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 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

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

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

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

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

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 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

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

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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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

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 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

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.

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pharmaphorum

JANUARY 12, 2023

Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval. The results were published in the New England Journal of Medicine in May last year.

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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

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.” It’s also been granted orphan designation by the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of TTP.

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Drug Discovery World

FEBRUARY 24, 2023

Abbey Vangeloff is the Director of Business Development, Life Sciences, at Yahara Software. DDW’s Megan Thomas catches up with Vangeloff to learn why AI and data science are so important for the future of the sector. This, Vangeloff says, is the part they get excited about when working with life science clients.

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. In the EU, Skyclarys has been granted the Orphan Drug designation and is under review by the European Medicines Agency (EMA). What is Friedreich’s Ataxia?

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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

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.

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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

MARCH 13, 2024

The voiceover calls out how “some people have been using medicine never meant for them, for the smaller dress or tux, for a big night, for vanity. From camera flashbulbs on the red carpet, the ad then cuts to a scene of a woman on a subway, representing the intended consumer or patient of the medicines. But that’s not the point.”

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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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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

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

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

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

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XTalks

JANUARY 9, 2023

The primary results of the CAPELLA study were published in the New England Journal of Medicine in May 2022. Both cohorts are part of this ongoing maintenance period of the study, in which the efficacy and safety of subcutaneous lenacapavir administration every six months in combination with an optimized background regimen is being evaluated.

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XTalks

JULY 7, 2021

In this episode, Ayesha talks about the launch of a digital marketing campaign for the first FDA-approved therapeutic video game to help treat ADHD. It was developed by digital medicine company Akili Interactive. Read the full articles here: Akili Launches Digital Ad Campaign for First FDA-Approved ADHD Video Game.

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XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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XTalks

JUNE 16, 2023

Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” Other authors on the paper include Sydney A.

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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

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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