XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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XTalks

DECEMBER 13, 2023

While Lyfgenia delivers a functional copy of hemoglobin A to replace the abnormal one in hematopoietic (blood) stem cells via a lentiviral vector, Casgevy edits the HBB gene using CRISPR technology to increase the production of fetal hemoglobin in blood stem cells.

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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 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

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

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, a first-in-class IL-15 agonist immunotherapy, is ImmunityBio’s first approved product.

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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

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

DECEMBER 2, 2022

Related: Nestlé to Market Seres’ Oral Microbiome Drug for C. As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER).

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XTalks

OCTOBER 17, 2023

Velsipity’s FDA approval today marks a significant milestone for UC patients who need new treatments for this chronic condition and are ready to start advanced therapy.” The global market for inflammatory bowel diseases is rather lucrative at about $20 billion. Velsipity was the main feature in Pfizer’s $6.7

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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

AUGUST 22, 2022

What sets Auvelity apart from other antidepressants on the market is its ability to act rapidly. Additionally, Axsome says Auvelity is the first oral MDD medication with a new mechanism of action to hit the market in more than 60 years. Live and On-Demand: Wednesday, September 21, 2022, at 2pm EDT (11am PDT).

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XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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XTalks

AUGUST 2, 2022

The FDA finally inspected the site in January this year. According to Azurity, Zonisade is the first and only zonisamide formulation for oral liquid administration to be FDA approved as an adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.

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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

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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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

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). Reduced tear production is another cause of the disease. Last year, the FDA approved the first generic version of Restasis.

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pharmaphorum

SEPTEMBER 30, 2022

However, despite the growing number of available products focusing on the same target, prices are not showing the significant decrease that one might expect from a rapidly commoditising market. sugemalimab) to market at “radically lower”, disruptive price points when compared to current options1.

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XTalks

OCTOBER 7, 2022

In Japan, an ophthalmic solution known as Eybelis was launched in November 2018 for managing elevated IOP, and subsequently filed for marketing approval in several more countries in Asia. Eventually, it was released in five countries beginning in February 2021. Live and On-Demand: Wednesday, October 12, 2022, at 11am EST (4pm BST/UK).

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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

AUGUST 18, 2020

“Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America.”. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

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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 said it has secured about two-thirds share of the US market where nearly all of Arexvy’s sales were recorded. For Arexvy, the company is seeking expanded approval for adults 50 to 59 years old for a further boost.

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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. However, the drug will lose its market exclusivity in 2023, at which time Jazz hopes patients will shift to Xywav. In 2020, it garnered $1.74 billion in sales.

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XTalks

NOVEMBER 28, 2023

Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs. The biosimilar industry today is marked by rapid advancements, regulatory evolution and growing market acceptance.

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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. 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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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

SEPTEMBER 12, 2023

Life science podcasts have emerged as an invaluable tool for building connections with audiences in the digital era. Furthermore, we’ll explore the unique advertising opportunities that this platform offers, positioning brands at the forefront of the life science industry. The result?

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XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Present and Future Prospects for the Imaging Agents Market In 2021, the market value of imaging agents was reported to be over $9.2 billion by 2030, according to a report by Global Market Insights.

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XTalks

DECEMBER 19, 2022

Register for this free webinar to learn about the value of imaging data as a real-world data source, and the power of linking it with clinical data stored in electronic health records (EHRs) to inform research across the drug and device lifecycle for life sciences. The NDA FDA approval is a milestone for the Thea Group.

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Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

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Drug Discovery World

MARCH 16, 2023

The cell and gene therapy (CGT) market is rapidly expanding, and projections suggest it will reach over $90B by 2023. With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. These steps will pave the way for reliable protocol standardisation to transform CGT manufacturing and production.

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XTalks

NOVEMBER 27, 2023

Amicus Therapeutics has recently received approval from the US Food and Drug Administration (FDA) for its drugs Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for adults living with late-onset Pompe disease (LOPD) who are not improving on their current enzyme replacement therapy (ERT).

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XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution.

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XTalks

DECEMBER 20, 2023

The market for pain management is both complex and substantial, driven by a growing patient population and evolving medical needs. Chronic pain affects millions of people worldwide, significantly impacting their quality of life and posing a substantial economic burden on healthcare systems. billion in 2023 to $89.96

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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. In its first quarter on the market since its approval, sales totalled $97 million between July and September in the US.

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XTalks

MAY 29, 2024

The global pharmaceutical market has been expanding at an unprecedented pace. According to Statista , in 2023, the market was estimated to be worth about $1.6 The top ten pharma companies in 2023 by revenue accounted for about 35 percent of the market value, with total earnings of $559.5 billion last year, up 4.2 billion).

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