XTalks

JULY 7, 2023

Pfizer’s alopecia JAK inhibitor Litfulo (ritlecitinib) has become its fourth US Food and Drug Administration (FDA) approved product in the past several weeks. Litfulo is entering the alopecia market to rival Eli Lilly’s Olumiant (baricitinib), which was approved as the first drug for alopecia areata a year ago.

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XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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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

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

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Gene Therapy FDA Approval Gene Clinical Trials 52

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. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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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 27, 2023

Chiesi Global Rare Diseases recently announced in a press release that Lamzede (velmanase alfa-tycv) received US Food and Drug Administration (FDA) approval for the treatment of non-neurological manifestations of alpha-mannosidosis in both adult and pediatric patients.

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Drug Discovery World

APRIL 27, 2023

Megan Thomas takes a snapshot of the US biotech market and some of the ongoing research coming out of the US. In 2021, Savills put together a report on the regional hubs attracting science/pharma investment 1. The Boston Globe headline 3 , ‘Life sciences is poised to be Boston’s dominant industry.

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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.

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XTalks

MAY 29, 2024

The Financial Times’ list of the Americas’ Fastest Growing Companies 2024 provides an insight into the market’s leaders in terms of growth, highlighting not the size of companies but their capacity for innovation. The list features companies from all spheres such as IT, Marketing, Finance and more.

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XTalks

MARCH 6, 2024

Other companies are developing targeted therapies against other pathological biomarkers in dementia and Alzheimer’s, including total and phosphorylated tau protein and neurofilament light (NfL). There have been several approvals recently for neuromodulation devices for the treatment of chronic pain as well.

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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. To date, over 200 mutations in the SOD1 gene have been associated with the development of ALS. How Does Qalsody Work?

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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

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

SEPTEMBER 17, 2021

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s The complex is designed to target the toxic unfolded proteins in the endoplasmic reticulum, as well as mitochondrial dysfunction, which is being increasingly recognized as a pathogenic mechanism underlying the disease. Unmet Medical Need.

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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. The disorder primarily affects males.

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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

DECEMBER 22, 2021

If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the life sciences. Here is a look at some life science trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.

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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. billion in 2032.

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XTalks

MAY 12, 2023

The MeCP2 protein plays a crucial role in regulating the activity of genes involved in brain development. In March, the US Food and Drug Administration (FDA) approved Daybue (trofinetide) , the first and only treatment for Rett syndrome. Daybue (trofinetide) is the first and only FDA-approved drug for Rett syndrome.

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XTalks

JUNE 8, 2021

SMA is caused by mutations in the survival motor neuron 1 ( SMN1) gene, which along with the SMN2 gene, encode the SMN protein. It is administered as a one-time IV administration and expression of the SMN protein from the gene improves muscle movement and function, and ultimately survival. With a price tag of over $2.5

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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.

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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 25, 2021

AbbVie (NYSE:ABBV) continues to face heat over complaints of patent exploitation and price hikes of its world’s best-selling drug Humira (adalimumab) to build a market monopoly and block out Humira biosimilar competition. According to the FDA, biosimilars are among the most rapidly growing class of therapeutic products in the US.

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The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Cornering the untapped Chinese CNS market, SciNeuro launched with $100 million in their pocket.

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XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

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XTalks

DECEMBER 4, 2023

The FDA said it is investigating the identified risk of developing the T-cell malignancies as secondary cancers with serious outcomes, including hospitalization and death, and also looking at the need for regulatory action.

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Drug Discovery World

DECEMBER 13, 2023

This article is sponsored by Fortis Life Sciences. Fortis Life Sciences offers custom antibody discovery and manufacturing services for antibodies and single-domain antibodies, supporting the drug discovery market. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A In February 2023, Pfizer revealed that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Abrysvo. percent and severe RSV-associated LRTD by 94.1

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XTalks

MAY 31, 2023

Between 2021 and 2022, the biotech IPO market experienced a notable decline as investors grew increasingly cautious due to the uncertainties surrounding the pandemic and economic downturn. One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A).

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XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

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FDA Approval Antibody Drugs Trials 98

XTalks

AUGUST 19, 2022

Beta thalassemia is a rare inherited blood disorder caused by mutations in the beta-globin gene leading to a reduced amount, or complete absence, of the beta chains of the oxygen-carrying hemoglobin protein in red blood cells. The estimated incidence of the disorder worldwide is one in 100,000. Zynteglo’s hefty price tag of $2.8

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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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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. Other New Treatments for NSCLC on the Market The FDA has recently approved several other medications for various subsets of NSCLC patients.

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XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. The marketing rights to Thiola were acquired by Retrophin in 2014 from Mission Pharmacol.

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