Pharmaceutical Technology

APRIL 12, 2024

SK Life Sciences Xcopri (cenobamate) is approved as an oral suspension mixed with water for mouth administration or via a nasogastric tube.

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FDA Approval Life Science 130

XTalks

SEPTEMBER 12, 2023

Life science podcasts have emerged as an invaluable tool for building connections with audiences in the digital era. Furthermore, we’ll explore the unique advertising opportunities that this platform offers, positioning brands at the forefront of the life science industry. The result?

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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.

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Life Science FDA Approval Insulin Drugs 90

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.

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Life Science HR Clinical Trials Clinical Trials 105

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.

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Life Science Gene Editing Development Clinical Trials 119

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

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.

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Life Science Trials Production Regulation 98

XTalks

DECEMBER 22, 2021

If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the life sciences. Here is a look at some life science trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.

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XTalks

FEBRUARY 19, 2025

The FDA has approved Decipheras Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may lead to worsened joint function or severe complications. The approval was largely based on the results of the MOTION Phase III study.

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XTalks

MARCH 3, 2022

Developed in partnership with Legend Biotech Corp of China, Johnson & Johnson’s cell therapy Carvykti (formerly known as cilta-cel) received approval from the US Food and Drug Administration (FDA) this week for the treatment of multiple myeloma. Live and On-Demand: March 16, 2022 | 9am EDT (NA) / 1pm GMT (UK).

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FDA Approval Life Science Production Trials 98

XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. a biotech company specializing in the development and commercialization of genetic medicines for rare diseases, announced FDA approval for Vyjuvek for the treatment of DEB.

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FDA Approval Gene Therapy Gene Trials 111

XTalks

MARCH 30, 2022

This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines.

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Life Science Manufacturing FDA Approval Drugs 93

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

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FDA Approval Drugs Gene Trials 99

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.

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Life Science FDA Approval Engineer Clinical Trials 75

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.

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Life Science FDA Approval Drugs Development 81

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.

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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. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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FDA Approval Genetics Gene Therapy Gene 105

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.

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FDA Approval Allergies Production Drugs 105

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

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

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XTalks

JUNE 21, 2024

Additional data from the Phase III STRIDE-4 and STRIDE-6 studies, which assessed Capvaxive in vaccine-naïve and vaccine-experienced adults, also helped seal the approval. Related: Pneumococcal Vaccination for Adults: Conversation with Vaccine Scientists Dr. Heather Platt and Dr. Ulrike Buchwald from Merck – Xtalks Life Science Podcast Ep.

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FDA Approval Vaccination Vaccine Life Science 108

XTalks

SEPTEMBER 6, 2022

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension). John’s University College of Pharmacy & Health Sciences, Queens, New York.

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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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FDA Approval Drugs Clinical Trials Clinical Trials 98

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.

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FDA Approval Trials Clinical Trials Clinical Trials 105

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.

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Life Science Vaccination Vaccine Trials 98

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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FDA Approval Bacteria Trials Protein 95

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

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FDA Approval Life Science Clinical Trials Clinical Trials 97

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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Botox FDA Approval Cosmetics Clinical Trials 98

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

DECEMBER 18, 2023

Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). The oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor was first approved in August 2021 for von Hippel-Lindau (VHL), a rare hereditary disease that causes tumor growth in different organs, particularly the kidney.

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FDA Approval Drugs Sales Medicine 98

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.

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Life Science Cardiology FDA Approval Medicine 72

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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FDA Approval Big Data Life Science Clinical Trials 98

XTalks

DECEMBER 7, 2021

The FDA approval for VBI Vaccines’ hepatitis B shot was based on data from two pivotal Phase III studies, PROTECT and CONSTANT, results of which were published in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021, respectively.

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XTalks

MARCH 9, 2023

The efficacy data used for the FDA-approved label is based on post-hoc sensitivity analysis evaluating only the first 281 randomized patients in the trial. There are risks associated with birth defects and liver harm, so Filspari is only available through an FDA-approved Risk Evaluation and Mitigation Strategy.

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XTalks

OCTOBER 25, 2022

Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo’s approval was based on results from the HIMALAYA Phase III trial , which showed that patients treated with the Imjudo and Imfinzi combination experienced a 22 percent reduction in the risk of death versus sorafenib.

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FDA Approval Trials Drugs Immune Response 98

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

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FDA Approval Dermatology Trials Clinical Trials 98

XTalks

SEPTEMBER 12, 2022

The FDA approval was based on data from the randomized, double-blind, placebo-controlled ASCEND study involving 31 adult patients. The FDA approval came ahead of its October 3 target date, which had been extended by three months. Patients in the trial received Xenpozyme or placebo for 52 weeks.

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FDA Approval Genetics Trials Gene 98