XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy. AstraZeneca is also venturing into cell therapy and genetic medicine.

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Drug Discovery World

MARCH 7, 2023

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. The life sciences sector has traditionally outperformed others when it comes to attracting women to its workforce. Dr Loubna Bouarfa, Founder and CEO, OKRA.ai

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XTalks

AUGUST 31, 2022

In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD.

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XTalks

MAY 4, 2022

In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. Read the full articles here: Oteseconazole (Vivjoa) Becomes First FDA-Approved Drug for Recurrent Yeast Infection.

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XTalks

OCTOBER 25, 2023

Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

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XTalks

FEBRUARY 2, 2022

In this episode, Ayesha talked about the recent FDA approval for Immunocore’s Kimmtrak for the treatment of a rare type of eye cancer called uveal melanoma. The editorial team also discussed how Pfizer and Moderna have commenced trials for their respective omicron-based vaccines.

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XTalks

NOVEMBER 23, 2022

In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made.

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XTalks

AUGUST 10, 2022

Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The approval makes Enhertu the first approved drug for this indication.

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XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Safety and Efficacy of Filsuvez The FDA’s approval of Filsuvez is supported by compelling clinical evidence. Specifically, 41.3 percent observed in the control gel arm. percent of cases.

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XTalks

SEPTEMBER 7, 2022

Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor’s first approval for a pediatric indication, and the first approved liquid form of the drug.

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XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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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

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XTalks

MARCH 15, 2023

Read more here: Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial The weekly podcast is available for streaming every Wednesday on Spotify , Apple Music and wherever you stream your podcasts. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

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XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The team also talked about results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine in adults. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Read more about the vaccine, including clinical trial results on its efficacy and safety.

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XTalks

NOVEMBER 10, 2021

Pfizer released data from an interim analysis of a Phase III trial evaluating the drug, which shows that it can reduce the risk of hospitalizations by almost 90 percent. The results were so strong that an independent data monitoring committee and the FDA told Pfizer they could stop enrolling participants in the trial.

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XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). months in the KEYNOTE-057 trial.

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XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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XTalks

OCTOBER 27, 2021

In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech.

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XTalks

OCTOBER 4, 2022

The life expectancy of HRS-affected patients is very low, and the only definitive treatment is liver transplantation. XTALKS WEBINAR: Time for Change in NASH: How Non-Invasive Biomarkers are Driving a Paradigm Shift in Clinical Trials and Clinical Care. Outcomes of Clinical Trials of Terlipressin. percent (vs. percent (vs.

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pharmaphorum

JANUARY 12, 2023

Avillion – clinical co-development partner with AZ – conducted the global phase 3 trial of over 4,000 patients across four studies (including the MANDALA and DENALI trials). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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XTalks

JULY 25, 2023

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Moreover, the clinical trials demonstrated that Cyfendus exhibited a favorable tolerability profile. Additionally, at Day 64, 86.6 percent in the BioThrax group.

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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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XTalks

MAY 2, 2022

This is the very first approval for a medication for the chronic version of VVC. The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need. For Mycovia Pharmaceuticals , Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections.

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XTalks

DECEMBER 13, 2023

This approval also marks bluebird’s third ex vivo gene therapy approved by the FDA for a rare genetic disease and second FDA approval for an inherited hemoglobin disorder, cementing our position as a gene therapy leader.”

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XTalks

OCTOBER 18, 2022

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain. HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care,” said D.

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XTalks

OCTOBER 4, 2022

XTALKS WEBINAR: Decentralization in Action: What Oncology Trials Look Like Now. Register for this free webinar to learn new ways to operationalize hybrid oncology trials and how virtual sites help reduce patient burden. The featured speakers will discuss where the industry is headed with decentralized clinical trials and oncology.

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XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. The recommended dosage of Izervay is 2 mg (equivalent to 0.1

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XTalks

MAY 5, 2022

There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

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Pharmaceutical Technology

MARCH 14, 2023

Biopharmaceutical firm Cingulate and life sciences commercialisation firm Indegene have entered into a joint commercialisation deal for the former’s attention-deficit/hyperactivity disorder (ADHD) therapy CTx-1301 (dexmethylphenidate). The company expects to receive data from the trial in the third quarter of this year.

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