the field, as the first ASO drugs to enter the market.

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RNA Vaccination Vaccine Genetics 147

Roots Analysis

DECEMBER 18, 2023

The next generation drug conjugate is relatively a new concept. This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Endocyte also developed other small molecule drug conjugates for the treatment of cancer and renal disorders.

Drugs 40

Drugs FDA Approval Antibody Development 40

Drug Discovery World

FEBRUARY 14, 2024

AlphaMedix is a targeted alpha therapy currently in Phase II clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. In the Phase I study, treatment was well-tolerated, with a response rate of 62.5%

In-Vivo 52

In-Vivo FDA Approval Clinical Trials Clinical Trials 52

XTalks

OCTOBER 26, 2022

Additionally, the company revealed the latest five-year data from two Phase III studies (Study 1489 and Study 1490) at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) showing the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen.

Drugs 98

Drugs Containment FDA Approval Marketing 98

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is a new molecular entity (NME).

Recombinant DNA Technology 100

Recombinant DNA Technology Production Antibody FDA Approval 100

XTalks

NOVEMBER 20, 2023

XTALKS WEBINAR: FDA Oncology Center of Excellence: Programs & Projects That Impact Drug Development Live and On-Demand: Thursday, December 7, 2023, at 9:30am EST (3:30pm CET/EU-Central) Register for this free webinar to learn about the FDA Oncology Center of Excellence’s special projects and programs.

HR 98

HR FDA Approval Gene Trials 98

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The data hint approved COVID-19 drugs will be used extensively in Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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Trials Research Drugs Protein 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial.

FDA Approval 52

FDA Approval Production Trials Clinical Trials 52

XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). percent (95 percent CI: 46.2 percent, 79.2

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Protein FDA Approval Medicine Trials 115

XTalks

JUNE 9, 2022

It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. The drug was well-tolerated by patients except for two adverse events that were deemed unrelated to the therapy.

Trials 52

Trials Antibody Genetics Gene 52