XTalks

OCTOBER 4, 2022

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?

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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

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

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

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

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

AUGUST 5, 2022

ChemoCentryx made its way into news in October 2021 when it clenched its first ever US Food and Drug Administration (FDA) approval in 24 years for the drug Tavneos (avacopan) for patients with serious autoimmune disease. Tavneos recorded US sales of $5.4 million during the first quarter of 2022.

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Development FDA Approval Sales Drugs 52

XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

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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FDA Approval Drugs Sales Development 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 100

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 29, 2024

Pfizer has also chosen to donate the rights of royalties from sales of Bavencio (avelumab) in the US to the American Association for Cancer Research (AACR). Looking ahead, Pfizer plans to leverage its expertise in protein engineering and medicinal chemistry to further develop Seagen’s antibody-drug conjugate (ADC) technology.

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XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death. billion in 2020, an increase of 20 percent.

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XTalks

JUNE 6, 2024

The prefusion conformation of the F protein is highly conserved across both RSV-A and RSV-B subtypes. mRESVIA’s approval was based on data from the Phase III ConquerRSV study involving 37,000 adults 60 years of age and older across 22 countries. So far in the RSV vaccine arena, GSK’s Arexvy has generated 1.2 billion pounds ($1.5

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XTalks

DECEMBER 4, 2023

In a statement outlining its investigation, the FDA said it received reports of the T-cell malignancies from clinical trials and post-marketing safety monitoring. The currently approved therapies target CD19 and BCMA, which are expressed in cancers like B-cell lymphoma and multiple myeloma.

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XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. The deal will give AbbVie unspecified royalties on Amjevita sales.

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Production Drugs Marketing Sales 98

The Pharma Data

JANUARY 18, 2021

About Chemerin and its receptor: The chemerin receptor (“CMKLR1”, also known as ChemR23) is a chemokine like G protein-coupled receptor (“GPCR”) expressed on select populations of cells, including inflammatory mediators (including macrophages, monocytes, plasmacytoid/myeloid dendritic cells and natural killer cells), as well as epithelial cells.

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Life Science Development Sales Drugs 40

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43

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XTalks

DECEMBER 5, 2023

As its active ingredient, repotrectinib inhibits the proto-oncogene tyrosine-protein kinase ROS1 and the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB and TRKC. Analysts at William Blair estimate that Augtyro’s sales could climb to $258 million by 2027, contingent on its anticipated approval in Europe next year.

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Protein FDA Approval Medicine Trials 115

XTalks

MAY 31, 2023

One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). With an extensive product lineup, Kenvue achieved net sales of around $15 billion in 2022 , serving a broad customer base of 1.2 percent of the total outstanding shares of Kenvue’s common stock (or 89.6

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Clinical Trials Clinical Trials Trials Production 97

XTalks

AUGUST 10, 2022

HER2-low is characterized by the presence of some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive. In the US, it is estimated that 287,850 new cases of female breast cancer will be diagnosed in 2022, according to data from the National Cancer Institute (NCI) outlined by the FDA.

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XTalks

JANUARY 4, 2024

Hemophilia B, also known as congenital Factor IX (FIX) deficiency or Christmas disease, is a rare genetic bleeding disorder caused by a deficiency or defect in the FIX clotting protein. Treatment involves replacing the missing FIX clotting protein, traditionally through regular infusions. Priced at $3.5

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XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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The Pharma Data

JANUARY 13, 2021

Vivity received FDA approval in February 2020. Under terms of the deal, Sirion is entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success. The approval follows the FDA’s pre-licensure inspection in September 2020.

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XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

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