XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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XTalks

JANUARY 18, 2023

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks.

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XTalks

JUNE 23, 2022

In this episode, Ayesha and the team talked about the FDA approval of Eli Lilly’s JAK inhibitor Olumiant for the treatment of alopecia areata, also commonly just known as alopecia. The drug has become the first approved systemic treatment for the autoimmune disorder that causes patchy hair loss.

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Life Science FDA Approval Protein Drugs 52

XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices.

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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

AUGUST 23, 2023

BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Life Science Clinical Trials Clinical Trials FDA Approval 98

XTalks

DECEMBER 18, 2023

Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). In the statement, Merck said Welireg’s approval for advanced renal cell carcinoma makes it the first drug in its class approved for the disease and the first in a novel therapeutic class since 2015.

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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.

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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 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

NOVEMBER 28, 2023

Kesin Pharma has obtained approval from the US Food and Drug Administration (FDA) for its oral suspension antibiotic drug Likmez (metronidazole), designed for patients with dysphagia and difficulty swallowing. Likmez offers a safer alternative by mitigating the associated risks linked to off-label drug compounding.

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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. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. billion in 2025.

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XTalks

APRIL 3, 2024

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

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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

OCTOBER 19, 2022

In this episode, Ayesha discussed Elon Musk’s recent revelation that in addition to fasting, he also used Novo Nordisk’s weight loss drug Wegovy to help him get “lean and fit.” Musk is not affiliated with Novo so his endorsement of the drug came as a surprise, and could also be problematic according to some industry experts.

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Life Science FDA Approval Drugs Medicine 52

XTalks

MAY 11, 2022

In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM).

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Life Science FDA Approval Drugs Research 52

XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life.

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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 drug generated domestic sales of $200.4 million last year, of which $131.3

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XTalks

JUNE 29, 2023

This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause.

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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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FDA Approval Protein RNA Clinical Trials 105

XTalks

SEPTEMBER 29, 2022

In this episode, Ayesha discussed the FDA approval of bluebird bio’s Skysona for slowing the progression of neurologic dysfunction associated with the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in boys four to 17 years of age with early, active CALD. CDC Expresses Concern Over New COVID-19 Variant BF.7.

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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 2, 2024

Chiesi Global Rare Diseases, a specialized division within the Chiesi Group dedicated to pioneering therapies for individuals affected by rare diseases, has received approval from the US Food and Drug Administration (FDA) for Filsuvez (birch triterpenes) topical gel.

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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

MARCH 8, 2023

In this episode, Ayesha talked about the FDA approval of Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy, a leading cause of blindness. Hear more about the drug, including some questions about its clinical benefit.

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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 drug is the first CGRP receptor antagonist in a nasal spray formulation. Read the full articles here: Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results.

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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

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species. What is the Animal Drug Regulatory Process?

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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 26, 2022

In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP).

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Life Science FDA Approval Hormones Sales 52

XTalks

AUGUST 16, 2023

In this episode, Ayesha talked about the FDA approval of Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). However, the FDA rejected it in MDD and only handed the approval in PPD. Hear more about the drug and the approval/rejection in this episode.

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XTalks

MAY 2, 2022

Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. In the global VIOLET studies, 93.3 percent and 96.1 percent and 60.6

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XTalks

MAY 5, 2022

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. The US Food and Drug Administration (FDA) has approved two classes of drugs for the treatment of ADHD: stimulants and nonstimulants.

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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

MARCH 30, 2022

The editorial team discussed the increasing frequency of recalls of commonly prescribed drugs like blood pressure and diabetes medications. Should companies and regulators share more information about the steps being taken to address the issue of drug impurities? The recall affects lots produced between November 2019 and March 2022.

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Life Science Manufacturing FDA Approval Drugs 93

pharmaphorum

NOVEMBER 4, 2020

Ireland-based Fountain Healthcare Partners has raised another €125 million ($131 million) for its third life sciences fund – 25% ahead of its target – and says it will pump most of the money into European therapeutics and medical device companies. The third fund is now closed.

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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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