XTalks

MARCH 9, 2022

In this episode, Ayesha spoke about some of the top women leaders in life science industries in celebration of International Women’s Day. In addition, the editorial team shared some of their experiences and insights as women in the life sciences.

Life Science 52

Life Science FDA Approval Development Drugs 52

XTalks

JANUARY 25, 2023

In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Susan Benton, Country Manager at Thea Pharma, an eye care company that focuses on developing innovative eye care treatments to help further the future of ophthalmic treatment. Susan Benton Country Manager Thea Pharma Inc.

Life Science 52

Life Science FDA Approval Business Development Production 52

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.

Life Science 52

Life Science FDA Approval Containment Scientist 52

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.

Life Science 52

Life Science FDA Approval Dermatology Pharmacy 52

XTalks

DECEMBER 20, 2023

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables.

Life Science 117

Life Science Gene Editing Development Clinical Trials 117

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.

Life Science 93

Life Science Clinical Trials Clinical Trials FDA Approval 93

XTalks

SEPTEMBER 14, 2022

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

Life Science 64

Life Science FDA Approval Insulin Drugs 64

XTalks

NOVEMBER 14, 2024

PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency.

Gene Therapy 89

Gene Therapy FDA Approval Gene Clinical Trials 89

XTalks

AUGUST 14, 2024

The guidelines now recommend CAMZYOS (mavacamten), the first and only FDA approved cardiac myosin inhibitor, as a Class 1 Level B-R therapy for the treatment of adults with obstructive HCM who have persistent symptoms after first-line therapy. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 72

Life Science Cardiology FDA Approval Medicine 72

XTalks

OCTOBER 30, 2024

Shorla Oncology recently received US Food and Drug Administration (FDA) approval to expand Jylamvo ’s (methotrexate) use for children with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.

FDA Approval 90

FDA Approval Drugs Clinical Trials Clinical Trials 90

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.

Life Science 52

Life Science FDA Approval Drugs Clinical Trials 52

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.

Gene Therapy 52

Gene Therapy FDA Approval Life Science Gene 52

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.

Life Science 52

Life Science FDA Approval Protein Drugs 52

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. AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer.

Life Science 52

Life Science FDA Approval Drugs Licensing 52

XTalks

OCTOBER 19, 2022

The editorial team also learned about the FDA approval of Nevro Corp’s AI-based spinal cord stimulation (SCS) system for the treatment of chronic pain. Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Drugs Medicine 52

XTalks

DECEMBER 8, 2021

The team also talked about a new hepatitis B vaccine from VBI Vaccines that received FDA approval for adults. The vaccine is the first three-antigen hepatitis B vaccine approved in the US. VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot.

Life Science 89

Life Science FDA Approval Vaccination Vaccine 89

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.

Gene Therapy 52

Gene Therapy Life Science FDA Approval Gene 52

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.

Life Science 52

Life Science FDA Approval Vaccination Vaccine 52

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.

Life Science 52

Life Science FDA Approval Drugs Trials 52

XTalks

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. She focuses on news relating to the food industry and writes blogs on recruitment and HR in the life sciences.

Life Science 105

Life Science HR Clinical Trials Clinical Trials 105

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. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Drugs 52

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Here are some of the top life science trends and topics from 2022. Gene Therapy Approvals. Manufacturer: bluebird bio Inc. AI/ML Technology.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

XTalks

MAY 11, 2022

Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Read the full articles here: Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer.

Life Science 52

Life Science FDA Approval Drugs Research 52

XTalks

OCTOBER 16, 2024

Hympavzi’s approval, with its innovative approach to balancing clotting, could offer a modern solution that adds to the global effort to reduce the risk of thrombosis. This is Pfizer’s second FDA-approved treatment for a rare genetic blood disorder this year.

FDA Approval 89

FDA Approval Trials Clinical Trials Clinical Trials 89

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).

Life Science 52

Life Science FDA Approval Hormones Sales 52

FDA Law Blog

JUNE 27, 2023

James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., HP&M’s Kurt R.

Life Science 80

Life Science FDA Approval Drugs Development 80

XTalks

APRIL 21, 2023

And in 2015 the US Food & Drug Administration (FDA) approved an assay on Theranos’ proprietary technology.” Life science startups face unique challenges given the highly regulated and complex nature of the industry. Outsiders who reviewed the technology said it worked.

Life Science 87

Life Science Trials Production Regulation 87

XTalks

AUGUST 12, 2024

Related: Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies “Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.

FDA Approval 102

FDA Approval Allergies Production Drugs 102

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. Read the full articles here: Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic.

Life Science 52

Life Science FDA Approval Trials Vaccine 52

XTalks

MARCH 15, 2023

Subscribe to the Xtalks Life Science Podcast to never miss a new episode. 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.

Life Science 81

Life Science FDA Approval Engineer Clinical Trials 81

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.

Filler 52

Filler Life Science FDA Approval Drugs 52

The Pharma Data

MAY 17, 2021

In fact, in recent times, tens of billions of dollars have flooded into the Midwest to accelerate life sciences innovation, and Illinois is ranked in the top 10 states in funding from the US National Institutes of Health. They provide a deep dive into the windy city’s standing in the life science space.

Life Science 52

Life Science Gene Therapy FDA Approval Gene 52

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.

Life Science 87

Life Science Drug Delivery FDA Approval Drugs 87

XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. Read the full articles here: Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Vaccination Vaccine 52

XTalks

MAY 29, 2024

Lee integrated protein crystallography and structural screening technologies into the company’s research programs and was instrumental in the development of phosphoinositide 3-kinase (PI3K) delta inhibitors, leading to an FDA-approved product. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science FDA Approval Drugs Development 52

XTalks

AUGUST 30, 2023

Ayesha also talked about the FDA approval of Regeneron’s high dose Eylea (HD Eylea) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The states say the $13.5 Hear more about the insulin pricing controversy in this episode.

Insulin 52

Insulin FDA Approval Life Science Production 52

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.

FDA Approval 94

FDA Approval Protein RNA Clinical Trials 94