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

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.

FDA Approval 69

FDA Approval Bacteria Trials Protein 69

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 Life Science Sales Marketing 147

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

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 94

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.

FDA Approval 79

FDA Approval Life Science Clinical Trials Clinical Trials 79

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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FDA Approval Vaccine Vaccination Sales 52

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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FDA Approval Vaccination Vaccine Immune Response 64

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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FDA Approval Vaccination Vaccine In-Vitro 59

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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Sales Drugs FDA Approval Marketing 52

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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Allergies FDA Approval Drugs Protein 74

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

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

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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FDA Approval Drugs Clinical Trials Clinical Trials 94

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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FDA Approval Antibody Immune Response Drugs 78

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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FDA Approval Antibody Trials Drugs 101

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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FDA Approval Protein Genetics RNA 95

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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FDA Approval Vaccination Vaccine Trials 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.

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FDA Approval Manufacturing Trials Clinical Trials 52

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.

Sales 52

Sales FDA Approval Pharmacy Production 52

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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FDA Approval Trials Drugs Sales 83

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.

Medicine 147

Medicine Business Development Sales Life Science 147

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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FDA Approval Production Marketing Drugs 82

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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Life Science Drugs Development Genetic Disease 225

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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Life Science Sales Scientist Vaccine 115

XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

XTalks

JANUARY 27, 2023

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

Life Science 92

Life Science Genetic Disease FDA Approval Marketing 92

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.

FDA Approval 64

FDA Approval Drugs Regulation Sales 64

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.

FDA Approval 83

FDA Approval Clinical Trials Clinical Trials Sales 83

XTalks

NOVEMBER 7, 2024

Caplyta received US Food and Drug Administration (FDA) approval in 2019 for the treatment of schizophrenia. The Study 304 withdrawal trial is part of Intra-Cellular’s post-marketing commitment to the FDA, a standard requirement for antipsychotic medications. Relapse is a common occurrence with the disorder, with up to 81.9

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Trials Drugs Clinical Trials Clinical Trials 86

XTalks

FEBRUARY 9, 2024

As we delve into the top 15 cardiovascular disease drugs in 2023, guided by comprehensive 2022 sales data, we gain valuable insights into the market trends, drug efficacy and the evolving needs of patients worldwide. Read on to learn more about the top 15 cardiovascular disease drugs in 2023, based on 2022 sales statistics.

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Sales FDA Approval Drugs Marketing 59

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

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.

FDA Approval 83

FDA Approval Gene Therapy Antibody Gene 83

XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.

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Sales Insulin FDA Approval Drugs 52

XTalks

NOVEMBER 15, 2024

Despite expressing disappointment over its first-year performance, Pfizer scored a significant win last month with Abrysvo winning expanded US Food and Drug Administration (FDA) approval for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 18 to 59 who are at an increased risk of the disease.

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Vaccination Vaccine Gene Therapy RNA 71

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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Life Science Drugs FDA Approval Vaccine 79

XTalks

NOVEMBER 6, 2023

Phathom Pharmaceuticals received two US Food and Drug Administration (FDA) approvals for its first-in-class heartburn drug Voquenza (vonoprazan) spaced just three days apart for heliobacter pylori ( H. The FDA approval of the drug was based on results from the Phase III PHALCON-EE study that involved 1,024 patients with erosive GERD.

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FDA Approval Marketing Drugs Protein 64