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.

Life Science 98

Life Science FDA Approval Engineer Clinical Trials 98

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

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

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.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

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

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. The clinical study also highlighted the favorable tolerability profile of Filsuvez. The most commonly reported adverse reactions in the clinical trial were pruritus (itching) and pain at the wound application site, occurring in 7.3

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

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.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

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 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.

Life Science 52

Life Science Vaccination Vaccine FDA Approval 52

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Regulation 100

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.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

Clinical Trials 104

Clinical Trials Clinical Trials Trials Engineer 104

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.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

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.

Life Science 52

Life Science Trials FDA Approval Hormones 52

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).

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Contamination 98

XTalks

OCTOBER 4, 2022

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. Clinical Trials and Commercialization. How Does Rolvedon Work?

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

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

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

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. The non-inferiority of Cyfendus to BioThrax was statistically determined in the clinical study results. Additionally, at Day 64, 86.6 percent in the BioThrax group.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

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.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

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.

FDA Approval 98

FDA Approval Big Data Life Science Clinical Trials 98

XTalks

OCTOBER 4, 2022

Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. XTALKS WEBINAR: Response Prediction in Oncology Clinical Trials. Clinical Trials of Elucirem.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

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.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

XTalks

NOVEMBER 10, 2023

Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.” No adverse events were reported during the clinical trials following the administration of Adzynma. Adzynma’s approval is the second for Takeda this week.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

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).

FDA Approval 147

FDA Approval Sales Life Science Marketing 147

XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

JULY 20, 2022

Read the full articles here: Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19. Krystexxa Chronic Gout Medication Gets Expanded FDA Approval. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 52

Life Science Vaccination Vaccine Drugs 52

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.”

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 BMS had targeted Camzyos in its acquisition of MyoKardia in 2020 for $13.1

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

Life Science 98

Life Science Vaccination Vaccine Trials 98