XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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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

OCTOBER 4, 2022

Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malignancies on myelosuppressive anti-cancer drugs. How Does Rolvedon Work?

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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

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. XTALKS WEBINAR: Novel Protein-Like Synthetic Polymers with Superior Properties as Therapeutics, Diagnostics and Targeted Delivery Agents.

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XTalks

JANUARY 5, 2021

There will also be more focus on digitization of research and development and manufacturing spaces to increase efficiencies and interconnectivity in the pharma, biotech and medical device industries. Despite this, the FDA recently approved the first over-the-counter, fully at-home antigen test for COVID-19.

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XTalks

MARCH 10, 2023

But with Skyclarys (omaveloxolone), the first and only drug to treat Friedreich’s ataxia in patients aged 16 years and older, Reata Pharmaceuticals has developed a new treatment option to improve neurological function. This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher.

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XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis.

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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

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

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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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XTalks

SEPTEMBER 16, 2022

People with psoriasis are also at risk of developing additional health conditions, such as cardiovascular disease. In addition, patients may also develop psoriatic arthritis , which causes swelling and pain around the joints. Due to these symptoms, psoriasis has a significant impact on patients’ quality of life.

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XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG). How Does Rystiggo (Rozanolixizumab) Work?

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XTalks

DECEMBER 29, 2023

. “The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M.

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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. Jardiance (Empagliflozin) Jardiance sales in 2022: $8.388 billion Company/Developer: Boehringer Ingelheim and Eli Lilly & Co. Jardiance brought in $2.06

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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. The sale of Tavneos has been approved in the US, European Union, Canada and Japan.

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XTalks

NOVEMBER 30, 2023

Global entities such as the WHO, the Global Fund and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have developed comprehensive strategies aligned with Sustainable Development Goal (SDG) target 3.3, This marked the first FDA-approved injectable, complete regimen for HIV-infected adults, administered once a month.

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Drug Discovery World

APRIL 27, 2023

The report notes that the focus on science and pharma throughout the Covid-19 pandemic has resulted in the emergence of new locations as life science hubs and name checks Boston, Massachusetts and San Francisco, California as examples of centres with heightened investment appeal in the life sciences 1.

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XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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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

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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XTalks

FEBRUARY 20, 2024

have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for sibeprenlimab, an investigational drug intended for treating immunoglobulin A (IgA) nephropathy, commonly known as Berger’s disease. Consequently, this damage causes blood and protein leakage into the urine.

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XTalks

MARCH 28, 2024

Colorectal Cancer: Advances in Treatment Options In recent years, there has been considerable progress in understanding the biology of CRC, which has helped develop more effective and personalized treatment options. An overview of some of the most promising developments in CRC treatment is provided below.

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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). On the other, the development of smaller, portable MRI machines is favored for their ease and convenience.

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XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. Why is the approval of Lunsumio a significant milestone for Genentech and Roche?

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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XTalks

JUNE 15, 2022

The Novavax COVID-19 vaccine was recommended for emergency use in adults by the World Health Organization (WHO) in December 2021 , and is approved in over 40 countries. The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. The Novavax COVID-19 Vaccine Candidate.

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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. Imbruvica (Ibrutinib) Imbruvica 2022 sales: $8.352 billion Company/Developer: Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.,

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XTalks

MAY 9, 2024

We also invented four proprietary antibody technologies, including our DuoBody® bispecific technology which is the backbone of four FDA-approved bispecifics and over ten in development. Genmab has achieved notable success with eight approved therapies and an impressive pipeline.

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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 2, 2023

People with asthma should collaborate with their healthcare provider to develop a personalized treatment plan that meets their specific needs. This can help support the development of new treatments and therapies for people with asthma. What is the Theme of World Asthma Day 2023?

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XTalks

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. The study involved food challenges where participants were given gradually increasing amounts of foods they are allergic to and a placebo ingredient.

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XTalks

AUGUST 17, 2020

Duchenne muscular dystrophy (DMD) patients with a mutation in exon 53 of the dystrophin gene now have a second approved treatment option, and Xtalks spoke with Sharon Hesterlee, PhD, Muscular Dystrophy Association executive vice president and chief research officer, to learn more.

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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. Rett syndrome is characterized by a distinctive pattern of symptoms that gradually emerge after a period of seemingly normal development. Daybue (trofinetide) is the first and only FDA-approved drug for Rett syndrome.

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