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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XTalks

MARCH 30, 2022

The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication.

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XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. The FDA approval sent Daiichi Sankyos shares soaring by 8.7%

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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

MARCH 10, 2025

The FDA has approved Genentechs TNKase (tenecteplase) for the treatment of acute ischemic stroke in adults, marking a milestone as the first new stroke medicine approved in nearly three decades.

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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. 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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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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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

SEPTEMBER 6, 2022

Gastric ulcers may also be caused by an overuse of NSAIDs like ibuprofen or aspirin, especially if these anti-inflammatory medicines were taken at high doses or for a long time. Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines.

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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

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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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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World of DTC Marketing

JANUARY 24, 2022

Particularly attractive are medicines ahead of the curve, aimed at diseases likely to move into the spotlight over the next few years. A group of early-stage life science investors and biotech CEOs joined together with a prominent patient advocate to speak out against H.R.3, Only about $2.2

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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Results from the ALPINE study have been published in the New England Journal of Medicine. 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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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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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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XTalks

JANUARY 5, 2021

Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials. AI is expected to make significant strides in the life science and healthcare sectors in 2021. AI approaches can also be useful in developing personalized and precision medicines.

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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. The clinical trial results were published in the New England Journal of Medicine in March 2021. “Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it.

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XTalks

AUGUST 2, 2023

Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Eichenfield.

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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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XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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XTalks

JANUARY 13, 2023

FDA approval represents achievement of a major milestone for Polarean’s technology. In the US, about 37 million people live with chronic lung disorders such as chronic obstructive pulmonary disease (COPD) and asthma.

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XTalks

OCTOBER 16, 2024

Regulatory filings for Europe are also in progress, with a marketing authorization application submitted to the European Medicines Agency (EMA) in 2023. If approved, the biosimilar will be marketed in the European Union (EU). Dong-A ST plans to expand Imuldosa’s global footprint, aiming to secure additional regulatory approvals.

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XTalks

JUNE 3, 2024

In September 2023, Yesafili was granted marketing authorization by the European Medicines Agency (EMA), making it the first aflibercept biosimilar approved in the European Union (EU). It was also approved in the UK in November 2023. In the US, Biogen will market Yesafili.

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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

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XTalks

NOVEMBER 12, 2024

Aucatzyl’s FDA approval was based on results from the FELIX trial of obecabtagene autoleucel in adult patients at least 18 years of age with r/r B-ALL who had bone marrow blasts level of at least five percent. Aucatzyl will be made at Autolus’ Nucleus, its dedicated commercial manufacturing site, located in Stevenage, UK.

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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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XTalks

JUNE 2, 2021

The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies. The oral treatment was approved for adults with locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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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.

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XTalks

MARCH 29, 2022

Jazz Pharmaceuticals has broken ground on a new $100 million manufacturing plant for cannabis-based medicines in the UK. The facility will be constructed in Kent Science Park (KSP) in Sittingbourne, an industrial town in Kent, England. After acquiring British cannabis-based medicine developer GW Pharmaceuticals in 2021 in a $7.2

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pharmaphorum

JULY 19, 2021

A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK. A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route.

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XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease caused by type 2 (allergic) inflammation.

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XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

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XTalks

FEBRUARY 26, 2024

XTALKS WEBINAR: On-Demand Code-Level Claims Data: Driving Actionable Insights and Efficiencies Live and On-Demand: Wednesday, April 3, 2024, at 1pm EDT (5pm GMT/UK) Register for this free webinar to learn how code-level claims data is a crucial dataset to address various needs across the life sciences and medical device landscape.

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XTalks

JULY 3, 2024

We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company.

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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. Personalized Medicine. AI/ML Technology.

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XTalks

JUNE 8, 2022

Riabni (rituximab-arrx), a CD20-directed cytolytic antibody and biosimilar to Rituxan, got approval from the US Food and Drug Administration (FDA) on Monday for adults with moderate to severe RA. This marks a new indication for Riabni, the fifth FDA-approved biosimilar by the biopharma Amgen. Amgen’s Biosimilars.

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