XTalks

MARCH 3, 2022

Developed in partnership with Legend Biotech Corp of China, Johnson & Johnson’s cell therapy Carvykti (formerly known as cilta-cel) received approval from the US Food and Drug Administration (FDA) this week for the treatment of multiple myeloma. Live and On-Demand: March 16, 2022 | 9am EDT (NA) / 1pm GMT (UK).

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XTalks

AUGUST 12, 2024

Related: Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies “Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.

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XTalks

MARCH 30, 2022

The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication.

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XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Regarding the price of Filsuvez, it has not yet been publicly disclosed by the company.

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FDA Law Blog

JUNE 27, 2023

James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., HP&M’s Kurt R.

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XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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XTalks

JANUARY 25, 2023

In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Susan Benton, Country Manager at Thea Pharma, an eye care company that focuses on developing innovative eye care treatments to help further the future of ophthalmic treatment. Susan Benton Country Manager Thea Pharma Inc.

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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.

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XTalks

SEPTEMBER 6, 2022

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension). John’s University College of Pharmacy & Health Sciences, Queens, New York.

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XTalks

MAY 2, 2022

This is the very first approval for a medication for the chronic version of VVC. The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need. For Mycovia Pharmaceuticals , Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections.

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XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent.

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XTalks

JANUARY 13, 2023

Medical imaging tech company Polarean Imaging has recently announced that the US Food and Drug Administration (FDA) has approved their drug-device combination product Xenoview (xenon Xe 129 hyerpolarized). FDA approval represents achievement of a major milestone for Polarean’s technology.

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XTalks

OCTOBER 4, 2022

The life expectancy of HRS-affected patients is very low, and the only definitive treatment is liver transplantation. We’re excited to bring Terlivaz to US patients and physicians and plan to launch the product in the coming weeks,” said Siggi Olafsson, President and Chief Executive Officer of Mallinckrodt.

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XTalks

OCTOBER 16, 2024

Stelara now has a new biosimilar option on the market, as Dong-A ST’s Imuldosa (ustekinumab-srlf) has received approval from the US Food and Drug Administration (FDA) for the treatment of several autoimmune conditions. Imuldosa’s approval followed a rigorous review process by the FDA.

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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. We expect to have product available in the fourth quarter of 2022 following the fulfillment of customary, pre-launch regulatory requirements,” added Miller. How Does Rolvedon Work?

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XTalks

JUNE 3, 2024

Yesafili and Opuviz are approved to treat the same conditions as Regeneron’s vascular endothelial growth factor (VEGF) inhibitor Eylea — neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy, macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME). According to Biocon, there are 19.8

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XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

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XTalks

MARCH 10, 2025

The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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XTalks

FEBRUARY 18, 2025

The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Merilog is approved for use in adults and pediatric patients six years of age and older. If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.

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XTalks

AUGUST 19, 2022

Along with beti-cel, there is one being developed for sickle cell (approved in Europe as Skysona or eli-cel) and another being jointly developed with Bristol Myers Squibb for melanoma. The road to Zynteglo’s approval was a bit rocky and included an FDA delay (the most recent in June) over production test concerns.

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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. If accidental exposure does occur, immediate administration of epinephrine to treat anaphylaxis is required. However, the treatment is restricted to peanut allergy.

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XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life.

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XTalks

AUGUST 22, 2022

XTALKS WEBINAR: Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format and Additional Pharma Annual Deadlines. Register for this free webinar to learn how pharmaceutical companies can navigate through structured product labeling requirements and other new guidelines.

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XTalks

NOVEMBER 9, 2022

In this episode, Ayesha and the editorial team spoke with Peter Sallstig, MD, MBA, Global Head of Product Development Division and Chief Medical Officer (CMO) at Santen Pharmaceuticals, a biotech company focused on leveraging key, innovative technologies to develop solutions for eye-related problems worldwide.

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XTalks

AUGUST 30, 2023

The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. The states say the $13.5 million settlement offer from Eli Lilly doesn’t come close to the $1 billion worth of claims the company is facing.

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XTalks

DECEMBER 18, 2024

The most common form of CAH, 21-hydroxylase deficiency, disrupts hormone production, leading to cortisol deficiency and an overproduction of androgens. This imbalance causes a variety of health issues, including abnormal growth, early puberty, infertility and life-threatening adrenal crises.

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XTalks

APRIL 11, 2025

In 2024 its first year operating as a standalone global biosimilars enterprise BioconBiologics launched more than 60 products across emerging and established markets. This action slows tumor growth in difficulttotreat cancers such as metastatic colorectal cancer and nonsmall cell lung cancer.

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XTalks

OCTOBER 24, 2024

Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA). Amgen also partnered with actor and entrepreneur La La Anthony to raise awareness about the impact of psoriasis on daily life.

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XTalks

MAY 29, 2024

Lee integrated protein crystallography and structural screening technologies into the company’s research programs and was instrumental in the development of phosphoinositide 3-kinase (PI3K) delta inhibitors, leading to an FDA-approved product. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

OCTOBER 27, 2021

In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech.

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XTalks

JANUARY 20, 2025

From Bristol-Myers Squibbs monumental acquisition of Celgene to Pfizers recent purchase of Seagen, these deals illustrate the strategies and ambitions driving innovation in life sciences. Key drivers of the acquisition included Allergans robust product portfolio, particularly in ophthalmology, neuroscience and aesthetics.

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XTalks

JULY 26, 2024

The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.

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XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain. By lowering its production, Tryngolza significantly reduces triglyceride levels in the blood.

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XTalks

MARCH 21, 2025

With a 30-month shelf life and rapid absorption, Neffy offers an on-the-go alternative to auto-injectors. Following Neffys FDA approval , ARS Pharma reported $2.3 Iovance Biotherapeutics Iovances Amtagvi (lifileucel) is FDA-approved as the first tumor-infiltrating lymphocyte (TIL)-based therapy for solid tumors.

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XTalks

JANUARY 29, 2025

This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval. Zepbound was approved in 2023 as the obesity counterpart of Eli Lillys GLP-1 blockbuster Mounjaro. Its changing how much weight I lose, up to 48 lbs, he says.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. point reduction in the placebo arm.

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XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

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