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

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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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).

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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

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 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

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

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

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

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

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

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

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

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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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

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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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

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.

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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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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 27, 2023

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

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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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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

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024. billion ($1.5 billion) for the year.

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Drugs FDA Approval Sales Vaccination 52

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

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

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

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

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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XTalks

FEBRUARY 5, 2024

GSK declared Arexvy to be a blockbuster in its first year on the market after higher-than-expected sales. GSK revealed in its 2023 annual and quarterly earnings report last week that sales of Arexvy totaled $1.5 GSK said it has secured about two-thirds share of the US market where nearly all of Arexvy’s sales were recorded.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year. billion in peak annual sales of Roctavian.

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XTalks

FEBRUARY 16, 2023

However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. estimating Indorsia spent $6.2

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XTalks

JULY 10, 2023

“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Since its approval in May 2022, Mounjaro sales have hit $1.4

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