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. The drug generated domestic sales of $200.4 The drug generated domestic sales of $200.4

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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. billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one.

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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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XTalks

NOVEMBER 7, 2024

Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.” Journey Medical plans to make Emrosi available by early 2025 through dermatology clinics and pharmacies across the US.

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FDA Approval Dermatology Bacteria Clinical Trials 105

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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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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World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. 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

OCTOBER 4, 2022

Rolvedon is the first long-acting granulocyte colony-stimulating factor (GCSF) to be FDA-approved in over 20 years that is not a biosimilar. Our commercial team is in place and ready to engage key stakeholders immediately,” said Erin Miller, Senior Vice President, Sales and Marketing of Spectrum Pharmaceuticals.

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XTalks

JULY 14, 2022

Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. million in net sales last year, which is a year-over-year growth of 39 percent. There were no new safety signals reported in the trial. The drug has proven to be quite profitable for Horizon as it hit a record of $565.5

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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

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

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

DECEMBER 10, 2021

Biohaven’s Nurtec ODT is the first and only FDA-approved CGRP receptor antagonist available in a quick-dissolve ODT formulation. Based on the positive trial data, Biohaven says it plans to file a new drug application (NDA) for Zavegepant with the US Food and Drug Administration (FDA) in the first quarter of 2022.

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Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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XTalks

JUNE 20, 2022

Amvuttra’s FDA approval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. billion in global sales by 2026. Pfizer has not one but two approved ATTR cardiomyopathy therapies, Vyndaqel and Vyndamax, which secured $2 billion in sales last year.

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

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XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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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

AUGUST 22, 2022

The med brought in $58 million in sales last year for Jazz. In addition to those candidates, Axosome acquired Sunosi, a drug for sleep apnea and narcolepsy, from Jazz Pharmaceuticals for $53 million this year.

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pharmaphorum

DECEMBER 21, 2021

Despite the success tied to the vaccine rollout, analysing data is still a daily challenge for many life sciences and pharmaceutical companies. This makes tools like augmented analytics essential to helping pharmaceutical and life sciences companies dig deeper into their data. Discover patient patterns to improve care .

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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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XTalks

JANUARY 27, 2023

Hyftor became the first FDA-approved topical treatment for facial angiofibroma associated with tuberous sclerosis.

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XTalks

DECEMBER 19, 2024

The US Food and Drug Administration (FDA) has rejected Johnson & Johnsons (J&J) application for a subcutaneous formulation of Rybrevant (amivantamab). In August, the FDA approved Janssen Biotechs EGFR kinase inhibitor Lazcluze in combination with Rybrevant as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations.

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XTalks

NOVEMBER 15, 2023

Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.” It appears the company has already done so as its quarterly earnings report included $96 million and $117 million of additional revenue from the sale of the PRV in its 2023 revenue guidance.

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XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva made pharma data intelligence firm Evaluate’s list of top ten drug launches this.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. While Eylea’s sales have been on the decline, Vabysmo has been picking up steam.

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XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

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XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.

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XTalks

AUGUST 19, 2021

The flagship version, Xyrem, was first approved and marketed in 2002 as the first treatment for cataplexy and narcolepsy and continues to remain as such. billion in sales. In 2020, it garnered $1.74 However, the drug will lose its market exclusivity in 2023, at which time Jazz hopes patients will shift to Xywav.

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XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. More potential patients equal more prescriptions which equals higher sales and bigger profits.

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XTalks

FEBRUARY 10, 2023

ROP is a leading cause of childhood blindness worldwide and Eylea is the first pharmacologic approved for the disease. The only other FDA-approved treatment for ROP is laser photocoagulation, a complex laser surgery that can cause damage to retinal tissue with potential long-term complications. billion in sales in the US.

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XTalks

JANUARY 17, 2023

Related: Lung Disease Diagnostic Xenoview Gets FDA Approval for Use with MRI. In light of this, he said the approval “is good news” for this segment of adult asthmatics who make up more than 80 percent of asthma patients in the US. The FDA approval was based on results from the MANDALA, DENALI and TYREE Phase III studies.

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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

JUNE 6, 2024

Despite the more than 60 percent decline in sales, also experienced by Pfizer last year, which Moderna was expecting to be steeper, there were some silver linings. Moderna and Merck are also conducting a late-stage study of the vaccine and Keytruda combination. With the inevitable falloff of COVID-19 vaccines, Moderna earned $6.8

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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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XTalks

JULY 4, 2024

This blog delves into the top 30 drugs to watch in 2024, leveraging insights from their sales performance in 2023. These medications have not only redefined therapeutic standards across various medical conditions but have also showcased impressive sales figures, innovative advancements and expanded indications. billion DKK ($21.1

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